1

This table represents the combined work of the Professional Practice Committee leading up to and during their August 2017 meeting. This evidence table is for illustrative, educational, and historical purposes only. The recommendations and support continued to evolve after

the meeting; refer to the Standards of Medical Care in Diabetes for the official ADA recommendations and support, or for methodological details.

2017 Recommendation

2018 Recommendation (Use Tracked Changes if updating 2017 recommendation)

Reason for Change/Rationale for New Recommendation

2017 Citations & New References

Example: For all patients, testing should begin at age 45 years. B

No Change https://doi.org/10.1016/S0140-6736(09)62162-0 https://doi.org/10.2337/diacare.26.2007.S5

Example: For all patients, testing should begin at age 45 years. B

For all patients, testing should begin at age 4405 years. BA

New RCT indicates that starting to test at age 40 is cost-effective and prevents long-term diabetes complications

https://doi.org/10.1016/S0140-6736(09)62162-0 https://doi.org/10.2337/diacare.26.2007.S5 New 2018 reference: https://doi.org/XXXXXXX

Example: New recommendation

All patients with diabetes should have home blood pressure monitored to identify masked or white coat hypertension. B

Hypertension position statement recommendation with wide applicability, higher level evidence grade, and long-term benefits

New 2018 reference: https://doi.org/XXXXXXX

Promoting Health and Reducing Disparities in Populations Treatment decisions should be timely, rely on evidence-based guidelines, and be made collaboratively with patients based on individual preferences,

No Change 6, 10, 12, 17, 22-23, 39

2

prognoses, and comorbidities. B Providers should consider the burden of treatment and self-efficacy of patients when recommending treatments. E

Consider removing • Does not fit theme of chapter

• Reworded from psychosocial statement

• Belongs in section 3, or section 8, if anywhere

Treatment plans should align with the Chronic Care Model, emphasizing productive interactions between a prepared proactive practice team and an informed activated patient. A

Treatment plansApproaches to diabetes management should align with the Chronic Care Model, emphasizing productive interactions between a prepared proactive practice team and an informed activated patient. A

7, 8, 33, 34 No new references

When feasible, care systems should support team-based care, community involvement, patient registries, and decision support tools to meet patient needs. B

When feasible, Ccare systems should support facilitate team-based care, community involvement, patient registries, and decision support tools, and community involvement, to meet patient needs. B

Less equivocal? Could remove community involvement since it gets covered in next recommendations

6, 7, 9-11, 24, 25 New references: Shmittdiel et al. Curr Diab Rep. 2017 May;17(5):31. doi: 10.1007/s11892-017-0858-3. Diabet Med. 2016 Jun;33(6):734-41. doi: 10.1111/dme.13090.

Quality improvement efforts should

Elaborate in text on data metrics, and include references to

6, 21

3

incorporate reliable data metrics with simultaneous emphasis on quality of care, health outcomes and cost. E (?)

national quality improvement strategies

New references:

https://www.niddk.nih.gov/health-information/health-communication-programs/ndep/health-care-professionals/practice-transformation/defining-quality-care/diabetes-care-quality/Pages/default.aspx

http://www.ajmc.com/journals/evidence-based-diabetes-management/2016/march-2016/getting-to-better-care-and-outcomes-for-diabetes-through-measurementes

New references not related to a particular recommendation

include link to the practice transformation steps on NIDDK website

Tailoring Treatment to Reduce Disparities Providers should assess social context, including potential food insecurity, housing stability, and financial barriers, and apply that information to treatment decisions. A

No change 6, 7, 60

New Reference:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4945373/pdf/nihms777019.pdf

Patients should be referred to local community resources when available. B

No change 6, 7, 60

4

Patients should be provided with self-management support from lay health coaches, navigators, or community health workers when available. A

No change 54-59

New references not related to a particular recommendation

add 2 new SDH references to background: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4834895/pdf/nihms-755551.pdf, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4950677/pdf/nihms801691.pdf

Classification and Diagnosis of Diabetes Categories of Increased Risk for Diabetes (Prediabetes) Screening for prediabetes and risk for future diabetes with an informal assessment of risk factors or validated tools should be considered in asymptomatic adults. B

No change

Testing for prediabetes and risk for future diabetes in asymptomatic people should be considered in adults of any age who are overweight or obese (BMI >25 kg/m2 or >23 kg/m2 in Asian Americans) and who have one or more additional risk factors for diabetes. B

No change

For all patients, testing should begin at age 45 years. B

No change

5

If tests are normal, repeat testing carried out at a minimum of 3-year intervals is reasonable. C

No change

To test for prediabetes, fasting plasma glucose, 2-h plasma glucose after 75-g oral glucose tolerance test, and A1C are equally appropriate. B

No change

In patients with prediabetes, identify and, if appropriate, treat other cardiovascular disease risk factors. B

No change

Testing for prediabetes should be considered in children and adolescents who are overweight or obese and who have two or more additional risk factors for diabetes. E

No change

New references not related to a particular recommendation

Type 1 Diabetes Blood glucose rather than A1C should be used to diagnose acute onset of type 1 diabetes in individuals with

No change

6

symptoms of hyperglycemia. E Screening for type 1 diabetes with a panel of autoantibodies is currently recommended only in the setting of a research trial or in first-degree family members of a proband with type 1 diabetes. B

Screening for type 1 diabetes with a panel of autoantibodies is currently recommended only in the setting of a research trial or in first-degree family members of a proband with type 1 diabetes. BA

Guillermo suggested this change but did not provide justification or additional references.

Persistence of two or more autoantibodies predicts clinical diabetes and may serve as an indication for intervention in the setting of a clinical trial. Outcomes may include reversion of autoantibody status, prevention of glycemic progression within the normal or prediabetes range, prevention of clinical diabetes, or preservation of residual C-peptide secretion. A

Persistence of two or more autoantibodies predicts clinical diabetes and may serve as an indication for intervention in the setting of a clinical trial. Outcomes may include reversion of autoantibody status, prevention of glycemic progression within the normal or prediabetes range, prevention of clinical diabetes, or preservation of residual C-peptide secretion. A

Outcomes should not be a recommendation (Guillermo)

New references not related to a particular recommendation

Type 2 Diabetes Screening for type 2 diabetes with an informal assessment of risk

No change

7

factors or validated tools should be considered in asymptomatic adults. B Testing for type 2 diabetes in asymptomatic people should be considered in adults of any age who are overweight or obese (BMI >25 kg/m2 or >23 kg/m2 in Asian Americans) and who have one or more additional risk factors for diabetes. B

No change

For all people, testing should begin at age 45 years. B

No change

If tests are normal, repeat testing carried out at a minimum of 3-year intervals is reasonable. C

No change

To test for type 2 diabetes, fasting plasma glucose, 2-h plasma glucose after 75-g oral glucose tolerance test, and A1C are equally appropriate. B

No change

To avoid misdiagnosis or missed diagnosis, the A1C should be performed using a method that is certified by the

Currently SOC recommends repeating the same test (A1c for FBS or OGTT that was used to make the diagnosis. However, the new data showing higher

8

NGSP. A1c compared to BG for African Americans (unrelated to the issue of interference with variant Hb) means that African Americans may be over-diagnosed with DM. This could have adverse effects with regard to insurance, employment etc. I think we could consider recommending that if the diagnosis is made with A1c it should be confirmed with a glucose measurement FBG or OGTT. The reference is http://annals.org/aim/article/2631725/racial-differences-relationship-glucose-concentrations-hemoglobin-1c-levels

For patients with abnormal hemoglobin or increased red blood cell turnover, consider using only blood glucose criteria to diagnose diabetes.

See above

In patients with diabetes, identify and, if appropriate, treat other cardiovascular disease risk factors. B

No change

Testing for type 2 diabetes should be considered in children and adolescents who are overweight or obese and who

No change

9

have two or more additional risk factors for diabetes. E New references not related to a particular recommendation

Gestational Diabetes Mellitus Test for undiagnosed diabetes at the first prenatal visit in those with risk factors, using standard diagnostic criteria. B

No change

Test for gestational diabetes mellitus at 24–28 weeks of gestation in pregnant women not previously known to have diabetes. A

No change

Test women with gestational diabetes mellitus for persistent diabetes at 4–12 weeks‘ postpartum, using the oral glucose tolerance test and clinically appropriate non-pregnancy diagnostic criteria. E

No change

Women with a history of gestational diabetes mellitus should have lifelong screening for the development of diabetes or

No change Noctor E, Crowe C, Carmody LA et al: Abnormal glucose tolerance post-gestational diabetes mellitus as defined by the International Association of Diabetes and Pregnancy

10

prediabetes at least every 3 years. B

Study Groups criteria. European Journal of Endocrinology 2016; 175:287-297. (B) Prospective follow-up study (mean 2.6 years) of 270 previous GDMs (IADPSG) and 388 normal controls. 2% developed diabetes and 24% developed prediabetes vs 0 and 4% of controls. 60% of those developing abnormal glucose tolerance already had done so at early postpartum testing.

Women with a history of gestational diabetes mellitus found to have prediabetes should receive intensive lifestyle interventions or metformin to prevent diabetes. A

No change

New references not related to a particular recommendation

a. “One-step strategy,”middle of first paragraph Sacks DA, Hadden DR, Maresh M, Deerochanawong C, Dyer AR, Metzger BE, Lowe LP, Coustan DR, Hod M, Oats JJN, Persson B, Trimble ER for the HAPO Study Cooperative Research Group: The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study: frequency of gestational diabetes mellitus (GDM) at collaborating centers based on IADPSG consensus panel recommended criteria. Diabetes Care 35:526-528, 2012. [Large observational study, low likelihood of bias, B?] Supports statement that increased GDM with one-step strategy is primarily due to one elevated value, not the criteria. B. “One-step strategy,” end of second paragraph Tam WH, Man RCW, Ozaki R et al: In utero exposure to maternal hyperglycemia increases cardiometabolic risk in offspring. Diab Care 2017; 40: 679-686. [observational cohort study, possible bias due to single

11

ethnic population, C?] Landon MB, Rice MM, Varner MW et al: Mild gestational diabetes mellitus and long-term child health. Diab Care 2015; 38:445-452 (followup of RCT, A) Possibly add sentences to the effect: Ho et al. PLoS One. 2017 May 15;12(5):e0177563. doi: 10.1371/journal.pone.0177563. eCollection 2017. Associations of mid-pregnancy HbA1c with gestational diabetes and risk of adverse pregnancy outcomes in high-risk Taiwanese women.

Monogenic Diabetes Syndromes All children diagnosed with diabetes in the first 6 months of life should have immediate genetic testing for neonatal diabetes. A

No change

Children and adults, diagnosed in early adulthood, who have diabetes not characteristic of type 1 or type 2 diabetes that occurs in successive generations (suggestive of an autosomal dominant pattern of inheritance) should have genetic testing for maturity-onset diabetes of the young. A

No change

In both instances, consultation with a center specializing in diabetes genetics is

No change

12

recommended to understand the significance of these mutations and how best to approach further evaluation, treatment, and genetic counseling. E New references not related to a particular recommendation

Diabetes Care. 2017 Aug;40(8):1017-1025. doi: 10.2337/dc17-0224.

Population-Based Assessment of a Biomarker-Based Screening Pathway to Aid Diagnosis of Monogenic Diabetes in Young-Onset Patients. Shields BM1,2, Shepherd M1,2, Hudson M1, McDonald TJ1,3, Colclough K4, Peters J5, Knight B1,2, Hyde C5, Ellard S1,4, Pearson ER6, Hattersley AT7,2; UNITED study team.

Cystic Fibrosis-Related Diabetes Annual screening for cystic fibrosis–related diabetes with oral glucose tolerance test should begin by age 10 years in all patients with cystic fibrosis not previously diagnosed with cystic fibrosis–related diabetes. B

No change

A1C as a screening test for cystic fibrosis–related diabetes is not recommended. B

No change

Patients with cystic fibrosis–related diabetes should be treated with insulin to attain individualized glycemic goals. A

No change

13

Beginning 5 years after the diagnosis of cystic fibrosis–related diabetes, annual monitoring for complications of diabetes is recommended. E

No change

New references not related to a particular recommendation

Sensitivity and specificity of different methods for cystic fibrosis-related diabetes screening: is the oral glucose tolerance test still the standard? Mainguy C, Bellon G, Delaup V, Ginoux T, Kassai-Koupai B, Mazur S, Rabilloud M, Remontet L, Reix P. J Pediatr Endocrinol Metab. 2017 Jan 1;30(1):27-35. doi: 10.1515/jpem-2016-0184. Current gui for Dx and Rxdelines: Moran A., Brunzell C., Cohen R. C., et al. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care. 2010;33(12):2697–2708.

Posttransplantation Diabetes Mellitus Patients should be screened after organ transplantation for hyperglycemia, with a formal diagnosis of posttransplantation diabetes mellitus being best made once a patient is stable on an immunosuppressive regimen and in the absence of an acute infection. E

No change New references: Sharif A, Hecking M, de Vries AP et al. Proceedings from an international consensus meeting on posttransplantation diabetes mellitus: recommendations and future directions. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 2014;14:1992-2000. Hecking M, Werzowa J, Haidinger M et al. Novel views on new-onset diabetes after

14

transplantation: Development, prevention and treatment. Nephrology, Dialysis, Transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2013;28:550-66. Galindo RJ, Wallia A. Hyperglycemia and Diabetes Mellitus Following Organ Transplantation. Curr Diab Rep. 2016 Feb;16(2):14.

The oral glucose tolerance test is the preferred test to make a diagnosis of posttransplantation diabetes mellitus. B

No change

Immunosuppressive regimens shownto provide the best outcomes for patient and graft survival should be used, irrespective of posttransplantation diabetes mellitus risk. E

No change

New references not related to a particular recommendation

Comprehensive Medical Evaluation and Assessment of Comorbidities Patient-Centered Collaborative Care A patient-centered communication style that uses

A patient-centered communication style that uses

Include language from position paper.

Reference the yet-to-be published language paper.

15

active listening, elicits patient preferences and beliefs, and assesses literacy, numeracy, and potential barriers to care should be used to optimize patient health outcomes and health-related quality of life. B

person-centerd, strength-based language, active listening, elicits patient preferences and beliefs, and assesses literacy, numeracy, and potential barriers to care should be used to optimize patient health outcomes and health-related quality of life. B

A complete medical evaluation should be performed at the initial visit to: Confirm the diagnosis and classify diabetes. B

No change

Detect diabetes complications and potential comorbid conditions. E

No change

Review previous treatment and risk factor control in patients with established diabetes. E

No change

Begin patient engagement in the formulation of a care management plan. B

No change

Develop a plan for continuing care. B

No change

A follow up visit should include most components of the initial comprehensive medical evaluation including interval medical history, physical

We will have a new follow-up visit table **Will need to discuss wording of this new recommendation as a group - I have drafted here (RK)

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examination, and laboratory evaluation as appropriate to assess risk for complications, diabetes self-management behaviors, nutrition, psychosocial health, and the need for referrals, immunizations, or other routine health maintenance screening. B

New references not related to a particular recommendation

New table 3.1 with follow up visit column

Immunization Provide routine vaccinations for children and adults with diabetes according to age-related recommendations. C

No change

Annual vaccination against influenza is recommended for all persons with diabetes >6 months of age. C

No change

Vaccination against pneumonia is recommended for all people with diabetes 2 through 64 years of age with pneumococcal polysaccharide vaccine (PPSV23). At age >65 years,

Pneumococcal vaccine is recommended for all people with diabetes 2 through 64 years of age. Children 2 through 18 years of age with diabetes should get at least

Slight rewording based on comments received that this vaccine is not just against pneumonia **We may want someone from CDC to take a look to address the other 2 comments:

These recommendations are taken directly from CDC page 2: https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf and

17

administer the pneumococcal conjugate vaccine (PCV13) at least 1 year after vaccination with PPSV23, followed by another dose of vaccine PPSV23 at least 1 year after PCV13 and at least 5 years after the last dose of PPSV23. C

1 dose of pneumococcal conjugate vaccine (PCV13) if they have not previously received this vaccine. Children and adults with diabetes should also receive pneumococcal polysaccharide vaccine (PPSV23). At age >65 years, administer PCV13 at least 1 year after vaccination with PPSV23, followed by another dose of vaccine PPSV23 at least 1 year after PCV13 and at least 5 years after the last dose of PPSV23. C

--a very brief description of ACIP's recs for persons 65+ that does not include the other 2 options. --Vaccination is not only against pneumococcal pneumonia. --the over 65 statement and its recommendation is misleading and not consistent with CDC recommendation.

https://www.cdc.gov/vaccines/vpd/pneumo/hcp/who-when-to-vaccinate.html

Administer 3-dose series of hepatitis B vaccine to unvaccinated adults with diabetes who are aged 19–59 years. C

No change

Consider administering 3-dose series of hepatitis B vaccine to unvaccinated adults with diabetes who are aged ≥60 years. C

No change

New references not related to a particular recommendation

New figure for Immunizations

Autoimmune Diseases

18

Consider screening patients with type 1 diabetes for autoimmune thyroid disease and celiac disease soon after diagnosis. E

Complications group: No change Guillermo: Consider screening patients with type 1 diabetes for autoimmune thyroid disease and celiac disease soon after diagnosis. BE

Large number of studies support this recommendation Approximately 20%-25% of patients with T1D have thyroid antibodies, and up to 50% of such patients progress to clinical autoimmune thyroid disease.

Hughes JW1, et al. J Clin Endocrinol Metab. 2016 Dec;101(12):4931-4937. Autoimmune Diseases in Children and Adults With Type 1 Diabetes From the T1D Exchange Clinic Registry. Kahaly GJ and Hansen MP. Autoimmun Rev. 2016 Jul;15(7):644-8. Type 1 diabetes associated autoimmunity. Prevalence of Celiac Disease in 52,721 Youth With Type 1 Diabetes: International Comparison Across Three Continents. Craig ME et al. Diabetes Care. 2017 Aug;40(8):1034-1040. Pham-Short A et al. Pediatrics. 2015 Jul;136(1):e170-6. Screening for Celiac Disease in Type 1 Diabetes: A Systematic Review.

New references not related to a particular recommendation

Cognitive Impairment/Dementia In people with cognitive impairment/dementia, intensive glucose control cannot be expected to remediate deficits. Treatment should be tailored

In people with history of cognitive impairment/dementia, intensive glucose control cannot be expected to remediate deficits. Treatment should be tailored

Minor word change in first sentence

19

to avoid significant hypoglycemia. B

to avoid significant hypoglycemia. B

HIV Patients with HIV should be screened for diabetes and prediabetes with a fasting glucose level every 6–12 months before starting antiretroviral therapy and 3 months after starting or changing antiretroviral therapy. If initial screening results are normal, checking fasting glucose every year is advised. If prediabetes is detected, continue to measure fasting glucose levels every 3–6 months to monitor for progression to diabetes. E

No change no change to recommendation, but new literature may come to publish this fall. waiting to hear pub date to determine if we can support incr level of evidence (HF)

Emerging study in Spectrum (Hope)

In men with diabetes who have symptoms or signs of hypogonadism such as decreased sexual desire (libido) or activity, consider screening with a morning serum testosterone level. B

This is a recommendation even for men without diabetes; the recommendation draws attention to this condition which is more prevalent in men with diabetes and can potentially be treated (with testosterone therapy).

See endocrine society guidelines for screening of hypogonadism: https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2009-2354

New references

20

not related to a particular recommendation Anxiety Disorders—Ask Alicia to Review Consider screening for anxiety in people exhibiting anxiety or worries regarding diabetes complications, insulin injections or infusion, taking medications, and/or hypoglycemia that interfere with self-management behaviors and those who express fear, dread, or irrational thoughts and/or show anxiety symptoms such as avoidance behaviors, excessive repetitive behaviors, or social withdrawal. Refer for treatment if anxiety is present. B

Persons with hypoglycemic unawareness, which can co-occur with fear of hypoglycemia, should be treated using blood glucose awareness training (or other evidence-based similar intervention) to help re-establish awareness of

21

hypoglycemia and reduce fear of hypoglycemia. A New references not related to a particular recommendation

Depression—Ask Alicia to Review Providers should consider annual screening of all patients with diabetes, especially those with a self-reported history of depression, for depressive symptoms with ageappropriate depression screening measures, recognizing that further evaluation will be necessary for individuals who have a positive screen. B

As per suggestion from U Mich psychologist – Bill Hermann’s contact.

Amend text that says, “Thus routine screening for depressive sx is indicated in this high-risk population including people with prediabetes (particularly those who are overweight), t1D, t2D….” to OMIT the “prediabetes” recommendation.

Beginning at diagnosis of complications or when there are significant changes in medical status, consider assessment for depression. B

Referrals for treatment of depression should be made to mental health providers with experience using cognitive

22

behavioral therapy, interpersonal therapy, or other evidence-based treatment approaches in conjunction with collaborative care with the patient’s diabetes treatment team. A New references not related to a particular recommendation

Disordered Eating Behavior—Ask Alicia to review Providers should consider reevaluating the treatment regimen of people with diabetes who present with symptoms of disordered eating behavior, an eating disorder, or disrupted patterns of eating. B

Consider screening for disordered or disrupted eating using validated screening measures when hyperglycemia and weight loss are unexplained based on self-reported behaviors related to medication dosing, meal plan, and physical activity. In addition, a review

23

of the medical regimen is recommended to identify potential treatment-related effects on hunger/caloric intake. B New references not related to a particular recommendation

Serious Mental Illness—Ask Alicia to Review Annually screen people who are prescribed atypical antipsychotic medications for prediabetes or diabetes. B

If a second-generation antipsychotic medication is prescribed for adolescents or adults with diabetes, changes in weight, glycemic control, and cholesterol levels should be carefully monitored and the treatment regimen should be reassessed. C

Incorporate monitoring of diabetes self-care activities into treatment goals in people with diabetes and serious mental illness. B

24

New references not related to a particular recommendation

Lifestyle Management Diabetes Self-Management Education and Support In accordance with the national standards for diabetes self-management education and support, all people with diabetes should participate in diabetes self-management education to facilitate the knowledge, skills, and ability necessary for diabetes self-care and in diabetes self-management support to assist with implementing and sustaining skills and behaviors needed for ongoing self-management, both at diagnosis and as needed thereafter. B

In accordance with the national standards for diabetes self-management education and support, all people with diabetes are toshould participate in diabetes self-management education to facilitate the knowledge, skills, and ability necessary for diabetes self-care and in diabetes self-management support to assist with implementing and sustaining skills and behaviors needed for ongoing self-management, both at diagnosis and as needed thereafter. B

Slight adaptation to allow for new recommendation specific to the “4 critical times”.

Updated NSDSMES

There are four critical times to evaluate the need for DSMES:at diagnosis, annually, when complicating factors arise and

Power, et al. Joint Position Statement. (this has been previously reference, but never a recommendation on its own)

25

when transitions in care occur. E

Effective self-management and improved clinical outcomes, health status, and quality of life are key goals of diabetes self-management education and support that should be measured and monitored as part of routine care. C

Effective self-management and improved clinical outcomes, health status, and quality of life are key goals of diabetes self-management education and support that shouldto be measured and monitored as part of routine care. C

Twoupdated papers showing improved outcomes after DSMES: DOI 10.1007/s12020-016-1168-2 (He X, et al Endocrine 2017) doi: 10.1097/MLR.0000000000000653 Strawbridge; Med Care Apr 2017 – evidence of lower costs and lower HC utilization.

Diabetes self-management education and support should be patient centered, respectful, and responsive to individual patient preferences, needs, and values and should help guide clinical decisions. A

Diabetes Effective DSMES isself-management education and support should beis patient centered, may be group, individual or involve an educational technology platform., includes multiple interventions, and is respectful, and responsive to individual patient preferences, needs, and values and should help guide clinical decisionsdesigned to help the individual with problem solving skills and to attain

Benefits of technology: doi: 10.1177/1932296817713506 Greenwood et al. Systematic review. JD Sci and Tech Text: cite evidence of better outcomes if over 10 hours of contact/education. (Chvalra)

26

ongoing support to make self-management decisions. A

Diabetes self-management education and support programs have the necessary elements in their curricula to delay or prevent the development of type 2 diabetes. Diabetes self-management education and support programs should therefore be able to tailor their content when prevention of diabetes is the desired goal. B

Diabetes self-management education and support programs services have the necessary elements in their curricula to delay or prevent the development of type 2 diabetes. Diabetes self-management education and support programs should therefore be able to tailor their content when prevention of diabetes is the desired goal. B

I might omit this – as to me, it reads about prevention. Already covered there. See chapter 5 – s46

Because diabetes self-management education and support can improve outcomes and reduce costs B, diabetes self-management education and support should be adequately reimbursed by third-party payers. E

Because diabetes self-management education and support can improve outcomes and reduce costs B, adequate reimbursement by third-party payers is recommended. diabetes self-management education and support should be adequately reimbursed by third-party payers. E

(references cited above for cost-savings and improved outcomes)

27

New references not related to a particular recommendation

Nutrition Therapy An individualized MNT program, preferably provided by a registered dietitian, is recommended for all people with type 1 or type 2 diabetes. A

An individualized MNT program, preferably provided by a registered dietitian, is recommended for all people with type 1, type 2 and GDM. or type 2 diabetes. A

Franz, et al. Systematic Review MNT DOI:

10.1016/j.jand.2017.03.022

J Acad Nutr Diet. 2017 May 19. pii: S2212-2672(17)30332-5. doi: 10.1016/j.jand.2017.03.022. [Epub ahead of print]

For people with type 1 diabetes or those with type 2 diabetes who are prescribed a flexible insulin therapy program, education on how to use carbohydrate counting and in some cases fat and protein gram estimation to determine mealtime insulin dosing can improve glycemic control. A

Move under proposed new “carb” section

Additional support to add to ref 68,69 Paterson, Smart et al: https://www.ncbi.nlm.nih.gov/pubmed/26499756

For individuals whose daily insulin dosing is fixed, having a consistent pattern of carbohydrate intake with respect to time and amount can result in improved glycemic control and a reduced risk of hypoglycemia. B

Move under proposed new “carb” section

A simple and No change

28

effective approach to glycemia and weight management emphasizing portion control and healthy food choices may be more helpful for those with type 2 diabetes who are not taking insulin, who have limited health literacy or numeracy, and who are elderly and prone to hypoglycemia. C Because diabetes nutrition therapy can result in cost savings B and improved outcomes (e.g., A1C reduction) A, MNT should be adequately reimbursed by insurance and other payers. E

No change

Modest weight loss achievable by the combination of reduction of calorie intake and lifestyle modification benefits overweight or obese adults with type 2 diabetes and also those with prediabetes. Intervention programs to facilitate this process are

No change Hamdy et al. BMJ Open access. Jan 2017. 5 yr maintenance. DOI: 10.1136/bmjdrc-2016-000259

29

recommended. A As there is no single ideal dietary distribution of calories among carbohydrates, fats, and proteins for people with diabetes, macronutrient distribution should be individualized while keeping total calorie and metabolic goals in mind. E

No change Snorgaard, et al. 2017 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5337734/ (low to moderate carb diets

A variety of eating patterns are acceptable for the management of type 2 diabetes and prediabetes including Mediterranean, DASH, and plant-based diets. B

No change Article lending more emphasis to QUALITY: Schwingshackl: AJCN 2017 http://ajcn.nutrition.org/content/105/6/1462

For youth with T1D, place emphasis on diet quality [EVIDENCE LEVEL]

David Maahs to inform from PS

Nansel. AJCN 2016 DOI: 10.3945/ajcn.115.126136 DOI: 10.1016/j.diabres.2017.02.022; Fortin; Diabetes Res Clin Practice 2017 Carb counting can be hard. Katz: doi: 10.1089/dia.2013.0389

Create new “topic” in MNT table- Carbohydrate Carbohydrate intake from whole grains, vegetables, fruits, legumes, and

Advise Carbohydrate intake from whole grains, vegetables,

Include word “added”

30

dairy products, with an emphasis on foods higher in fiber and lower in glycemic load, should be advised over other sources, especially those containing sugars. B

fruits, legumes, and dairy products, with an emphasis on foods higher in fiber and lower in glycemic load, should be advised overinstead of other sources, especially those containing added sugars. B

For T2D, no clear advantages of low or high carb. Emphasis should continue to be on low calorie (Sacha – plz review! …(20-50 gam carb/day) While some studies have shown short term benefit –can be a jump-start to lifestyle change – but longer term use may not be necessary or effective (and has not been well studied.

Van Wyk et al. Diabetic Medicine 2016 https://www.ncbi.nlm.nih.gov/pubmed/26413954 Snorgaard: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5337734/ Tay: https://www.ncbi.nlm.nih.gov/pubmed/26224300 Jung: https://www.ncbi.nlm.nih.gov/pubmed/26224300 Ketogenic: Goday https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5048014/ online intervention: saslow: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5329646/

People with diabetes and those at risk should avoid

No change DOI: 10.3945/ajcn.116.145391 Huang, et al. Updated

31

sugar-sweetened beverages in order to control weight and reduce their risk for CVD and fatty liver B and should minimize the consumption of foods with added sugar that have the capacity to displace healthier, more nutrient-dense food choices. A

SSB article.

In individuals with type 2 diabetes, ingested protein appears to increase insulin response without increasing plasma glucose concentrations. Therefore, carbohydrate sources high in protein should not be used to treat or prevent hypoglycemia. B

Delete In individuals with type 2 diabetes, ingested protein appears to increase insulin response without increasing plasma glucose concentrations. Therefore, avoid carbohydrate sources high in protein should not be used to treat or prevent hypoglycemia. B

ADA Saturated Fat Statement 2017 https://www.ncbi.nlm.nih.gov/pubmed/28620111 Also – Jacobson; NLA - doi.org/10.1016/j.jacl.2015.09.002

Whereas data on the ideal total dietary fat content for people with diabetes are inconclusive, an eating plan emphasizing elements of a Mediterranean-style diet rich in monounsaturated fats may improve glucose metabolism

Whereas data on the ideal total dietary fat content for people with diabetes are inconclusive, an eating plan emphasizing elements of a Mediterranean-style diet rich in monounsaturated and polyunsaturated

From 2017 AHA statement: “RCTs and observational studies do not provideclear evidence that ALA reduces the overall incidence of CVD, althought higher intake of ALA may reduce fatal CHD. National Lipid Lifestyle recommendations (Jacobson)

32

and lower CVD risk and can be an effective alternative to a diet low in total fat but relatively high in carbohydrates. B

fats may improve glucose metabolism and lower CVD risk and can be an effective alternative to a diet low in total fat but relatively high in carbohydrates. B

doi.org/10.1016/j.jacl.2015.09.002

Eating foods rich in long-chain ω-3 fatty acids, such as fatty fish (EPA and DHA) and nuts and seeds (ALA) is recommended to prevent or treat CVD B; however, evidence does not support a beneficial role for ω-3 dietary supplements. A

Eating foods rich in long-chain ω-3 fatty acids, such as fatty fish (EPA and DHA) and nuts and seeds (ALA) is recommended to prevent or treat CVDlinked with reduced ASCVD risk B; however, evidence does not support a beneficial role for ω-3 dietary supplements. A

There is no clear evidence that dietary supplementation with vitamins, minerals, herbs, or spices can improve outcomes in people with diabetes who do not have underlying deficiencies, and there may be safety concerns regarding the long-term use of antioxidant supplements such as vitamins E and C and carotene. C

No change

33

Adults with diabetes who drink alcohol should do so in moderation (no more than one drink per day for adult women and no more than two drinks per day for adult men). C

No change

Alcohol consumption may place people with diabetes at increased risk for delayed hypoglycemia, especially if taking insulin or insulin secretagogues. Education and awareness regarding the recognition and management of delayed hypoglycemia are warranted. B

No change In text, can add reference to link between moderate alcohol and reduced T2D risk (in prevention section) Holst. Diabetologia July 2017 doi:10.1007/s00125-017-4359-3

As for the general population, people with diabetes should limit sodium consumption to <2,300 mg/day, although further restriction may be indicated for those with both diabetes and hypertension. B

No change

The use of nonnutritive sweeteners has the potential to reduce overall calorie and carbohydrate intake if substituted for

I would remove the recommendation and speak to the controversy in the literature. Systematic review and metaanalysis

Azad. CMAJ. July 2017 DOI:

10.1503/cmaj.161390

Grotz: safety of sucralose

34

caloric sweeteners and without compensation by intake of additional calories from other food sources. Nonnutritive sweeteners are generally safe to use within the defined acceptable daily intake levels. B

found NNS associated with a modest increase in BMI; did not look at glucose levels.

DOI: 10.1016/j.yrtph.2017.05.011

New references not related to a particular recommendation

Physical Activity Children and adolescents with type 1 or type 2 diabetes or prediabetes should engage in 60 min/day or more of moderate- or vigorous intensity aerobic activity, with vigorous muscle-strengthening and bone-strengthening activities at least 3 days/week. C

No change New article: DOI:

10.1016/S2213-8587(17)30014-1

Most adults with with type 1 C and type 2 B diabetes should engage in 150 min or more of moderate-to-vigorous intensity physical activity per week, spread over at least 3 days/week, with no

No change

35

more than 2 consecutive days without activity. Shorter durations (minimum 75 min/week) of vigorous-intensity or interval training may be sufficient for younger and more physically fit individuals. All adults, and particularly those with type 2 diabetes, should decrease the amount of time spent in daily sedentary behavior. B Prolonged sitting should be interrupted every 30 min for blood glucose benefits, particularly in adults with type 2 diabetes. C

No change

Flexibility training and balance training are recommended 2–3 times/week for older adults with diabetes. Yoga and tai chi may be included based on individual preferences to increase flexibility, muscular strength, and balance. C

No change

New references not related to a

36

particular recommendation Smoking Cessation: Tobacco and e-Cigarettes Advise all patients not to use cigarettes, other tobacco products A, or e-cigarettes. E

No change To be studied by Hope—removal of e-cigarettes. Separate bullet on e-cigs?

Akter S, Goto A, Mizoue T.Smoking and the risk of type 2 diabetes in Japan: A systematic review and meta-analysis.J Epidemiol. 2017 Jul 14. pii: S0917-5040(17)30139-9. doi: 10.1016/j.je.2016.12.017. [Epub ahead of print] Review. PMID:28716381

Include smoking cessation counseling and other forms of treatment as a routine component of diabetes care. B

No change Add West reference for additional support.

New references not related to a particular recommendation

Tian. Assoc btwn smoking cessation and wt gain. DOI: 10.1111/obr.12304 Add as a reference data showing significant weight gain associated with quitters. More weight gain in certain populations (North American) than others (Asia). Lindson-Hawley. Cochrane Review of interventions to reduce harm from continued tobacco use. NRT (nic replacement therapy) can help. DOI: 10.1002/14651858.CD005231.pub3 West. doi: 10.1080/08870446.2017.1325890 PMCID: PMC5490618. Providng behavioral and pharmacologixal support can improve the rate at which quit attempts succees.

Psychological Issues Psychosocial care should be integrated with a collaborative,patient-centered approach and provided to all people with diabetes, with the goals of optimizing

No change

37

health outcomes and health-related quality of life. A Psychosocial screening and follow-up may include, but are not limited to, attitudes about the illness, expectations for medical management and outcomes, affect or mood, general and diabetes-related quality of life, available resources (financial, social, and emotional), and psychiatric history. E

No change

Providers should consider assessment for symptoms of diabetes distress, depression, anxiety, disordered eating, and cognitive capacities using patient-appropriate standardized and validated tools at the initial visit, at periodic intervals, and when there is a change in disease, treatment, or life circumstance. Including caregivers and family members in this assessment is recommended. B

No change Suggest adding back in the paragraph from 2016 – pg s30, “The screening of all pts with DM with the PHQ2 and either the DDS-2 or PAID-1 can help to facilitate this.” (to provide a simple screening tool)

Consider screening older adults (aged

No change

38

>65 years) with diabetes for cognitive impairment and depression. B Routinely monitor people with diabetes for diabetes distress, particularly when treatment targets are not met and/or at the onset of diabetes complications. B

No change

New references not related to a particular recommendation

Prevention or Delay of Type 2 Diabetes At least annual monitoring for the development of diabetes in those with prediabetes is suggested. E

No change *Guillermo comments that perhaps this should be a B grade recommendation

* Guillermo “The progression from pre- to diabetes is well demonstrated with periodic screening Correlate with glycemic group

Patients with prediabetes should be referred to an intensive behavioral lifestyle intervention program modeled on the Diabetes Prevention Program to achieve and maintain 7% loss of initial body weight and increase moderate intensity physical activity (such as brisk walking) to at least

No change doi.org/10.2337/dc16-2099 D.Care. Ely et al. 4 year results 2017

Li R. Ann Int Med. Sept 2015. doi: 10.7326/M15-0469 Systematic review showing cost effectiveness of community prevention programs.

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150 min/week. A Technology-assisted tools including Internet-based social networks, distance learning, DVD-based content, and mobile applications may be useful elements of effective lifestyle modification to prevent diabetes. B

Technology-assisted tools including Internet-based social networks, distance learning, DVD-based content, and mobile applications that incorporate bi-directional communication may be useful elements of effective lifestyle modification to prevent diabetes. B

Remove “DVD based content,” as reference from 2010 and newer studies have no statistically sig effect on DVD based content Remove ref #27 (Kramer 2010)

Chen. PLOS One Published online 2016 Oct 5. doi: 10.1371/journal.pone.0163627 Demonstrates clinical and economic benefit of digital DM prevention program. Bian RR, et al.J The Effect of Technology-Mediated Diabetes Prevention Interventions on Weight: A Meta-Analysis. Med Internet Res. 2017 Mar 7;19(3):e76. doi: 10.2196/jmir.4709.

PMID:28347972

A Systematic Review of Reviews Evaluating Technology-Enabled Diabetes Self-Management Education and Support.

Greenwood DA, Gee PM, Fatkin KJ, Peeples M.

J Diabetes Sci Technol. 2017 May 1:1932296817713506. doi: 10.1177/1932296817713506. [Epub ahead of print]

PMID:28560898

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Given the cost-effectiveness of diabetes prevention, such programs should be covered by third-party payers. B

No change Greenwood, D et.al. A Systematic Review of Reviews Evaluating Technology-Enabled Diabetes Self-Management Education and Support

http://journals.sagepub.com/doi/abs/10.1177/1932296817713506?url_ver=Z39.88-003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed&

New references not related to a particular recommendation

Insert updated references in text related to nutrition Alcohol: In text, can add reference to link between moderate alcohol and reduced T2D risk (in prevention section) Holst. Diabetologia July 2017 doi:10.1007/s00125-017-4359-3 Yogurt: DOI: 10.1080/10408398.2014.883356 (Pei, Crit Rev Food Sci Nutri; May 2017) and DOI: 10.3945/jn.116.240754 –(Wen, J Nutr, factors influenceing gut microbiota, inflammation and T2D) Plant based diets: DOI: 10.1016/j.jacc.2017.05.047 (some meat and plant based is better than no meat, but poor quality. Satija JACC. July 2017 Huang M AJCN. Link with Artifically swtnd beverages and diabetes DOI: 10.3945/ajcn.116.145391

Pharmacologic Interventions Metformin therapy for prevention of type 2 diabetes should be considered in those with prediabetes, especially in those with BMI >35 kg/m2, those aged <60 years, and women with prior gestational diabetes

No change Narrative to include discussion of GLP-1 but no data to support recommendation change

? high risk groups with metformin start – correlate parameters with glycemic group

41

mellitus. A Long-term use of metformin may be associated with biochemical vitamin B12 deficiency, and periodic measurement of vitamin B12 levels should be considered in metformin-treated patients, especially in those with anemia or peripheral neuropathy. B

No change Supportive evidence – no grade change ? annotation of metformin label with indication to monitor?

Aroda VR, Edelstein SL, Goldberg RB, et al.; Diabetes Prevention Program Research Group. Long-term metformin use and vitamin B12 deficiency in the Diabetes Prevention Program Outcomes Study. J ClinEndocrinol Metab 2016;101:1754-1761

Association between metformin and vitamin B12 deficiency in patients with type 2 diabetes: A systematic review and meta-analysis DOI: 10.1016/j.diabet.2016.03.008

New references not related to a particular recommendation

Prevention of CVD Screening for and treatment of modifiable risk factors for cardiovascular disease is suggested for those with prediabetes. B

No change Add references: Bress, AP et al. Diabetes Care Effect of IntensiveVersus Standard Blood Pressure Treatment According to Baseline Prediabetes Status: A Post Hoc Analysis of a Randomized Trial https://doi.org/10.2337/dc17-0885

New references not related to a particular

42

recommendation DSME/S Diabetes self-management education and support programs may be appropriate venues for people with prediabetes to receive education and support to develop and maintain behaviors that can prevent or delay the development of diabetes. B

No change Sun Y. JAND. March 2017 J Acad Nutr Diet. 2017 Mar;117(3):404-421.e36. doi: 10.1016/j.jand.2016.11.016. Cost of interventions by RDs was lower than non-RD interventions

New references not related to a particular recommendation

Li R. Ann Int Med. Sept 2015. doi: 10.7326/M15-0469 Systematic review showing cost effectiveness of community prevention programs.

Glycemic Targets Most patients using intensive insulin regimens (multiple-dose insulin or insulin pump therapy) should perform self-monitoring of blood glucose (SMBG) prior to meals and snacks, at bedtime, occasionally postprandially, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normoglycemic, and prior to critical tasks such as driving. B

No change

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When prescribed as part of a broad educational context, self-monitoring of blood glucose (SMBG) may help to guide treatment decisions and/or self-management for patients taking less frequent insulin injections B or noninsulin therapies. E

No change

When prescribing SMBG, ensure that patients receive ongoing instruction and regular evaluation of SMBG technique, SMBG results, and their ability to use SMBG data to adjust therapy. E

No change

When used properly, continuous glucose monitoring (CGM) in conjunction with intensive insulin regimens is a useful tool to lower A1C in selected adults (aged ≥25 years) with type 1 diabetes. A

No change

Although the evidence for A1C lowering is less strong in children, teens, and younger adults, CGM may be helpful in these groups. Success

No change

44

correlates with adherence to ongoing use of the device. B CGM may be a useful tool in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes. C

No change

Given variable adherence to CGM, assess individual readiness for continuing CGM use prior to prescribing. E

No change

When prescribing CGM, robust diabetes education, training, and support are required for optimal CGM implementation and ongoing use. E

No change

People who have been successfully using CGM should have continued access after they turn 65 years of age. E

No change

New references not related to a particular recommendation

Should add the recent consensus statement Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations Joint Position Statement European Association for the Study of Diabetes and American Diabetes Association Diabetes Technology Working Group. In press

A1C Testing Perform the A1C test at least two times a year in patients who are meeting treatment

No change

45

goals (and who have stable glycemic control). E Perform the A1C test quarterly in patients whose therapy has changed or who are not meeting glycemic goals. E

No change

Point-of-care testing for A1C provides the opportunity for more timely treatment changes. E

No change

New references not related to a particular recommendation

REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes. Aleppo G, et al; REPLACE-BG Study Group. Diabetes Care. 2017 Apr;40(4):538-545. Hirsch IB1, Verderese CA2. Endocr Pract. 2017 Aug 17. doi: 10.4158/EP171962.RA. [Epub ahead of print]. PROFESSIONAL CONTINUOUS FLASH GLUCOSE MONITORING WITH AMBULATORY GLUCOSE PROFILE REPORTING TO SUPPLEMENT A1C: RATIONALE AND PRACTICAL IMPLEMENTATION. Hypoglycemia in Older Adults with Type 1 Diabetes. DuBose SN, Weinstock RS, Beck RW, Peters AL, Aleppo G, Bergenstal RM, Rodriguez H, Largay JF, Massaro EM, Hirsch IB. Diabetes Technol Ther. 2016 Dec;18(12):765-771.

A1C Goals A reasonable A1C goal for many nonpregnant adults is <7% (53 mmol/mol). A

No change Many or most?

Providers might reasonably suggest more stringent A1C

No change

46

goals (such as <6.5% [48 mmol/mol]) for selected individual patients if this can be achieved without significant hypoglycemia or other adverse effects of treatment (i.e. polypharmacy). Appropriate patients might include those with short duration of diabetes, type 2 diabetes treated with lifestyle or metformin only, long life expectancy, or no significant cardiovascular disease. C Less stringent A1C goals (such as <8% [64 mmol/mol]) may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, extensive comorbid conditions, or long-standing diabetes in whom the general goal is difficult to achieve despite diabetes self-management

No change

47

education, appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents including insulin. B New references not related to a particular recommendation

Hypoglycemia Individuals at risk for hypoglycemia should be asked about symptomatic and asymptomatic hypoglycemia at each encounter. C

No change

Glucose (15–20 g) is the preferred treatment for the conscious individual with hypoglycemia (glucose alert value of < 70 mg/dL [3.9 mmol/L]), although any form of carbohydrate that contains glucose may be used. Fifteen minutes after treatment, if SMBG shows continued hypoglycemia, the treatment should be repeated. Once SMBG returns to normal, the individual should consume a meal or snack to prevent recurrence of hypoglycemia. E

No change

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Glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose < 54 mg/dL (3.0 mmol/L), so it is available should it be needed. Caregivers, school personnel, or family members of these individuals should know where it is and when and how to administer it. Glucagon administration is not limited to health care professionals. E

No change

Hypoglycemia unawareness or one or more episodes of severe hypoglycemia should trigger reevaluation of the treatment regimen. E

No change

Insulin-treated patients with hypoglycemia unawareness or an episode of clinically significant hypoglycemia should be advised to raise their glycemic targets to strictly avoid

No change

49

further hypoglycemia for at least several weeks in order to partially reverse hypoglycemia unawareness and reduce risk of future episodes. A CSII and close loop

insulin delivery systems have been shown effective in improving glycemic control and reducing hypoglycemia in intensively treated patients with T1D

N Engl J Med. 2016 Aug 18;375(7):644-54. doi: 10.1056/NEJMoa1602494. Closed-Loop Insulin Delivery during Pregnancy in Women with Type 1 Diabetes. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. Beck RW, D; DIAMOND Study Group. JAMA. 2017

Ongoing assessment of cognitive function is suggested with increased vigilance for hypoglycemia by the clinician, patient, and caregivers if low cognition or declining cognition is found. B

No change

New references not related to a

Diabetes Care. 2016 Jul;39(7):1072-4. doi: 10.2337/dci16-0008. Islet Transplantation

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particular recommendation

for Hypoglycemia Unawareness/Severe Hypoglycemia: Caveat Emptor. Harlan DM1. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Ólafsdóttir AF, Frid A, Wedel H, Ahlén E, Nyström T, Hellman J. JAMA. 2017 Jan 24;317(4):379-387.

Obesity Managment for the Treatment of Type 2 Diabetes Assessment At each patient encounter, BMI should be calculated and documented in the medical record. B

No change 2017 Reference: WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet 2004;363:157-163. New 2018 References: Jensen MD, Ryan DH, Apovian CM, et al.; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol 2014;63(25 Pt B):2985-3023.

Diet, Physical Activity, and Behavioral Therapy Diet, physical No change 2017 References:

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activity, and behavioral therapy designed to achieve >5% weight loss should be prescribed for overweight and obese patients with type 2 diabetes ready to achieve weight loss. A

Look AHEAD Research Group. Eight-year weight losses with an intensive lifestyle intervention: the Look AHEAD study. Obesity (Silver Spring) 2014;22:5-13. Wilding JPH. The importance of weight management in type 2 diabetes mellitus. Int J Clin Pract 2014;68:682-691. Sacks FM, Bray GA, Carey VJ, et al. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med 2009;360:859-873. Johnston BC, Kanters S, Bandayrel K, et al. Comparison of weight loss among named diet programs in overweight and obese adults: a meta-analysis. JAMA 2014;312:923-933. Jensen MD, Ryan DH, Apovian CM, et al.; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of

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Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol 2014;63(25 Pt B):2985-3023. New 2018 References: Franz MJ, Boucher JL, Rutten-Ramos S, et al. Lifestyle weight-loss intervention outcomes in overweight and obese adults with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials. J Acad Nutr Diet 2015;115:1447-1463.

Such interventions should be high intensity (≥16 sessions in 6 months) and focus on diet, physical activity, and behavioral strategies to achieve a 500–750 kcal/day energy deficit. A

No change 2017 References: Franz MJ, Boucher JL, Rutten-Ramos S, et al. Lifestyle weight-loss intervention outcomes in overweight and obese adults with type 2 diabetes: a systematic review and meta-analysis of randomized clinical trials. J Acad Nutr Diet 2015;115:1447-1463. NOTE: listed in 2017 evidence table, but reference in standards (Ref #21) appears incorrect

Diets should be individualized, as those that provide the same caloric restriction but differ in protein, carbohydrate, and fat content are

No change 2017 References: Sacks FM, Bray GA, Carey VJ, et al. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med 2009;360:859-873.

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equally effective in achieving weight loss. A

De Souza RJ, Bray GA, Carey VJ, et al. Effects of 4 weight-loss diets differing in fat, protein, and carbohydrate on fat mass, lean mass, visceral adipose tissue, and hepatic fat: results from the POUNDS LOST trial. Am J Nutr 2012;95:614-625. Johnston BC, Kanters S, Bandayrel K, et al. Comparison of weight loss among named diet programs in overweight and obese adults: a meta-analysis. JAMA 2014;312:923-933. Jensen MD, Ryan DH, Apovian CM, et al.; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol 2014;63(25 Pt B):2985-3023.

For patients who achieve short-term weight loss goals, long-term (≥1-year) comprehensive

No change

2017 References: Gudzune KA, Doshi RS, Mehta AK, et al. Efficacy of commercial weight-loss programs: an updated

54

weight maintenance programs should be prescribed. Such programs should provide at least monthly contact and encourage ongoing monitoring of body weight (weekly or more frequently), continued consumption of a reduced calorie diet, and participation in high levels of physical activity (200–300 min/week). A

systematic review. Ann Intern Med 2015;162:501-512.

To achieve weight loss of >5%, short-term (3-month) interventions that use very low-calorie diets (≤800 kcal/day) and total meal replacements may be prescribed for carefully selected patients by trained practitioners in medical care settings with close medical monitoring. To maintain weight loss, such programs must incorporate long-term comprehensive weight maintenance counseling. B

No change 2017 References: Tsai AG, Wadden TA. The evolution of very-low-carlorie diets: an update and meta-analysis. Obesity (Silver Spring) 2006;14:1283-1293. Johansson K, Neovius M, Hemmingsson E. Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr 2014;99:14-23. Raynor HA, Anderson AM, Miller GD, et al.; Look AHEAD Research Group. Partial meal replacement plan and

55

quality of the diet at 1 year: Action for Health in Diabetes (Look AHEAD) Trial. J Acad Nutr Diet 2015;115:731-742.

New references not related to a particular recommendation

Consider addition of a cross-reference to Chapter 4: Lifestyle Management for additional detail on lifestyle interventions. Bush T, Lovejoy JC, Deprey M, et al. The effect of tobacco cessation on weight gain, obesity, and diabetes risk. Obesity (Silver Spring) 2016;24:1834-1841.

• Consider adding text RE: potential weight gain associated with smoking cessation and implementation of behavioral strategies to minimize weight gain.

Pharmacotherapy When choosing glucose-lowering medications for overweight or obese patients with type 2 diabetes, consider their effect on weight. E

No change

Whenever possible, minimize the medications for comorbid conditions that are associated with weight gain. E

No change

Weight loss medications may be effective as adjuncts to diet, physical activity, and behavioral counseling for selected patients with type 2 diabetes and BMI ≥27 kg/m2. Potential benefits must be weighed against the potential risks of the medications. A

No change 2017 References: Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA 2014;311:74-86. Greenway FL, Fujioka K, Plodkowski RA, et al; COR-I Study Group. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a

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multicenter, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2010;376:595-605. Pi-Sunyer X, Astrup A, Fujioka K, et al.; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med 2015;373:11-22. New 2018 References: Wadden TA, Berkowitz RI, Womble LG, et al. Randomized trial of lifestyle modification and pharmacotherapy for obesity. N Engl J Med 2005;17;353:2111-2120. Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr 2012;95:297-308. O’Neil PM, Smith SR, Weissman NJ, et al. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring)

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2012;20:1426-1436. If a patient’s response to weight loss medications is <5% weight loss after 3 months or if there are any safety or tolerability issues at any time, the medication should be discontinued and alternative medications or treatment approaches should be considered. A

No change 2017 References: Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA 2014;311:74-86. Greenway FL, Fujioka K, Plodkowski RA, et al; COR-I Study Group. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicenter, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2010;376:595-605. Pi-Sunyer X, Astrup A, Fujioka K, et al.; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med 2015;373:11-22. New 2018 References: Wadden TA, Berkowitz RI, Womble LG, et al. Randomized trial of lifestyle modification and pharmacotherapy for obesity. N Engl J Med 2005;17;353:2111-2120. Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in

58

obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr 2012;95:297-308. O’Neil PM, Smith SR, Weissman NJ, et al. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring) 2012;20:1426-1436.

New references not related to a particular recommendation

le Roux CW, Astrup A,Fujioka K, et al. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet 2017;389:1399-1409

• Saxenda label updated to note efficacy and safety data at 3 years Metabolic Surgery Metabolic surgery should be recommended to treat type 2 diabetes in appropriate surgical candidates with BMI >40 kg/m2 (BMI >37.5 kg/m2 in Asian Americans), regardless of the level of glycemic control or complexity of glucose-lowering regimens, and in adults with BMI 35.0–39.9 kg/m2 (32.5–37.4 kg/m2 in Asian Americans) when hyperglycemia is

Metabolic surgery should be recommended as an option to treat type 2 diabetes in appropriate surgical candidates with BMI >40 kg/m2 (BMI >37.5 kg/m2 in Asian Americans), regardless of the level of glycemic control or complexity of glucose-lowering regimens, and in adults with BMI 35.0–39.9 kg/m2 (32.5–37.4 kg/m2 in Asian

Suggested wording change to better align with recommendation from Rubino et al. 2016.

2017 References: Rubino et al. Metabolic Surgery in the treatment algorithm for type 2 diabetes: A joint statement by international diabetes organizations. Diabetes Care 2016;39:861-877 New 2018 References: Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes – 5-year outcomes. N Engl J Med 2017;376:641-651. Ikramuddin S, Korner J, Lee WJ, et al. Durability of addition of roux-en-Y gastric bypass to lifestyle intervention and medical

59

inadequately controlled despite lifestyle and optimal medical therapy. A

Americans) when hyperglycemia is inadequately controlled despite lifestyle and optimal medical therapy. A

management in achieving primary treatment goals for uncontrolled type 2 diabetes in mild to moderate obesity: a randomized control trial. Diabetes Care 2016;39:1510-1508. Sheng B, Truong K, Spitler H, et al. The long-term effects of bariatric surgery on type 2 diabetes remission, microvascular and macrovascular complications, and mortality: a systematic review and meta-analysis. Obes Surg 2017 Aug 11 [Epub ahead of print]

Metabolic surgery should be considered for adults with type 2 diabetes and BMI 30.0–34.9 kg/m2 (27.5–32.4 kg/m2 in Asian Americans) if hyperglycemia is inadequately controlled despite optimal medical control by either oral or injectable medications (including insulin). B

No change 2017 References: Rubino et al. Metabolic Surgery in the treatment algorithm for type 2 diabetes: A joint statement by international diabetes organizations. Diabetes Care 2016;39:861-877 New 2018 References: Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes – 5-year outcomes. N Engl J Med 2017;376:641-651. Ikramuddin S, Korner J, Lee WJ, et al. Durability of addition of roux-en-Y gastric bypass to lifestyle intervention and medical management in achieving primary treatment goals for uncontrolled type 2

60

diabetes in mild to moderate obesity: a randomized control trial. Diabetes Care 2016;39:1510-1508.

Metabolic surgery should be performed in high-volume centers with multidisciplinary teams that understand and are experienced in the management of diabetes and gastrointestinal surgery. C

No change 2017 References: Rubino et al. Metabolic Surgery in the treatment algorithm for type 2 diabetes: A joint statement by international diabetes organizations. Diabetes Care 2016;39:861-877

Long-term lifestyle support and routine monitoring of micronutrient and nutritional status must be provided to patients after surgery, according to guidelines for postoperative management of metabolic surgery by national and international professional societies. C

No change 2017 References: Rubino et al. Metabolic Surgery in the treatment algorithm for type 2 diabetes: A joint statement by international diabetes organizations. Diabetes Care 2016;39:861-877

People presenting for metabolic surgery should receive a comprehensive mental health assessment. B Surgery should be postponed in patients with histories of alcohol or substance abuse,

No change 2017 References: Greenberg I, Sogg S, M Perna F. Behavioral and psychological care in weight loss surgery: best practice update. Obesity (Silver Spring) 2009;17:880-884.

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significant depression, suicidal ideation, or other mental health conditions until these conditions have been fully addressed. E People who undergo metabolic surgery should be evaluated to assess the need for ongoing mental health services to help them adjust to medical and psychosocial changes after surgery. C

No change 2017 References: Greenberg I, Sogg S, M Perna F. Behavioral and psychological care in weight loss surgery: best practice update. Obesity (Silver Spring) 2009;17:880-884.

New references not related to a particular recommendation

Consider addition of submitted NEW Figure 7.1 (Ref: Rubino et al. Metabolic Surgery in the treatment algorithm for type 2 diabetes: A joint statement by international diabetes organizations. Diabetes Care 2016;39:861-877) Tie in New Figure 7.1 with glycemic algorithm in Chapter 8?

Pharmacologic Approaches To Glycemic Treatment Pharmacologic Therapy For Type 1 Diabetes Most people with type 1 diabetes should be treated with multiple daily injections of prandial insulin and basal insulin or continuous subcutaneous insulin infusion. A

No change

Automated insulin delivery systems should be considered in people at high risk of hypoglycemia [Evidence level—670G study

Language from pediatric statement applied to adults—is evidence the same in adults as pediatrics? Include language/references

62

observational not RCT]

from ped statement

Autoislet transplantation should be considered for patients requiring total pancreatectomy for medically refractory chronic pancreatitis. [Evidence level]

References from Judy

Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk. A

No change

Consider educating individuals with type 1 diabetes on matching prandial insulin doses to carbohydrate intake, premeal blood glucose levels, and anticipated physical activity. E

No change

Individuals with type 1 diabetes who have been successfully using continuous subcutaneous insulin infusion should have continued access to this therapy after they turn 65 years of age. E

No change

New references not related to a particular

63

recommendation Pharmacologic Therapy for Type 2 Diabetes Metformin, if not contraindicated and if tolerated, is the preferred initial pharmacological agent for type 2 diabetes. A

No change

Long-term use of metformin may be associated with biochemical vitamin B12 deficiency, and periodic measurement of vitamin B12 levels should be considered in metformin-treated patients, especially in those with anemia or peripheral neuropathy. B

No change Cross reference older adults section, relate to fall risk

Long-term Metformin Therapy and Monitoring for Vitamin B12 Deficiency Among Older Veterans. Kancherla V, et al: J Am Geriatr Soc. 2017 May;65(5):1061-1066.

Consider initiating insulin therapy (with or without additional agents) in patients with newly diagnosed type 2 diabetes who are symptomatic and/or have A1C >10% (86 mmol/mol) and/or blood glucose levels >300 mg/dL (16.7 mmol/L). E

No change

Add recommendation for 9%

If noninsulin monotherapy at maximum tolerated

In patients without ASCVD, if noninsulin

Patterns of glycaemic control in patients with type 2 diabetes mellitus

64

dose does not achieve or maintain the A1C target over 3 months, add a second oral agent, a glucagon-like peptide 1 receptor agonist, or basal insulin. A

monotherapy at maximum tolerated dose does not achieve or maintain the A1C target goal over 3-6 months, add an second additional antihyperglycemc oral agent, a glucagon-like peptide 1 receptor agonist,or basal insulin based on patient factors (Table X). ANo change

initiating second-line therapyafter metformin monotherapy: Retrospective data for 10 256 individuals from the United Kingdom and Germany. Khunti K, Godec, et al. Diabetes Obes Metab. 2017 Aug 17. Early Combination Therapy with Oral Glucose-Lowering Agents in Type 2 Diabetes. Bianchi C, Daniele G, Dardano A, Miccoli R, Del Prato S. Drugs. 2017 Mar;77(3):247-264.

In patients with ASCVD, if therapy does not achieve or maintain the A1C goal over 3-6 months, add agent with evidence of CV risk reduction [currently cana, empa, lira] with consideration of patient factors (Table X). A

General so inclusive of dual, triple, combination therapy. Add text surrounding access to these agents. Add text about other agents in these classes, ongoing studies Include who was at risk of amputation in Cana—absoulte risk. Possible language about maintaining with insulin

A patient-centered approach should be used to guide the choice of pharmacologic agents. Considerations

No change

65

include efficacy, hypoglycemia risk, impact on weight, potential side effects, cost, and patient preferences. E Continuous

reevaluation of medication regimen to incorporate comorbidities, ASCVD, renal, hypoglycemia, age, regimen complexity, and other patient factors is recommended. [Evidence level]

For patients with type 2 diabetes who are not achieving glycemic goals, insulin therapy should not be delayed. B

For patients with type 2 diabetes who are not achieving glycemic goals, intensification, including consideration of insulin therapy,insulin therapy should not be delayed. BA

Few patients achieve and maintain A1c target with monotherapy, in particular those with A1c >9%

Patterns of glycaemic control in patients with type 2 diabetes mellitus initiating second-line therapy after metformin monotherapy: Retrospective data for 10 256 individuals from the United Kingdom and Germany. Khunti K, et al. Diabetes Obes Metab. 2017 Aug 17. Phung OJ, Sobieraj DM, Engel SS, Rajpathak SN. Early combination therapy for the treatment of type 2 diabetes mellitus: systematic review and meta-analysis. Diabetes Obes Metab. 2014;16(5):410–7.

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Early Combination Therapy with Oral Glucose-Lowering Agents in Type 2 Diabetes. Bianchi C, Daniele G, Dardano A, Miccoli R, Del Prato S. Drugs. 2017 Mar;77(3):247-264.

Metformin should be continued as background therapy when used in combination with other agents, including insulin. A

Support?

In patients with long-standing suboptimally controlled type 2 diabetes and established atherosclerotic cardiovascular disease, empagliflozin or liraglutide should be considered as they have been shown to reduce cardiovascular and all-cause mortality when added to standard care. Ongoing studies are investigating the cardiovascular benefits of other agents in these drug classes. B

DeleteIn patients with long-standing suboptimally controlled type 2 diabetes and established atherosclerotic cardiovascular disease, empagliflozin or liraglutide should be considered as they have been shown to reduce cardiovascular and all-cause mortality when added to standard care. Ongoing studies are investigating the cardiovascular benefits of other agents in these drug classes. B

There are now four studies to support this.

Add Canagliflozin study; watch for EASD studies. Any others?

New references

67

not related to a particular recommendation Cardiovascular Disease and Risk Management Hypertension/Blood Pressure Control Blood pressure should be measured at every routine visit. Patients found to have elevated blood pressure should have blood pressure confirmed on a separate day. B

Blood pressure should be measured at every routine clinical visit. Patients found to have elevated blood pressure (> 140/90 mmHg) should have blood pressure confirmed using multiple readings, including measurments on a separate day, to diagnose hypertensionon a separate day. B

Slight update to match 2017 HTN PS Note in text >140 or 90

HTN 1,2,4,5,6,7,8,15,16,24,26 Also, the HTN PS itself should be cited, not sure where/how

All hypertensive

patients with

diabetes should

monitor their blood

pressure at home B

Combining two new recs from 2017 HTN position statement on home BP monitoring (both on home BP, one for diagnosis and one for monitoring) Add specifics about home monitors to text Access/education component in text Include details about why—diagnosis white coat hypertension and promote adherence Go back to Ian about including

HTN 30-34

Most patients with diabetes and

No change HTN 4-8, 40

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hypertension should be treated to a systolic blood pressure goal of < 140 mmHg and a diastolic blood pressure goal of < 90 mmHg. A Lower systolic and diastolic blood pressure targets, such as 130/80 mmHg, may be appropriate for individuals at high risk of cardiovascular disease, if they can be achieved without undue treatment burden. C

No change HTN 18, 19, 41, 43 Cite HTN statement

In pregnant patients with diabetes and chronic hypertension, blood pressure targets of 120–160/80–105 mmHg are suggested in the interest of optimizing long-term maternal health and minimizing impaired fetal growth. E

In pregnant patients with diabetes and preexistingchronic hypertension who are treated with antihypertensive therapy, blood pressure targets of 120–160/80–105 mmHg are suggested in the interest of optimizing long-term maternal health and minimizing impaired fetal growth. E

Slight reword based on 2017 HTN PS Add to text: “Pregnant women with diabetes and pre-existing hypertension or mild gestational hypertension with systolic blood pressure <160 mmHg, diastolic blood pressure <105 mmHg, and no evidence of end-organ damage do not need to be treated with pharmacologic antihypertensive therapy.”

HTN 112,113

Patients with confirmed office-based blood pressure > 140/90 mmHg should, in addition to lifestyle

No change HTN 4-8,40

69

therapy, have prompt initiation and timely titration of pharmacologic therapy to achieve blood pressure goals. A Patients with confirmed office-based blood pressure > 160/100mmHg should, in addition to lifestyle therapy, have prompt initiation and timely titration of two drugs or a single pill combination of drugs demonstrated to reduce cardiovascular events in patients with diabetes. A

No change HTN 62-64

Treatment for hypertension should include drug classes demonstrated to reduce cardiovascular events in patients with diabetes (ACE inhibitors, angiotensin receptor blockers, thiazide- like diuretics, or dihydropyridine calcium channel blockers). Multipledrug therapy is generally

No change HTN 5,65-69,71-72

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required to achieve blood pressure targets (but not a combination of ACE inhibitors and angiotensin receptor blockers). A An ACE inhibitor or angiotensin receptor blocker, at the maximum tolerated dose indicated for blood pressure treatment, is the recommended first-line treatment for hypertension in patients with diabetes and urinary albumin–to–creatinine ratio >300 mg/g creatinine (A) or 30–299 mg/g creatinine (B). If one class is not tolerated, the other should be substituted. B

No change HTN 65,66,75-77,83 also HTN PS itself

For patients treated with an ACE inhibitor, angiotensin receptor blocker, or diuretic, serum creatinine/ estimated glomerular filtration rate and serum potassium levels should be monitored. B

No change HTN 71,72,84,88

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For patients with blood pressure >120/80 mmHg, lifestyle intervention consists of weight loss if overweight or obese; a Dietary Approaches to Stop Hypertension–style dietary pattern including reducing sodium and increasing potassium intake; moderation of alcohol intake; and increased physical activity. B

No change HTN 50-60 Add ACC/AHA 2013 guideline

Patients with hypertension who are not meeting blood pressure targets on three classes of antihypertensive medications including a diuretic should be considered for mineralocorticoid receptor antagonist therapy. B

New rec from 2017 HTN position statement, reworded to clarify conventional treatment and define resistant hypertension Could add to text examples including not tolerating first three drug classes

HTN 105-110

New references not related to a particular recommendation

Lipid Management In adults not taking statins, it is reasonable to obtain a lipid profile at the time of diabetes

No change

72

diagnosis, at an initial medical evaluation, and every 5 years thereafter, or more frequently if indicated. E Obtain a lipid profile at initiation of statin therapy and periodically thereafter as it may help to monitor the response to therapy and inform adherence. E

Obtain a lipid profile at initiation or 4-8 weeks after a change in lipid lowering therapy and annually thereafter to monitor the response to therapy and inform adherence. E

adding more specificity can cite Writing Committee, Lloyd-Jones DM, Morris PB, et al. 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 2016;68:92-125.

Lifestyle modification focusing on weight loss (if indicated); the reduction of saturated fat, trans fat, and cholesterol intake; increase of dietary ω-3 fatty acids, viscous fiber, and plant stanols/sterols intake; and increased physical activity should be recommended to improve the lipid profile in patients with diabetes. A

No change

73

Intensify lifestyle therapy and optimize glycemic control for patients with elevated triglyceride levels (≥150 mg/dL [1.7 mmol/L]) and/or low HDL cholesterol (<40 mg/dL [1.0 mmol/L] for men, <50 mg/dL [1.3 mmol/L] for women). C

No change

For patients with fasting triglyceride levels ≥500 mg/dL (5.7 mmol/L), evaluate for secondary causes of hypertriglyceridemia and consider medical therapy to reduce the risk of pancreatitis. C

No change

For patients of all ages with diabetes and atherosclerotic cardiovascular disease, high-intensity statin therapy should be added to lifestyle therapy. A

No change

For patients with diabetes aged <40 years with additional atherosclerotic cardiovascular disease risk factors, consider using moderate-intensity or high-intensity statin and lifestyle

For patients with diabetes aged <40 years with additional atherosclerotic cardiovascular disease risk factors, the patient and physician provider should discuss recommend

added language on the patient - physician discussion - the patient and physician should discuss using…. Make consistent

2016 ACC Consensus Pathway document (and all guidelines emphasize this)

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therapy. C lifestyle therapy and consider using moderate-intensity or high-intensity statin and lifestyle therapy. C? maybe E

For patients with diabetes aged 40–75 years without additional atherosclerotic cardiovascular disease risk factors, consider using moderate-intensity statin and life-style therapy. A

For patients with diabetes aged >40–75 years (A) and >75 (B) without additional atherosclerotic cardiovascular disease risk factors, use consider using moderate-intensity statin and life-style therapy. A

Change 40-75 to >40 years: There are data in JUPITER and HOPE-3 (and the older CTT) showing benefit of statins in primary prevention in the elderly I verified with Dr. Calhoun, CARDS trial, had no heterogeneity in their elderly (they defined >70) subgroup)

Ridker PM, Lonn E, Paynter NP, Glynn R, Yusuf S. Primary Prevention With Statin Therapy in the Elderly: New Meta-Analyses From the Contemporary JUPITER and HOPE-3 Randomized Trials. Circulation 2017;135:1979-81. CTT 2010 meta-analysis CARDS trial, had no heterogenity in their elderly (they defined >70) subgroup)

For patients with diabetes aged 40–75 years with additional atherosclerotic cardiovascular disease risk factors, consider using high-intensity statin and lifestyle therapy. B

deleteDelete combining those with and without additional risk factors - 1. simplification and 2. will have LDL goals to lead to instensification of therapy if needed

Add supporting evidence from studies in people without diabetes? Cards study—moderate intensity Jupiter study—no diabetes

For patients with diabetes aged >75 years without additional atherosclerotic cardiovascular disease risk factors,

delete Merged with other age group. see above - outcomes similar relative benefit and GREATER absolute benefit in the

75

consider using moderate-intensity statin therapy and lifestyle therapy. B

elderly.

For patients with diabetes aged >75 years with additional atherosclerotic cardiovascular disease risk factors, consider using moderate-intensity or high-intensity statin therapy and lifestyle therapy. B

deletedelete Merged with other age group. see above - outcomes similar relative benefit and GREATER absolute benefit in the elderly.

In clinical practice, providers may need to adjust intensity of statin therapy based on individual patient response to medication (e.g., side effects, tolerability, LDL cholesterol levels). E

In clinical practice, providers may need to adjust intensity of statin therapy based on individual patient response to medication (e.g., side effects, tolerability, LDL cholesterol levels). For patients who do not tolerate the intended intensivity of statin, the maximally tolerated statin dose should be used. E

the term “maximally tolerated statin dose” has emerged in the FDA label for PCKS9 inhibitors, and new consensus statments

2016 ACC document

For ASCVD patients with LDL-C > 70 mg/dl on maximally tolerated statin dose, add ezetimide or PCSK9 inhibitor. A?

New trials of non-statin therapies published after 2013 ACC/AHA guidelineconsensus: IMPROVE IT and FOURIER, showing reduction in CV events with additional lowering of LDL-C, in patients with ASCVD.

Writing Committee, Lloyd-Jones DM, Morris PB, et al. 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic

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Wait for subgroup analysis

(will expand in text) Achieved LDL in the 2 trials of the “very high risk ASCVD” were 54 and 30 mg/dl. Add to text cost issues Revisit when guidelines come out--

Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 2016;68:92-125 EASD study—stay tuned.

delete New trials of non-statin therapies published after 2013 ACC/AHA guideline: IMPROVE IT and FOURIER, showing reduction in CV events with additional lowering of LDL-C, in patients with ASCVD. (will expand in text) Achieved LDL in the 2 trials of the “very high risk ASCVD” were 54 and 30 mg/dl.

Writing Committee, Lloyd-Jones DM, Morris PB, et al. 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 2016;68:92-125

The addition of ezetimibe to moderate-intensity statin therapy has been shown to provide additional cardiovascular benefit compared with moderate-intensity statin therapy alone for patients with recent acute coronary syndrome and LDL cholesterol >50 mg/dL (1.3 mmol/L) and

delete

simplification IMPROVE IT trial (and DM subgroup: RP Giugliano, et al. Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With vs. Without Diabetes: the IMPROVE-IT Trial. abstract ESC 2015. Manuscript submitted and 2016 ACC Expert Consensus Decision Pathway

77

should be considered for these patients A and also in patients with diabetes and history of ASCVD who cannot tolerate high-intensity statin therapy. E FOURIER trial,

and 2016 ACC Expert Consensus Decision Pathway can add RUTHERFORD and FHI and II trials of PCSK9 inhibitors

Combination therapy (statin/fibrate) has not been shown to improve atherosclerotic cardiovascular disease outcomes and is generally not recommended. A However, therapy with statin and fenofibrate may be considered for men with both triglyceride level ≥204 mg/dL (2.3 mmol/L) and HDL cholesterol level <34 mg/dL (0.9 mmol/L). B

Combination therapy (statin/fibrate) has not been shown to improve atherosclerotic cardiovascular disease outcomes and is generally not recommended. A However, therapy with statin and fenofibrate may be considered for men with both triglyceride level 204 mg/dL (2.3 mmol/L) and HDL cholesterol level <34 mg/dL (0.9 mmol/L). B

Move discussion of accord subgroup analysis

Combination therapy (statin/niacin) has not been shown to provide additional cardiovascular benefit above statin

No change

78

therapy alone and may increase the risk of stroke and is not generally recommended. A Statin therapy is contraindicated in pregnancy. B

No change

New references not related to a particular recommendation

Antiplatelet Agents Use aspirin therapy (75–162 mg/day) as a secondary prevention strategy in those with diabetes and a history of atherosclerotic cardiovascular disease. A

No change

For patients with atherosclerotic cardiovascular disease and documented aspirin allergy, clopidogrel (75 mg/day) should be used. B

No change

Dual antiplatelet therapy is reasonable for up to a year after an acute coronary syndrome and may have benefits beyond this period. B

Dual antiplatelet therapy (with low dose aspirin and a P2Y12 inhibitor) is reasonable for up to a year after an acute coronary syndrome and may have benefits beyond this period. B

?? delete - this would be covered in other guidelines.. or add clarification/definition

Consider aspirin therapy (75–162 mg/day) as a primary prevention

No change Aspirin for primary prevention of cardiovascular disease in patients with diabetes: A

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strategy in those with type 1 or type 2 diabetes who are at increased cardiovascular risk. This includes most men or women with diabetes aged ≥50 years who have at least one additional major risk factor (family history of premature atherosclerotic cardiovascular disease, hypertension, dyslipidemia, smoking, or albuminuria) and are not at increased risk of bleeding. C

meta-analysis. Kokoska LA, Wilhelm SM, Garwood CL, Berlie HD. Diabetes Res Clin Pract. 2016 Oct;120:31-9 (NOTE: the results questions the use of ASA for primary prevention in all patients) Aspirin for Primary Prevention. Richman IB, Owens DK. Med Clin North Am. 2017 Jul;101(4):713-724. (NOTE: supports the use of ASA in high CV group)

Aspirin should not be recommended for atherosclerotic cardiovascular disease prevention for adults with diabetes at low atherosclerotic cardiovascular disease risk, such as in men or women with diabetes aged <50 years with no major additional atherosclerotic cardiovascular disease risk factors, as the potential adverse effects from bleeding likely offset the potential benefits. C

deleteGuillermo: Change grade to B Or Delete for simplicity? This is the converse of the prior recommendation.

Guillermo: Several studies showing no benefits in primary prevention but increases risk of GI bleed (JAPAD Trial 2017)

Aspirin for Primary Prevention. Richman IB, Owens DK. Med Clin North Am. 2017 Jul;101(4):713-724. Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: 10-Year Follow-Up of a Randomized Controlled Trial. Saito Y, et al; JPAD Trial Investigators. Circulation. 2017 Feb 14;135(7):659-670.

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When considering aspirin therapy in patients with diabetes < 50 years of age with multiple other Atherosclerotic cardiovascular disease risk factors, clinical judgment is required. E

Delete? Contradicts previous statement. Or Delete for simplicitydelete.

New references not related to a particular recommendation

Management of Atherosclerotic Cardiovascular Disease Risk Factors in the Older Adult Patient With Diabetes. Korytkowski MT, Forman DE. Diabetes Care. 2017 Apr;40(4):476-484. Milionis H, et al. Aspirin Versus Clopidogrel for Type 2 Diabetic Patients with First-Ever Noncardioembolic Acute Ischemic Stroke: Ten-Year Survival Data from the Athens Stroke Outcome Project. J Stroke Cerebrovasc Dis. 2017 Jul 27.

Coronary Heart Disease In asymptomatic patients, routine screening for coronary artery disease is not recommended as it does not improve outcomes as long as atherosclerotic cardiovascular disease risk factors are treated. A

Guillermo: Should we tone down this recommendation? No change

Halon DA, et al. Coronary Computed Tomography (CT) Angiography as a Predictor of Cardiac and Noncardiac Vascular Events in Asymptomatic Type 2 Diabetics: A 7-Year Population-Based Cohort Study. J Am Heart Assoc. 2016 Jun 13;5(6). Results: In subjects with CAC (N=500) independently predicted a CHD event (hazard ratio 3.0, P=0.02). Valenti et al. Absence of Coronary Artery Calcium Identifies Asymptomatic Diabetic Individuals at Low Near-Term But Not Long-Term

81

Risk of Mortality: A 15-Year Follow-Up Study of 9715 Patients. Circ Cardiovasc Imaging. 2016 Feb;9(2):e003528. Summary: CAC may prove useful for identifying diabetic individuals prone to a greater burden of mortality, and may facilitate therapeutic decision-making within a clinical setting.

Consider investigations for coronary artery disease in the presence of any of the following: atypical cardiac symptoms (e.g., unexplained dyspnea, chest discomfort); signs or symptoms of associated vascular disease including carotid bruits, transient ischemic attack, stroke, claudication, or peripheral arterial disease; or electrocardiogram abnormalities (e.g., Q waves). E

Guillermo: Is this needed? No change

In patients with known atherosclerotic cardiovascular disease, use aspirin and statin therapy (if not contraindicated) A

In patients with known atherosclerotic cardiovascular disease, use aspirin and statin therapy (if not contraindicated) A

deleting the ASA and statin - since we have those recommendations above. added ARB - changed strength of evidence to b, since

VALIANT, Telmisartan trials, where ARB is same as ACEi

82

and consider ACE inhibitor therapy C to reduce the risk of cardiovascular events.

and consider ACE inhibitor or ARB therapy C to reduce the risk of cardiovascular events.B

there are multiple trials of ACE inhbition for primary prevention each with a DM subgroup

In patients with prior myocardial infarction, β-blockers should be continued for at least 2 years after the event. B

No change Personally, i wouldn't rush to stop these at 2 years.

In patients with symptomatic heart failure, thiazolidinedione treatment should not be used. A

Delete? ? delete and merge that into the overall choices of Rx section?

In patients with type 2 diabetes with stable congestive heart failure, metformin may be used if estimatedglomerular filtration remains > 30 mL/min but should be temporarily avoided in unstable or hospitalized patients with congestive heart failure. B

No changeMove to chapter 14

? merge with choice of agent section by patient characteristics.

Repeat ASCVD recommendation from glycemic section here.

EMPA-REG, CANVAS,, and LEADER:

(and add brief support in text from SUSTAIN)

Delete

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. Zinman B, etal. N Engl J Med. 2015 Nov

83

26;373(22):2117-28 Canvas. NEJM Kosiborod M, et al. Lower Risk of Heart Failure and Death in Patients Initiated on Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL Study (Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors). Circulation. 2017 Jul 18;136(3):249-259.

New references not related to a particular recommendation

Cardiovascular mortality and morbidity in patients with type 2 diabetes following initiation of sodium-glucose co-transporter-2 inhibitors versus other glucose-lowering drugs (CVD-REAL Nordic): a multinational observational analysis. Birkeland KI, Jørgensen ME, Carstensen B, Persson F, Gulseth HL, Thuresson M, Fenici P, Nathanson D, Nyström T, Eriksson JW, Bodegård J, Norhammar A. Lancet Diabetes Endocrinol. 2017 Aug 3.

Mirovascular Complications and Foot Care Diabetic Kidney Disease At least once a year, assess urinary albumin (e.g., spot urinary albumin–to– creatinine ratio) and estimated glomerular filtration rate in patients with type 1 diabetes with duration of ≥5 years, in all patients

No change

84

with type 2 diabetes, and in all patients with comorbid hypertension. B Optimize glucose control to reduce the risk or slow the progression of diabetic kidney disease. A

No change

Optimize blood pressure control to reduce the risk or slow the progression of diabetic kidney disease. A

No change

BP and Renal Outcomes in Diabetic Kidney Disease: The Veterans Affairs Nephropathy in Diabetes Trial. Leehey DJ, Zhang JH, Emanuele NV, Whaley-Connell A, Palevsky PM, Reilly RF, Guarino P, Fried LF; VA NEPHRON-D Study Group. Clin J Am Soc Nephrol. 2015 Dec 7;10(12):2159-69.

For people with nondialysis-dependent diabetic kidney disease, dietary protein intake should be approximately 0.8 g/kg body weight per day (the recommended daily allowance). For patients on dialysis, higher levels of dietary protein intake should be considered. B

No change

For patients with mild-moderate CKD, consider

Based on EMPA-REG, CANVAS, SUSTAIN, and LEADER: CVD benefits

85

including an agent with evidence for CV benefits GLP-1 agonist or SGLT2 inhibitoand demonstrated to reduce kidney diseaser demonstrated to reduce cardiovascular risk and risk in the regimen for glycemic control. B or C

extend to DKD subgroups, and each agent had beneficial effects on (secondary) renal outcomes

In nonpregnant patients with diabetes and hypertension, either an ACE inhibitor or an angiotensin receptor blocker is recommended for those with modestly elevated urinary albumin–to–creatinine ratio (30–299 mg/g creatinine) B and is strongly recommended for those with urinary albumin–to–creatinine ratio>300 mg/g creatinine and/or estimated glomerular filtration rate < 60 mL/min/1.73 m2. A

No change

Periodically monitor serum creatinine and

Delete (Guillermo) Or increase level of

New data on high incidence of hyperkalemia and AKI

I will list these...

86

potassium levels for the development of increased creatinine or changes in potassium when ACE inhibitors, angiotensin receptor blockers, or diuretics are used. E

evidence to B and associations of those occurrences with subsequent poor outcomes

Continued monitoring of urinary albumin–to–creatinine ratio in patients with albuminuria treated with an ACE inhibitor or an angiotensin receptor blocker is reasonable to assess the response to treatment and progression of diabetic kidney disease. E

Delete?

An ACE inhibitor or an angiotensin receptor blocker is not recommended for the primary prevention of diabetic kidney disease in patients with diabetes who have normal blood pressure, normal urinary albumin–to–creatinine ratio (<30 mg/g), and normal estimated glomerular filtration rate. B

No change

When estimated glomerular

Delete (too many)? (Guillermo)

87

filtration rate is <60 mL/min/1.73 m2, evaluate and manage potential complications of chronic kidney disease. E

Or No change

Patients should be referred for evaluation for renal replacement treatment if they have estimated glomerular filtration rate <30 mL/min/1.73 m2. A

No change

Promptly refer to a physician experienced in the care of kidney disease for uncertainty about the etiology of kidney disease, difficult management issues, and rapidly progressing kidney disease. B

No change

Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. N Engl J Med. 2016 Jul 28;375(4):323-34. Canagliflozin Slows Progression of Renal Function Decline

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Independently of Glycemic Effects. Heerspink HJ, Desai M, Jardine M, Balis D, Meininger G, Perkovic V. J Am Soc Nephrol. 2017 Jan;28(1):368-375

New references not related to a particular recommendation

Diabetic Retinopathy Optimize glycemic control to reduce the risk or slow the progression of diabetic retinopathy. A

No change

Optimize blood pressure and serum lipid control to reduce the risk or slow the progression of diabetic retinopathy. A

No change

Adults with type 1 diabetes should have an initial dilated and comprehensive eye examination by an ophthalmologist or optometrist within 5 years after the onset of diabetes. B

No change Frequency of Evidence-Based Screening for Retinopathy in Type 1 Diabetes. DCCT/EDIC Research Group, Nathan DM, Bebu I, Hainsworth D, Klein R, Tamborlane W, Lorenzi G, Gubitosi-Klug R, Lachin JM. N Engl J Med. 2017 Apr 20;376(16):1507-1516.

Patients with type 2 diabetes should have an initial dilated and comprehensive eye examination by an ophthalmologist or

No change

89

optometrist at the time of the diabetes diagnosis. B If there is no evidence of retinopathy for one or more annual eye exams and glycemia is well controlled, then exams every 2 years may be considered. If any level of diabetic retinopathy is present, subsequent dilated retinal examinations should be repeated at least annually by an ophthalmologist or optometrist. If retinopathy is progressing or sight-threatening, then examinations will be required more frequently. B

No change Add this reference in the text:

https://www.ncbi.nlm.nih.gov/pubmed/28423305

While retinal photography may serve as a screening tool for retinopathy, it is not a substitute for a comprehensive eye exam. E

Guillermo: Is this true? It is good foo screening. Need to refer patients with normal fundus photography? No change

although the nejm study used retinal photography: https://www.ncbi.nlm.nih.gov/pubmed/28423305

Women with preexisting type 1 or type 2 diabetes who are planning pregnancy or who are pregnant should be counseled on the risk of development and/or progression of

No change

90

diabetic retinopathy. B Eye examinations should occur before pregnancy or in the first trimester in patients with preexisting type 1 or type 2 diabetes, and then patients should be monitored every trimester and for 1 year postpartum as indicated by the degree of retinopathy. B

No change

Promptly refer patients with any level of macular edema, severe nonproliferative diabetic retinopathy (a precursor of proliferative diabetic retinopathy), or any proliferative diabetic retinopathy to an ophthalmologist who is knowledgeable and experienced in the management and treatment of diabetic retinopathy. A

No change

Laser photocoagulation therapy is indicated to reduce the risk of vision loss in patients with high-risk proliferative diabetic retinopathy

Guillermo: Not sure this is the treatment of choice anymore.

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and, in some cases, severe nonproliferative diabetic retinopathy. A Intravitreal injections of antivascular endothelial growth factor are indicated for central-involved diabetic macular edema, which occurs beneath the foveal center and may threaten reading vision. A

Guillermo: Need to be changed significantly. In eyes with PDR, ranibizumab resulted in less PDR worsening compared with PRP, especially in eyes not required to receive ranibizumab for center-involved DME

Large number of RCT have shown superiority of injections vs photocoagulation. Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Patient-Centered Outcomes From a Randomized Clinical Trial. Beaulieu WT, Bressler NM, Melia M, Owsley C, Mein CE, Gross JG, Jampol LM, Glassman AR; Diabetic Retinopathy Clinical Research Network. Am J Ophthalmol. 2016 Oct;170:206-213. Factors Associated with Worsening Proliferative Diabetic Retinopathy in Eyes Treated with Panretinal Photocoagulation or Ranibizumab. Bressler SB, Beaulieu WT, Glassman AR, Gross JG, Jampol LM, Melia M, Peters MA, Rauser ME; Diabetic Retinopathy Clinical Research Network. Ophthalmology. 2017 Apr;124(4):431-439.

*first vegf inhibitor FDA approved for DR https://www.gene.com/media/press-releases/14661/2017-04-17/fda-approves-genentechs-lucentis-ranibiz Change in Diabetic Retinopathy Through 2 Years: Secondary Analysis of a Randomized Clinical Trial Comparing Aflibercept, Bevacizumab, and Ranibizumab. Bressler SB, Liu D, Glassman AR, Blodi BA, Castellarin AA, Jampol LM, Kaufman PL, Melia M, Singh H, Wells JA; Diabetic Retinopathy Clinical Research Network. JAMA Ophthalmol. 2017 Jun 1;135(6):558-568.

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The presence of retinopathy is not a contraindication to aspirin therapy for cardioprotection, as aspirin does not increase the risk of retinal hemorrhage. A

No change

New references not related to a particular recommendation

semaglutide worsens retinopathy: **need to see if other GLP-1 agonists have similar effect in recent RCTs**: https://www.ncbi.nlm.nih.gov/pubmed/27633186 interesting study with PUFAs but don’t necessarily need to include: https://www.ncbi.nlm.nih.gov/pubmed/27541690 retinal changes already present in prediabetes: https://www.ncbi.nlm.nih.gov/pubmed/27678264 need for youth to be screened: https://www.ncbi.nlm.nih.gov/pubmed/28245334 new fda drug approved for DR: https://www.gene.com/media/press-releases/14661/2017-04-17/fda-approves-genentechs-lucentis-ranibiz

Neuropathy All patients should be assessed for diabetic peripheral neuropathy starting at diagnosis of type 2 diabetes and 5 years after the diagnosis of type 1 diabetes and at least annually thereafter. B

No change

Assessment for distal symmetric polyneuropathy should include a careful history and assessment of either temperature or pinprick sensation (small-fiber function) and

No change

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vibration sensation using a 128-Hz tuning fork (for large-fiber function). All patients should have annual 10-g monofilament testing to identify feet at risk for ulceration and amputation. B Symptoms and signs of autonomic neuropathy should be assessed in patients with microvascular and neuropathic complications. E

No change

Optimize glucose control to prevent or delay the development of neuropathy in patients with type 1 diabetes A and to slow the progression of neuropathy in patients with type 2 diabetes. B

No change

Assess and treat patients to reduce pain related to diabetic peripheral neuropathy B and symptoms of autonomic neuropathy and to improve quality of life. E

No change Add PMID 28341643

Either pregabalin or duloxetine are recommended as initial

No change Add PMID 28341643

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pharmacologic treatments for neuropathic pain in diabetes. A New references not related to a particular recommendation

Foot Care Perform a comprehensive foot evaluation at least annually to identify risk factors for ulcers and amputations. B

No change

All patients with diabetes should have their feet inspected at every visit. C

No change

Obtain a prior history of ulceration, amputation, Charcot foot, angioplasty or vascular surgery, cigarette smoking, retinopathy, and renal disease and assess current symptoms of neuropathy (pain, burning, numbness) and vascular disease (leg fatigue, claudication). B

No change

The examination should include inspection of the skin, assessment of foot deformities, neurological assessment (10-g monofilament

No change

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testing with at least one other assessment: pinprick, temperature, vibration, or ankle reflexes), and vascular assessment including pulses in the legs and feet. B Patients with symptoms of claudication or decreased or absent pedal pulses should be referred for ankle-brachial index and for further vascular assessment as appropriate. C

No change

A multidisciplinary approach is recommended for individuals with foot ulcers and high-risk feet (e.g., dialysis patients and those with Charcot foot, prior ulcers, or amputation). B

No change **we don’t actually talk about the need for wound care in any of these recommendations but the evidence to date seems poor quality: https://www.ncbi.nlm.nih.gov/pubmed/27556756

Refer patients who smoke or who have histories of prior lower-extremity complications, loss of protective sensation, structural abnormalities, or peripheral arterial disease to foot care specialists for ongoing preventive care and lifelong surveillance. C

No change

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Provide general foot self-care education to all patients with diabetes. B

No change

The use specialized therapeutic footwear is recommended for high-risk patients with diabetes including those with severe neuropathy, foot deformities, or history of amputation. B

The use of specialized therapeutic footwear is recommended for high-risk patients with diabetes including those with severe neuropathy, foot deformities, or history of amputation. B

New references not related to a particular recommendation

need for more evidence on how to appropriately dress DFU: https://www.ncbi.nlm.nih.gov/pubmed/27556756 hyperbaric oxygen:

1) no effect on qol: https://www.ncbi.nlm.nih.gov/pubmed/28603808 2) cochorane review on need for more evidence:

https://www.ncbi.nlm.nih.gov/pubmed/26106870 3) andrew boulton chapter:

https://www.ncbi.nlm.nih.gov/pubmed/28121117 low to moderate evidence in meta-analysis to enhance dfu healing and prevent amputation:: https://www.ncbi.nlm.nih.gov/pubmed/26804368

Older Adults Consider the assessment of medical, mental, functional, and social geriatric domains in older adults to provide a framework to determine targets and therapeutic approaches for diabetes management. C

Consider the assessment of medical,psychological mental, functional, and social geriatric domains in older adults to provide a framework to determine targets and therapeutic approaches for diabetes management. C

-“mental” does not seem like a medical term

- either can be “psychological” or “cognitive function and depression”

N/A

Screening for geriatric syndromes

No change

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may be appropriate in older adults experiencing limitations in their basic and instrumental activities of daily living, as they may affect diabetes self-management and be related to health-related quality of life. C Annual screening for early detection of mild cognitive impairment or dementia is indicated for adults 65 years of age or older. B

Annual sScreening for early detection of mild cognitive impairment or dementia, and depression is indicated for adults 65 years of age or older at initial visit and when there is a change in disease, treatment, or life circumstances including caregivers and family members. B

Language from psychosocial paper- general recommendation – evidence does not support annual screening in consensus report. The reference cited “15” – recommends as follows_ see footnote 1.

Psychosocial position statement Diabetes Care 2012 Dec; 35(12): 2650-2664. https://doi.org/10.2337/dc12-1801 https://www.nap.edu/read/21693/chapter/1#v

Older adults (≥65 years of age) with diabetes should be considered a high-priority population for depression screening and treatment. B

May remove mention of “depression” separately, if it is added to the bullet above.Delete

? Need to be highlighted although, geriatric syndrome includes everything.

Hypoglycemia should be avoided in older adults with diabetes. It should be assessed and managed by adjusting glycemic

No change Move to “hypoglycemia” subtitle

Easier to read N/A

98

targets and pharmacologic interventions. B Medical conditions

that interfere with RBC life-span and RBC turnover such as anemia, renal insufficiency, acute illnesses, and use of medications such as erythropoietin are common in older adults. A1C should be used as a marker of glycemic control in context of other conditions in this population. Finger stick readings should be used to assess glycemic control if A1C is deemed not useful. B

In light of recent focus on “beyond A1C”, this point (although not a new information) should be highlighted. For monitoring

Ref – Standard of care 2009 “limitations of A1c”

Treatment Goals Older adults who are cognitively and functionally intact and have significant life expectancy may receive diabetes care with goals similar to those developed for younger adults. C

Older adult with few comorbidities, intact cognitive function, and functional independence should have lower glycemic goals, while those with multiple comorbidities, cognitive dysfunction, or functional

To provide clarity about the entire heterogeneous population of older adults

Diabetes Care 2012 Dec; 35(12): 2650-2664. https://doi.org/10.2337/dc12-1801

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dependence should have liberal less stringent glycemic goals. C

Glycemic goals for some older adults might reasonably be relaxed, using individual criteria, but hyperglycemia leading to symptoms or risk of acute hyperglycemic complications should be avoided in all patients. C

No change

Screening for diabetes complications should be individualized in older adults. Particular attention should be paid to complications that would lead to functional impairment. C

No change

Treatment of hypertension to individualized target levels is indicated in most older adults. C

No change

Treatment of other cardiovascular risk factors should be individualized in older adults considering the time frame of benefit. Lipid-lowering therapy and aspirin therapy may benefit those

No change

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with life expectancies at least equal to the time frame of primary prevention or secondary intervention trials. E Add recommendations at the top of subsection „Pharmacologic therapy“

These are important points already mentioned in the text. They should be highlighted as recommendations.

Metformin can be used safely in older adults with eGFR≥ 30 ml/min/1.73 m2. B

Moved from text Include? Dose should be half the maximum in patients with eGFR between 30-60 ml/min/1.73 m2

N/A

In older adults at increased risk of hypoglycemia, classes of medications with low risk of hypoglycemia are preferred. B

Moved from text

N/A

Overtreatment of diabetes is common in older adults and should be avoided. B

Emerging concept – discussed at ADA in several symposia Define overtreatment in text

Diabetes Care 2015;38:588–595 | DOI: 10.2337/dc14-0599 JAMA Intern Med. 2015;175(3):356-362. doi:10.1001/jamainternmed.2014.7345 Overtreatment-- Norway Andreassen et al. Nursing home patients with diabetes: prevalence, drug treatment and

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glycemic control. Diabetes Res Clin Pract. 2014 Jul;105(1):102-9.

Simplification (de-intensification) of complex regimen is recommended to reduce risk of hypoglycemia, if it can achieve appropriate glycemic target. B

Important concept in geriatric medicine with more data to support in diabetes

JAMA Intern Med. 2015;175(12):1942-1949. doi:10.1001/jamainternmed.2015.5110

Qual Outcomes. 2017;10:e003514. DOI: 10.1161/CIRCOUTCOMES.116.003514

PMID: 27273335 DOI:10.1001/jamainternmed.2016.2288

Treatment in skilled nursing facilities and nursing homes Consider diabetes education for the staff of long-term care facilities to improve the management of older adults with diabetes. E

No change

Patients with diabetes residing in long-term care facilities need careful assessment to establish glycemic goals and to make appropriate choices of glucose-lowering agents based on their clinical and functional status. E

No change 1) Evidence of overtreatment in nursing home

2) High rate of hypoglycemia in insulin and non-insulin treated patients in a RCT.

3) Use of agents with low-risk of hypoglycemia may be preferable as initial treatment of most patients with T2D in

Andreassen et al. Nursing home patients with diabetes: prevalence, drug treatment and glycemic control. Diabetes Res Clin Pract. 2014 Jul;105(1):102-9.

Findings: Mean HbA1c was 7.3% (57 mmol/mol), 46% of patients had an HbA1c <7.0% (53 mmol/mol), and CBGM consistent with risk of

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LTC settings hypoglycemia was found for 60% of these patients.) 2) Pasquel et al. A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities. BMJ Open Diabetes Res Care. 2015 Aug 28;3(1):e000104. Findings: rate of hypoglycemia (<70 mg/dL) in insulin (27%) and OAD (31%) treated groups

3) Umpierrez et al. A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients with Type 2 Diabetes in Long-Term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial. Diabetes care Under Review. Presented at ADA 2017 meeting

End-of-Life Care When palliative care is needed in older adults with diabetes, strict blood pressure control may not be necessary, and withdrawal of therapy may be appropriate. Similarly, the intensity of lipid management can be relaxed, and

No change Move to End-of-Life Care

Easier to read N/A

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withdrawal of lipid-lowering therapy may be appropriate. E Overall comfort, prevention of distressing symptoms, and preservation of quality of life and dignity are primary goals for diabetes management at the end of life. E

No Change

New references not related to a particular recommendation

BMJ Open Diabetes Res Care. 2015 Aug 28;3(1):e000104. doi: 10.1136/bmjdrc-2015-000104. eCollection 2015

Umpierrez et al. A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients with Type 2 Diabetes in Long-Term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial. Diabetes care Under Review. Presented at ADA 2017 meeting

Children and Adolescents Diabetes Self-management Education and Support Youth with type 1 diabetes and parents/caregivers (for patients aged <18 years) should receive culturally sensitive and developmentally appropriate individualized diabetes self-management education and support according to national standards at diagnosis and routinely thereafter. B

No change

New references not related to a particular recommendation

Beck RW, Riddlesworth T, Ruedy K, et al; DIAMOND Study Group. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: the DIAMOND

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randomized clinical trial. JAMA. 2017 Jan 24;317(4):371-378

Lind M, Polonsky W, Hirsch IB, et al. Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: the GOLD randomized clinical trial. JAMA. 2017 Jan 24;317(4):379-387

Psychosocial Issues At diagnosis and during routine follow-up care, assess psychosocial issues and family stresses that could impact adherence to diabetes management and provide appropriate referrals to trained mental health professionals, preferably experienced in childhood diabetes. E

No change

Mental health professionals should be considered integral members of the pediatric diabetes multidisciplinary team. E

No change

Encourage developmentally appropriate family involvement in diabetes management tasks for children and adolescents, recognizing that premature transfer

Evidence level in position statement A

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of diabetes care to the child can result in nonadherence and deterioration in glycemic control. B Providers should assess children’s and adolescents’ diabetes distress, social adjustment (peer relationships), and school performance to determine whether further intervention is needed. B

Providers should assess children’s and adolescents’consider asking youth and their parents about diabetes distress, social adjustment (peer relationships), and school performance to determine whether further intervention is needed. B

Re-phrasing to be consistent with new PS

Helgeson VS, Palladino DK. Implications of Psychosocial Factors for Diabetes Outcomes among Children with Type 1 Diabetes: A Review. Soc Personal Psychol Compass. 2012 Mar 1;6(3):228–42.

Assess youth with diabetes for generic and diabetes-related distress, generally starting at 7-8 years of age. B

Mention a validated tool in text

Hagger V, Hendrieckx C, Sturt J, Skinner TC, Speight J. Diabetes Distress Among Adolescents with Type 1 Diabetes: a Systematic Anderson BJ, Laffel LM, Domenger C, Danne T, Phillip M, Mazza C, et al. Factors Associated With Diabetes-Specific Health-Related Quality of Life in Youth With Type 1 Diabetes: The Global TEENs Study. Diabetes Care. 2017 May 22;dc161990.

In youth and families with behavioral self-care difficulties, repeated hospitalizations for diabetic ketoacidosis, or

At diagnosis and during routine follow-up care, consider assessing psychosocial issues and family stresses that could impact diabetes

Re-phrasing to be consistent with new PS. More expansive assessment.

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significant distress, consider referral to a mental health provider for evaluation and treatment. E

management and provide appropriate referrals to trained mental health professionals, preferably experienced in childhood diabetes. E

Adolescents should have time by themselves with their care provider(s) starting at age 12 years. E

Offer Aadolescents should have time by themselves with their care provider(s) starting at age 12 years, or when developmentally appropriate. E

Re-phrasing to be consistent with new PS.

Starting at puberty, preconception counseling should be incorporated into routine diabetes care for all girls of childbearing potential. A

No change

New references not related to a particular recommendation

Young-Hyman D, Groot M de, Hill-Briggs F, Gonzalez JS, Hood K, Peyrot M. Psychosocial Care for People With Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Dec 1;39(12):2126–40.

Glycemic Control The majority of

children with type 1 diabetes should be treated with intensive insulin regimens, either via multiple daily injections or CSII. A

Current glycemic control section does not emphasize this. Keeping consistent with new Position statement.

Give DCCT NEJM 93 as support

All children and adolescents with type 1 diabetes should have blood glucose levels

Current glycemic control section does not emphasize this. Keeping consistent with new Position

37. Levine BS, Anderson BJ, Butler DA, Antisdel JE, Brackett J, Laffel LM. Predictors of glycemic control and

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monitored multiple times daily, including pre-meal, pre-bedtime, and as needed for safety in specific clinical situations such as exercise, driving, or for symptoms of hypoglycemia B.

statement. short-term adverse outcomes in youth with type 1 diabetes. J Pediatr. 2001 Aug;139(2):197–203. 38. Miller KM, Beck RW, Bergenstal RM, Goland RS, Haller MJ, McGill JB, et al. Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants. Diabetes Care. 2013 Jul;36(7):2009–14.

Continuous glucose monitoring should be considered in children and adolescents with type 1 diabetes, whether using injections or CSII, as an additional tool to help improve glycemic control. Benefits of CGM correlate with adherence to ongoing use of the device. B

Current glycemic control section does not emphasize this. Keeping consistent with new Position statement.

33. Slover RH, Welsh JB, Criego A, Weinzimer SA, Willi SM, Wood MA, et al. Effectiveness of sensor-augmented pump therapy in children and adolescents with type 1 diabetes in the STAR 3 study. Pediatr Diabetes. 2012 Feb;13(1):6–11. 42. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, et al. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464–76. 43. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Beck RW, Buckingham B,

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Miller K, Wolpert H, Xing D, et al. Factors predictive of use and of benefit from continuous glucose monitoring in type 1 diabetes. Diabetes Care. 2009 Nov;32(11):1947–53. 44. Chase HP, Beck RW, Xing D, Tamborlane WV, Coffey J, Fox LA, et al. Continuous glucose monitoring in youth with type 1 diabetes: 12-month follow-up of the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized trial. Diabetes Technol Ther. 2010 Jul;12(7):507–15. 45. Mauras N, Beck R, Xing D, Ruedy K, Buckingham B, Tansey M, et al. A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years. Diabetes Care. 2012 Feb;35(2):204–10. 46. Tsalikian E, Fox L, Weinzimer S, Buckingham B, White NH, Beck R, et al. Feasibility of prolonged continuous glucose monitoring in toddlers with type 1 diabetes. Pediatr Diabetes. 2012 Jun;13(4):301–7. 47. Miller KM, Foster NC, Desalvo D, DiMeglio

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LA, Laffel LM, Tamborlane WV. Poster: Continuous glucose monitoring (CGM) use in type 1 diabetes: an update from the T1D Exchange Clinic Registry. Pediatr Diabetes. 17(Supp24):49. 48. Laffel L. Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. Diabetes Technol Ther. 2016 Feb;18 Suppl 2:S223-233. 49. Foster NC, Miller KM, Tamborlane WV, Bergenstal RM, Beck RW, T1D Exchange Clinic Network. Continuous Glucose Monitoring in Patients With Type 1 Diabetes Using Insulin Injections. Diabetes Care. 2016 Jun;39(6):e81-82.

Automated insulin delivery systems improve glycemic control and reduce hypoglycemia in adolescents and should be considered in adolescents with type 1 diabetes B

Current glycemic control section does not emphasize this. Keeping consistent with new Position statement. Apply to adults?

50. Bergenstal RM, Klonoff DC, Garg SK, Bode BW, Meredith M, Slover RH, et al. Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia. N Engl J Med. 2013;369(3):224–32. 51. Abraham MB, Davey R, O’Grady MJ, Ly TT, Paramalingam N, Fournier PA, et al. Effectiveness of a Predictive Algorithm in the Prevention of Exercise-Induced Hypoglycemia in Type 1

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Diabetes. Diabetes Technol Ther. 2016 Sep;18(9):543–50. 52. Buckingham BA, Bailey TS, Christiansen M, Garg S, Weinzimer S, Bode B, et al. Evaluation of a Predictive Low-Glucose Management System In-Clinic. Diabetes Technol Ther. 2017 May;19(5):288–92. 53. Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, et al. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025–32. 54. Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, et al. Home Use of an Artificial Beta Cell in Type 1 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2129–40. 55. Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, et al. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407–8. 56. Kovatchev B, Cheng P, Anderson SM, Pinsker JE, Boscari F, Buckingham BA, et al. Feasibility of Long-Term Closed-Loop Control: A

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Multicenter 6-Month Trial of 24/7 Automated Insulin Delivery. Diabetes Technol Ther. 2017 Jan;19(1):18–24. 57. El-Khatib FH, Balliro C, Hillard MA, Magyar KL, Ekhlaspour L, Sinha M, et al. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet Lond Engl. 2017 Jan 28;389(10067):369–80.

An A1C goal of <7.5% (58 mmol/mol) is recommended across all pediatric age-groups. E

No change Consistent with new T1D position statement.

New references not related to a particular recommendation

Autoimmune Conditions Assess for the presence of autoimmune conditions associated with type 1 diabetes soon after the diagnosis and if symptoms develop. EB

Guillermo: Change to A B level evidence Or No change (Maahs)

Hughes JW1, et al. J Clin Endocrinol Metab. 2016 Dec;101(12):4931-4937. Autoimmune Diseases in Children and Adults With Type 1 Diabetes From the T1D Exchange Clinic Registry. Kahaly GJ and Hansen MP. Autoimmun Rev. 2016 Jul;15(7):644-8. Type 1 diabetes associated autoimmunity. Diabetes Care. 2017 Aug;40(8):1034-1040. doi: 10.2337/dc16-2508.

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Epub 2017 May 25. Prevalence of Celiac Disease in 52,721 Youth With Type 1 Diabetes: International Comparison Across Three Continents

Consider testing individuals with type 1 diabetes for antithyroid peroxidase and antithyroglobulin antibodies soon after the diagnosis. E

No change

Measure thyroid-stimulating hormone concentrations soon after the diagnosis of type 1 diabetes and after glucose control has been established. If normal, consider rechecking every 1–2 years or sooner if the patient develops symptoms suggestive of thyroid dysfunction, thyromegaly, an abnormal growth rate, or an unexplained glycemic variation. E

Measure thyroid-stimulating hormone concentrations at diagnosis when clinically stable or soon after the diagnosis of type 1 diabetesglycemic control has been established and after glucose control has been established. If normal, consider rechecking every 1–2 years or sooner if the patient develops symptoms suggestive of thyroid dysfunction, thyromegaly, an abnormal growth rate, or an unexplained glycemic variation. EB

Guillermo: Checking for TSH is grade A (tons of evidence) The rest is C or E Maahs: Re-wording consistent with new Position statement

Evidence Guillermo? J Clin Endocrinol Metab. 2017 Apr 1;102(4):1277-1285. doi: 10.1210/jc.2016-2335.

Thyroid and Islet Autoantibodies Predict Autoimmune Thyroid Disease at Type 1 Diabetes Diagnosis.

Jonsdottir B1, Larsson C2, Carlsson A3, Forsander G4, Ivarsson SA1, Lernmark Å1, Ludvigsson J5, Marcus C6, Samuelsson U5, Örtqvist E7, Larsson HE1; Better Diabetes Diagnosis Study Group

In this study TPOAb was much stronger than TGAb, but perhaps we keep as is with both as

113

considerations.

Add “ For thyroid antibodies, a recent study from Sweden indicated TPOAb was more predictive than TGAb in multivariate analysis (159).”

Consider screening children with type 1 diabetes for celiac disease by measuring either tissue transglutaminase or deamidated gliadin antibodies, with documentation of normal total serum IgA levels, soon after the diagnosis of diabetes. E

Consider screening Screen children with type 1 diabetes for celiac disease by measuring either tissue transglutaminase or deamidated gliadin antibodies, with documentation of normal total serum IgA levels, soon after the diagnosis of diabetes, or IgG to tissure transglutamine and deamidated gliadin antibodies if IgA deficient. EB

Re-wording consistent with new Position statement.

Change evidence level to B?

Hughes JW1, et al. J Clin Endocrinol Metab. 2016 Dec;101(12):4931-4937. Autoimmune Diseases in Children and Adults With Type 1 Diabetes From the T1D Exchange Clinic Registry.

Kahaly GJ and Hansen MP. Autoimmun Rev. 2016 Jul;15(7):644-8. Type 1 diabetes associated autoimmunity.

Diabetes Care. 2017 Aug;40(8):1034-1040. doi: 10.2337/dc16-2508. Epub 2017 May 25.

Prevalence of Celiac Disease in 52,721 Youth With Type 1 Diabetes: International Comparison Across Three Continents Prevalence of Celiac Disease in 52,721 Youth With Type 1 Diabetes:

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International Comparison Across Three Continents. Craig ME, Australasian Diabetes Data Network (ADDN); T1D Exchange Clinic Network (T1DX); National Paediatric Diabetes Audit (NPDA) and the Royal College of Paediatrics and Child Health; Prospective Diabetes Follow-up Registry (DPV) initiative. Diabetes Care. 2017 Aug;40(8):1034-1040. Pham-Short A et al. Pediatrics. 2015 Jul;136(1):e170-6. Screening for Celiac Disease in Type 1 Diabetes: A Systematic Review.

Consider screening in children who have a first-degree relative with celiac disease, growth failure, weight loss, failure to gain weight, diarrhea, flatulence, abdominal pain, or signs of malabsorption or in individuals with frequent unexplained hypoglycemia or deterioration in glycemic control. E

Repeat screening within 2 and then again 5 years thereafter and consider more frequent screening in children who have symptoms or a first-degree relative with celiac disease. B

Re-wording consistent with new Position statement.

Change evidence level to B?

Pham-Short A et al. Pediatrics. 2015 Jul;136(1):e170-6. Screening for Celiac Disease in Type 1 Diabetes: A Systematic Review.

Individuals with biopsy-confirmed celiac disease

Individuals Children with biopsy-confirmed

Re-wording consistent with new Position statement

115

should be placed on a gluten-free diet and have a consultation with a dietitian experienced in managing both diabetes and celiac disease. B

celiac disease should be placed on a gluten-free diet and have a consultation with a dietitian experienced in managing both diabetes and celiac disease. B

New references not related to a particular recommendation

Benefits of a gluten-free diet for asymptomatic patients with serologic markers of celiac disease. Kurppa K, Paavola A, Collin P, Sievänen H, Laurila K, Huhtala H, Saavalainen P, Mäki M, Kaukinen K. Gastroenterology. 2014 Sep;147(3):610-617.e1

Management of Cardiovascular Risk Factors Blood pressure should be measured at each routine visit. Children found to have high-normal blood pressure (systolic blood pressure or diastolic blood pressure >90th percentile for age, sex, and height) or hypertension (systolic blood pressure or diastolic blood pressure >95th percentile for age, sex, and height) should have elevated blood pressure confirmed on 3 separate days. B

No change

Initial treatment of high-normal blood pressure (systolic blood pressure or

No change

116

diastolic blood pressure consistently ≥90th percentile for age, sex, and height) includes dietary modification and increased exercise, if appropriate, aimed at weight control. If target blood pressure is not reached with 3–6 months of initiating lifestyle intervention, pharmacologic treatment should be considered. E In addition to lifestyle modification, pharmacological treatment of hypertension (systolic blood pressure or diastolic blood pressure consistently ≥95th percentile for age, sex, and height) should be considered as soon as hypertension is confirmed. E

No change

ACE inhibitors or angiotensin recep tor blockers should be considered forthe initial pharmacologic treatment of hypertension, following reproductive

ACE inhibitors or angiotensin recep tor blockers should be considered forthe initial pharmacologic treatment of hypertensionfor the treatment of ACR

Potential benefits for hypertension

Dunger NEJM ’17 in press. Presented at ADA Today SEARCH

117

counseling and implementation of effective birth control due to the potential teratogenic effects of both drug classes. E

in, A or B, and hypertension (E) in children and adolescents, following reproductive counseling and implementation of effective birth control due to the potential teratogenic effects of both drug classes. E

I suggest we elevate the level of evidence for this based on AdDIT to ‘A’. RCT of ACEi v placebo.

Caveat to this is that the ACE was prescribed for ACR elevation, not BP per se, although it had a beneficial effect on BP as I understand it from Dunger’s talk

The goal of treatment is blood pressure consistently <90th percentile for age, sex, and height. E

No change

Obtain a fasting lipid profile in children ≥10 years of age soon after the diagnosis (after

Obtain a fasting lipid profile in children ≥10 years of age soon after the diagnosis (after

Consistency with PS

118

glucose control has been established). E

glucose control has been established). If abnormal repeat labs fasting E

If lipids are abnormal, annual monitoring is reasonable. If LDL cholesterol values are within the accepted risk level (<100 mg/dL [2.6 mmol/L]), a lipid profile repeated every 3–5 years is reasonable. E

No change

Initial therapy should consist of optimizing glucose control and medical nutrition therapy using a Step 2 American Heart Association diet to decrease the amount of saturated fat in the diet. B

No change

After the age of 10 years, addition of a statin is suggested in patients who, despite medical nutrition therapy and lifestyle changes, continue to have LDL cholesterol >160 mg/dL (4.1 mmol/L) or LDL cholesterol >130 mg/dL (3.4 mmol/L) and one or more cardiovascular disease risk factors, following

I suggest we elevate the level of evidence for this based on AdDIT to ‘A’. RCT of statin v placebo.

Reword in parallel with hypertension recommendation, possible B evidence level

Dunger NEJM ’17 in press. Presented at ADA

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reproductive counseling and implementation of effective birth control due to the potential teratogenic effects of statins. E The goal of therapy is an LDL cholesterol value <100 mg/dL (2.6 mmol/L). E

No change

New references not related to a particular recommendation

Smoking Elicit a smoking history at initial and follow-up diabetes visits.Discourage smoking in youth who do not smoke and encourage smoking cessation in those who do smoke. B

Elicit a smoking history at initial and follow-up diabetes visits and .Ddiscourage smoking in youth who do not smoke and encourage smoking cessation in those who do smoke. AB

Consistency with PS.

Level of evidence A

New references not related to a particular recommendation

Microvascular Complications Annual screening for albuminuria with a random spot urine sample for albumin–to–creatinine ratio should be considered once the child has had type 1 diabetes for 5 years. B

Annual screening for albuminuria with a random spot urine sample for albumin–to–creatinine ratio should be performed at puberty or at age >10 years, whichver is earlier,considered

Consistency with PS

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once the child has had type 1 diabetes for 5 years. B

Estimate glomerular filtration rate at initial evaluation and then based on age, diabetes duration, and treatment. E

Delete as recommendation but include sentence Discuss with Ian

An estimation of glomerular filtration rate (eGFR) (124) can be approximated based on some routine labs along with consideration of clinical status, age, diabetes duration, and therapies. Improved methods are needed to screen for early GFR loss since eGFR is inaccurate at GFR > 60 ml/min/1.73m2 (125).

124. Schwartz GJ, Work DF. Measurement and Estimation of GFR in Children and Adolescents. Clin J Am Soc Nephrol. 2009 Nov 1;4(11):1832–43. 125. Inker LA, Schmid CH, Tighiouart H, Eckfeldt JH, Feldman HI, Greene T, et al. Estimating glomerular filtration rate from serum creatinine and cystatin C. N Engl J Med. 2012 Jul 5;367(1):20–9.

When persistently elevated urinary albumin-to-creatinine ratio (>30 mg/g) is documented with at least two of three urine samples, treatment with an ACE inhibitor should be considered and the dose titrated to maintain blood pressure within the age-appropriate normal range. The urine samples should be obtained over a 6-month interval following efforts to improve glycemic control and normalize blood pressure. C

An ACE inhibitor or an angiotensin receptor blocker (ARB), titrated to normalization of albumin excretion, should be considered when elevated urinary albumin–to–creatinine ratio (>30 mg/g) is documented (two of three urine samples obtained over a 6-month interval following efforts to improve glycemic control and normalize blood pressure). B->A

Consistency with PS. Level of evidence A Doesn’t make sense, keep original 2017 text, reevaluate PS recommendation, B level evidence

Dunger, NEJM ’17 in press RCT of ACE/placebo for elevated ACR.

An initial dilated and comprehensive

No change

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eye examination is recommended at age ≥10 years or after puberty has started, whichever is earlier, once the youth has had type 1 diabetes for 3–5 years. B

Change to after 5 years

After the initial examination, annual routine follow-up is generally recommended. Less frequent examinations, every 2 years, may be acceptable on the advice of an eye care professional. E

After the initial examination, annual routine follow-up is generally recommended. Less frequent examinations, every 2 years, may be acceptable on the advice of an eye care professional and based on risk factor assessment. E

Consistency with PS.

Look for cohort studies? Raise to B?

Consider an annual comprehensive foot exam for the child at the start of puberty or at age ≥10 years, whichever is earlier, once the youth has had type 1 diabetes for 5 years. E

Consider an annual comprehensive foot exam for the child adolescent at the start of puberty or at age ≥10 years, whichever is earlier, once the youth has had type 1 diabetes for 5 years. BE

Change evidence grade to B based on references

119. American Diabetes Association. 10. Microvascular Complications and Foot Care. Diabetes Care. 2017 Jan;40(Suppl 1):S88–98

131. Jaiswal M, Divers J, Dabelea D, Isom S, Bell RA, Martin CL, et al. Prevalence of and Risk Factors for Diabetic Peripheral Neuropathy in Youth With Type 1 and Type 2 Diabetes: SEARCH for Diabetes in Youth Study. Diabetes Care. 2017 Jul 3;

132. Pop-Busui R,

122

Boulton AJM, Feldman EL, Bril V, Freeman R, Malik RA, et al. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136–54

Type 2 Diabetes Screening and Diagnosis Risk-based

screening for prediabetes and/or type 2 diabetes should be considered in children and adolescents after the onset of puberty or after 10 years of age, whichever occurs earlier, who are overweight (BMI >85th%) or obese (BMI >95th%) and who have additional risk factors for diabetes (See Table X for evidence grading of risk factors).

Evidence level?

If tests are normal, repeat testing at a minimum of 3-year intervals (E), or more frequently if BMI is increasing C.

Fasting plasma glucose, 2-h plasma glucose after 75-g oral glucose tolerance test and A1c can be

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used to test for prediabetes or diabetes. B

Management Initiate

pharmacologic therapy, in addition to lifestyle therapy, at diagnosis of type 2 diabetes. A

In incidentally diagnosed or metabolically stable patients (A1C < 8.5% and asymptomatic), metformin is the initial pharmacological treatment of choice if renal function is normal. A

We recommend that youth who present with marked hyperglycemia (BG >250 mg/dl, HbA1c > 8.5%) without acidosis, but who are symptomatic with polyuria, polydipsia, nocturia and/or weight loss should be treated initially with basal insulin as metformin is initiated and titrated. E

We suggest that when the target for

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glycemic control is no longer met with metformin monotherapy, or if contraindications or intolerable side effects of metformin develop, basal insulin therapy should be initiated. E

We suggest that if the combination of metformin plus basal insulin is ineffective at achieving or maintaining glycemic control, more aggressive approaches to insulin therapy be initiated. E

We recommend against the use of non-approved medications in youth with type 2 diabetes. B

All youth with type 2 diabetes and their families should receive comprehensive diabetes self-management education/support that is specific to youth with type 2 diabetes and is culturally competent. B

Lifestyle Management Overweight/obese Same as adults?

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youth with type 2 diabetes and their families should be provided with developmentally and culturally appropriate comprehensive lifestyle programs that are integrated with diabetes management to achieve 7-10% decrease in excess weight. C

Normalize for growth? 7-10% questoin

Given the necessity of long-term weight control and lifestyle management for children and adolescents with type 2 diabetes, lifestyle intervention should be based on a chronic care model and offered in the context of diabetes care. E

Youth with diabetes, like all children, should be encouraged to participate in at least 30-60 minutes of moderate to vigorous physical activity per day (and strength training on at least 3 days/week) B and decrease sedentary behavior. C

Nutrition for youth

126

with type 2 diabetes, like all children, should focus on healthy eating patterns that emphasize consumption of nutrient dense, high quality foods and decrease consumption of calorie dense, nutrient poor foods, particularly sugar-added beverages and fast foods. B

New references not related to a particular recommendation

Transition from Pediatric to Adult Care Health care providers and families should begin to prepare youth with diabetes in early to mid-adolescence and, at the latest, at least 1 year before the transition to adult health care. E

Health carePediatric diabetes providers and families should begin to prepare youth with diabetesfor transition in early to mid- adolescence and, at the latest, at least 1 year before the transition to adult health care. E

Consistency with PS. 180. Garvey KC, Foster NC, Agarwal S, DiMeglio LA, Anderson BJ, Corathers SD, et al. Health Care Transition Preparation and Experiences in a U.S. National Sample of Young Adults With Type 1 Diabetes. Diabetes Care. 2017 Mar;40(3):317–24. Consider adding from PS: 181. Transition Resources - Pediatric to Adult Health Care [Internet]. [cited 2017 Jun 22]. Available from: https://www.niddk.nih.gov/health-information/health-communication-programs/ndep/living-with-diabetes/youth-

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teens/transition-adult-health-care/resources/Pages/resourceslist.aspx 182. Managing the Transition of Care for Patients with Type 1 Diabetes | Endocrine Society [Internet]. [cited 2017 Jun 20]. Available from: https://www.endocrine.org/education-and-practice-management/quality-improvement-resources/clinical-practice-resources/transition-of-care

Both pediatricians and adult health care providers should assist in providing support and links to resources for the teen and emerging adult. B

Both pediatricians and adult diabetes health care providers should assist in provideing support and links to resources for the teen and emerging transitioning young adults. E

Consistency with PS.

NOTE: not sure why this is B in SOC 17 and E in PS?

New references not related to a particular recommendation

Mays et al. An Evaluation of Recurrent Diabetic Ketoacidosis, Fragmentation of Care, and Mortality Across Chicago. Diabetes Care. 2016 Oct;39(10):1671-6

Patients with recurrent DKA , which is associated with poorer clinical outcomes. "Fragmentation" in healthcare delivery means the systemic misalignment of incentives, or lack of coordination, that spawns inefficient allocation of resources or harm to patients. Fragmentation adversely impacts quality, cost, and outcomes.

Management of Diabetes in Pregnancy Starting at puberty, preconception counseling should

No change

128

be incorporated into routine diabetes care for all girls of childbearing potential. A Family planning should be discussed and effective contraception should be prescribed and used until a woman is prepared and ready to become pregnant. A

No change

Preconception counseling should address the importance of glycemic control as close to normal as is safely possible, ideally A1C < 6.5% (48 mmol/mol), to reduce the risk of congenital anomalies. B

No change

Women with preexisting type 1 or type 2 diabetes who are planning pregnancy or who have become pregnant should be counseled on the risk of development and/or progression of diabetic retinopathy. Dilated eye examinations should occur before pregnancy or in the first trimester, and then should be monitored every

No change

129

trimester and for 1 year postpartum as indicated by degree of retinopathy and as recommended by the eye care provider. B Lifestyle change is an essential component of management of gestational diabetes mellitus and may suffice for treatment for many women. Medications should be added if needed to achieve glycemic targets. A

No change

Insulin is the preferred medication for treating hyperglycemia in gestational diabetes mellitus, as it does not cross the placenta to a measurable extent. Metformin and glyburide may be used, but both cross the placenta to the fetus,with metformin likely crossing to a greater extent than glyburide. All oral agents lack long-term safety data. A

No change Cochrane Data Base evaluation of RCTs for both statements.

Metformin, when used to treat polycystic ovary syndrome and induce ovulation,

No change

130

need not be continued once pregnancy has been confirmed. A Potentially teratogenic medications (ACE inhibitors, statins, etc.) should be avoided in sexually active women of childbearing age who are not using reliable contraception. B

No change

Fasting and postprandial self-monitoring of blood glucose are recommended in both gestational diabetes mellitus and preexisting diabetes in pregnancy to achieve glycemic control. Some women with preexisting diabetes should also test blood glucose preprandially. B

No change

Due to increased red blood cell turnover, A1C is lower in normal pregnancy than in normal nonpregnant women. The A1C target in pregnancy is 6–6.5% (42–48 mmol/mol); <6% (42 mmol/mol) may be optimal if this can be

No change except clarification

131

achieved without significant hypoglycemia, but the target may be relaxed to <7% (53 mmol/mol) if necessary to prevent hypoglycemia. B In pregnant patients with diabetes and chronic hypertension, blood pressure targets of 120–160/80–105 mmHg are suggested in the interest of optimizing long-term maternal health and minimizing impaired fetal growth. E

No change

Women with preexisting type 1 or type 2 diabetes should be prescribed low dose aspirin 60-150 mg/day (usual dose 81 mg/day) from the end of the first trimester until the baby is born, in order to lower the risk of preeclampsia.A

Henderson JT, Whitlock EP, O'Conner E, et al. Low-Dose Aspirin for the Prevention of Morbidity and Mortality From Preeclampsia: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. (Evidence Syntheses, No. 112.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK196392/ Werner EF, Hauspurg AK, Rouse DJ. A cost–benefit analysis of low-dose aspirin prophylaxis for the prevention of

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preeclampsia in the United States Obstetrics & Gynecology 2015;126(6):1242-1250

Health care providers should provide information to mothers with preexisting diabetes or gestational diabetes describing the many benefits of breast feeding, including the likelihood that breast feeding lowers the risk of childhood obesity in the offspring and subsequent diabetes in mothers and offspring. B

Owen CG, Martin RM, Whincup PH, Smith GD, Cook DG. Effect of infant feeding on the risk of obesity across the life span: a quantitative review of published evidence. Pediatrics 2005; 115: 1367-1377 (B) Weng SF, Redsell SA, Swift JA, Yang M, Glazebrook CP. Systematic review and meta-analyses of risk factors for childhood overweight identifiable during infancy. Archives of Disease in Childhood 2012; 97: 1019-1026 (B)Gunderson EP, Hurston SR, Ning X, Loi JC et al for the Study of Women, Infants Feeding and Type 2 Diabetes after GDM pregnancy Investigators. Lactation and progression to type 2 diabetes mellitus after gestational diabetes mellitus: a prospective cohort study. Ann Internal Med 2015; 163(12): 889-898. (B) Crume TL, Ogden LG, Mayer-Davis EJ, Hamman RF et al. The impact of neonatal breast-feeding on growth trajectories of youth exposed and unexposed to diabetes in

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utero: the EPOCH Study. Int J Obes (Lond) 2012; 36(4): 529-534,. (B) Gunderson EP, Jacobs DR Jr., Chiang V et al. Duration of lactation and incidence of the metabolic syndrome in women of reproductive age according to gestational diabetes mellitus status: a 20-year prospective study in CARDIA (Coronary Artery Risk Development in Young Adults). Diabetes 2010; 59: 495-504. (B) Tanase-Nakao K, Arata N, Kawasaki M, Yasuhi I et al. Potential protective effect of lactation against incidence of type 2 diabetes mellitus in women with previous gestational diabetes mellitus: a systematic review and meta-analysis. Diabetes Metab Res Rev 2017; 33e2875. (B) Ziegler AG, Wallner M, Kaiser I, Rossbauer M et al. Long-term protective effect of lactation on the development of type 2 diabetes in women with recent gestational diabetes mellitus. Diabetes 2012; 61: 3167-3171. (B) Martens PJ, Shafer LA, Dean HJ, Sellers EAC et al. Breastfeeding initiation associated with reduced incidence of diabetes in mothers and offspring. Obstet Gynecol 2016;

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128(5): 1095-1104. (B) Lund-Blix NA, Stene LC, Rasmussen T et al. Infant feeding in relation to islet autoimmunity and type 1 diabetes in genetically susceptible children: the MIDIA Study. Diab Care 2015; 38: 257-263 (B)

New references not related to a particular recommendation

Diabetes Care in the Hospital Peform an A1C on all patients with diabetes or hyperglycemia admitted to the hospital if not performed in the prior 3 months. B

All patients independent of a prior diagnsosis of diabetes should have laboratory blood glucose (BG) testing on admission. Perform an A1C on all patients with diabetes or hyperglycemia (>140 mg/dl / 7.8 mmol/L) and history of diabetes admitted to the hospital if not performed in the prior 3 months. B

Rational? Reference?

Insulin therapy should be initiated for treatment of persistent hyperglycemia starting at a threshold ≥180 mg/dL (10.0 mmol/L). Once insulin therapy is started, a target

Insulin therapy should be initiated for treatment of persistent hyperglycemia starting at a threshold ≥180 mg/dL (10.0 mmol/L). Once insulin therapy is started, a target

Should change level of evidence for noncritically ill patients. A

GE Umpierrez (RABBIT 2 Surgery), Diabetes Care 34(2):256-61, 2011. Phillips VL. A Comparison of Inpatient Cost Per Day in General Surgery Patients with T2DTreated with Basal-Bolus versus Sliding Scale Insulin Regimens. Pharmacoeconom Open.

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glucose range of 140–180 mg/dL (7.8–10.0 mmol/L) is recommended for the majority of critically ill patients A and noncritically ill patients. C

glucose range of 140–180 mg/dL (7.8–10.0 mmol/L) is recommended for the majority of critically ill patients A and noncritically ill patients. CA

2017;1(2):109-115. Perioperative Glycemic Control and the Effect on Surgical Site Infections in Diabetic Patients Undergoing Foot and Ankle Surgery. Sadoskas D, Suder NC, Wukich DK. Foot Ankle Spec. 2016 Feb;9(1):24-30.

More stringent goals, such as <140 mg/dL (7.8 mmol/L), may be appropriate for selected patients, as long as this can be achieved without significant hypoglycemia. C

More stringent goals, such as <140 mg/dL (7.8 mmol/L), may be appropriate for selected patients,if as long as this can be achieved without significant hypoglycemia. CB Or No change?

Rationale? Reference?

Intravenous insulin infusions should be administered using validated written or computerized protocols that allow for predefined adjustments in the insulin infusion rate based on glycemic fluctuations and insulin dose. E

No change Heart Lung. 2015 Sep-Oct;44(5):430-40. doi: 10.1016/j.hrtlng.2015.06.004. Epub 2015 Jun 29. The effectiveness of tight glycemic control on decreasing surgical site infections and readmission rates in adult patients with diabetes undergoing cardiac surgery: A systematic review.

Basal insulin or a basal plus bolus correction insulin regimen is the preferred treatment for noncritically ill patients with poor oral intake or those

Basal insulin or a bBasal plus bolus correction, or a basal bolus insulin regimen is the preferred treatment for noncritically ill patients. with poor

Heart failure? Continue debate. Include discussion in text: The use of DPP4 i (B) alone or in combination with

1, Sita Hospital_Pilot_ Umpierrez et al. D Care 2013 2. Sita-Hospital Trial- Pasquel et al. Lancet Diabetes & Endocrinology 2017 3. Sita Plus Basal_ Nauck

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who are taking nothing by mouth. An insulin regimen with basal, nutritional, and correction components is the preferred treatment for noncritically ill hospitalized patients with good nutritional intake. A

oral intake or those who are taking nothing by mouth. An insulin regimen with basal, nutritional, and correction components is the preferred treatment for noncritically ill hospitalized patients with good nutritional intake. A The use of DPP4 i alone or in combination with basal insulin may be appropriate in non-ICU patients with mild-moderate hyperglycemia. B (A?)

basal insulin may be appropriate for blood glucose control in non-ICU patients with mild-moderate hyperglycemia. B

et al. Lancet Diabetes & Endocrinology 2017 4. Saxa-Hospital Trial_ Garg et al. BMJ Diabetes Res & Care 2017

Sole use of sliding scale insulin in the inpatient hospital setting is strongly discouraged. A

No change

A hypoglycemia management protocol should be adopted and implemented by each hospital or hospital system. A plan for preventing and treating hypoglycemia should be established for each patient. Episodes of hypoglycemia in the hospital should be documented in the medical record

No change A hypoglycemia management protocol should be adopted and implemented by each hospital or hospital system. A plan for preventing and treating hypoglycemia should be established for each patient. Episodes of

Rationale

137

and tracked. E hypoglycemia in the hospital should be documented in the medical record and tracked. E

The treatment regimen should be reviewed and changed if necessary to prevent further hypoglycemia when a blood glucose value is <70 mg/dL (3.9 mmol/L). C

No change

There should be a structured discharge plan tailored to the individual patient with diabetes. B

No change

New references not related to a particular recommendation

Effect of Preoperative Diabetes Management on Glycemic Control and Clinical Outcomes after Elective Surgery. Garg R, et al. Ann Surg. 2017 May 25 Preoperative and inpatient diabetes management improves glycemic control on the day of surgery and postoperatively and decreases the incidence of hypoglycemia. These changes may eventually improve clinical outcomes. Although statistically significant, the decrease in LOS was of equivocal clinical significance in this study. Effect of basal insulin dosage on blood glucose concentration in ambulatory surgery patients with type 2 diabetes. Demma LJ, Carlson KT, Duggan EW, Morrow JG 3rd, Umpierrez G. J Clin Anesth. 2017 Feb;36:184-188. The effectiveness of tight glycemic control on decreasing surgical site infections and readmission rates in adult patients with diabetes undergoing cardiac surgery: A systematic review. Boreland L, Scott-Hudson M, Hetherington K, Frussinetty A, Slyer JT. Heart Lung. 2015 Sep-Oct;44(5):430-40. Aloi et al. Comparison of an Electronic Glycemic Management System Versus Provider-Managed Subcutaneous Basal Bolus Insulin Therapy in the Hospital Setting. Journal of Diabetes Science and Technology 2017,

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Vol. 11(1) 12–16 Mays et al. An Evaluation of Recurrent Diabetic Ketoacidosis, Fragmentation of Care, and Mortality Across Chicago. Diabetes Care. 2016 Oct;39(10):1671-6. Welsh et al. INPATIENT HYPOGLYCEMIC EVENTS IN A COMPARATIVE EFFECTIVENESS TRIAL FOR GLYCEMIC CONTROL IN A HIGH-RISK POPULATION. Endocr Pract. 2016;22:1040-1047

Khan et al. Associations between home insulin dose adjustments and glycemic outcomes at hospital admission. Diabetes Research Clinical Practice 2017 127:51-58