Internet delivered diabetes self-management education: a ... Web viewThe recommendation for doing...

Standards of Medical Care in Diabetes—2017Evidence Table

Recommendation Reason for Change 2016 references that support recommendation (list citation #)

New Evidence for 2017 (hyperlinked reference title/s)

Strategies for improving CareA patient-centered communication style usingthat active listening to elicit incorporates patient preferences and, assesses literacy, and numeracy, and addresses cultural barriers to care should be usedshould be incorporated into treatment strategies to optimize health outcomes and health-related quality of life. B

Now provides recommendation on a skill that can help providers get the information from patients that they need to inform treatment.

Do we want to say anything about goal setting here? (reference 10) and also could just say overcoming barriers (since literacy/numeracy covered later)

13, 14-17, 55 http://www.ncbi.nlm.nih.gov/pubmed/26699083

Treatment decisions should be timely, and based on evidence-based guidelines, and made in collaboration with patients based on that are tailored to individual patient preferences, prognoses, and comorbidities. B

Should include mention of collaboration/shared decision making

6, 10, 12 (timely),18-20, 34

http://www.ncbi.nlm.nih.gov/pubmed/26458383

Care should be aligned with components of the Chronic Care Model to ensure productive interactions between a prepared proactive practice team and an informed activated patient. A

7,8 (CCM)29, 30 (activated patients)

New review article (2015) in Journal of Evaluation in Clinical Practice (IF 1.05), but current references are in higher tier journal and conclusions are similar

7- Preventing Chronic

1




Disease (IF 2.17)8- Health Affairs (IF 5.23)

Providers should consider the burden of treatment and patient levels of confidence/self-efficacy for management behaviors as treatment recommendations are made. EWhen feasible, care systems should support team-based care, community involvement, patient registries, and decision support tools to meet patient needs. B

Community involvement language could stay here or move to new section

6,7, 9-11, 21, 22

Providers should assess social context, including potential food insecurity, housing stability, and financial barriers (to treatment adherence?) and apply to treatment decisions.A

Proposed heading: Social Determinants of Health

This broadens the recommendation to incorporate other important aspects of SDH but still names food insecurity/homelessness

Add information to text about what “appropriate resources” means

6, 14-17, 59 http://content.healthaffairs.org/content/34/11/1956

Providers should evaluate hyperglycemia and hypoglycemia in the context of food insecurity and propose solutions accordingly. A

59

Providers should recognize that homelessness, poor

2

literacy, and poor numeracy often occur with food insecurity, and appropriate resources should be made available for patients with diabetes. AReferral to existing local community resources should be made when available B

Proposed heading: Community support

Increasing evidence that integration of care management efforts that extend to the community warrants inclusion of support and community as a distinct bullet

6, 7, 31 Have ordered an article- need to review in its entirety

Provision of support for self-management from lay health coaches, navigators, or community health workers should be made available when feasible A

See above 49, 50, 51, 52, 54

Intensive glucose control is not advised for the improvement of poor cognitive function in hyperglycemic individuals with type 2 diabetes. Treatment should be tailored to avoid significant hypoglycemia B

63

In individuals with poor cognitive function or severe hypoglycemia, glycemic therapy should be tailored to avoid significant hypoglycemia. C

This bullet seems a bit redundanthypoglycemia language

63

In individuals with diabetes at high cardiovascular risk, the

Discuss how statins don’t affect cognitive function negatively in

68

3

cardiovascular benefits of statin therapy outweigh the risk of cognitive dysfunction. A

text

If a second-generation antipsychotic medication is prescribed for adolescents or adults, with or without diabetes, changes in weight, blood glucose levelsglycemic control, and cholesterol levels should be carefully monitored and the treatment regimen should be reassessed. C

New data regarding elevated risk for adolescents

73 http://www.ncbi.nlm.nih.gov/pubmed/26792761

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

Changed to be more consistent with stated guidelines

Is this supposed to be a fasting glucose level specifically, and not any other glucose measure?

Screening versus testing

75 (2002)76 (2006

Clinical Infectious Disease (2015)


Classification and Diagnosis of DiabetesTesting Screening to assess risk for future diabetes in asymptomatic people should be considered in adults of any age who are overweight or

Dr. Herman would like to lead a discussion among the PPC about possible revision.

Table 2.2 edit

10,11 For Discussion:

Wang B, Zhuang R, Luo X, et al. Prevalence of metabolically healthy obese and metabolically obese but normal weight in adults

4



obese (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans) and in all adults. Testing is suggested in those who have one one or more additional risk factors for diabetes. B

Describe process in text, differentiation between screening for risk factors and testing for diabetes

Except for GDM—create separate bullet point for follow-up with GDM

Refer to ADA risk text?

Add commentary in text regarding ethnicity—ie lean, * in table, African americans. Add data, reference about how it’s mostly family history.

worldwide: A meta-analysis. Horm Metab Res 2015;47:839-845

Lotta LA, Abbasi A, Sharp SJ, et al. Definitions of metabolic health and risk of future type 2 diabetes in body mass index categories: a systematic review and network meta-analysis. Diabetes Care 2015;38(11):2177-2187

Lee SH, Yang HK, Ha HS, et al. Changes in metabolic health status over time and risk of developing type 2 diabetes: A prospective cohort study. Medicine (Baltimore) 2015;94(40):e1705.

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

No Change Recommended

10,11,24

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


10,11,32

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


Make change to recommendation and narrative in response to recent FDA advisory panel meeting on POC A1C testing?

10-15 For Discussion (Dr. Ratner):

MedPage Today Story

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


10,11

Testing to detect No Change 16,33-36 Possible addition?

5

http://www.medpagetoday.com/endocrinology/diabetes/59281









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

RecommendedType 2 diabetes in children and adolescents. American Diabetes Association. Diabetes Care 2000;23(3):381-389

Blood glucose rather than A1C should be used to diagnose acute onset of type 1 diabetes in individuals with symptoms of hyperglycemia. E


2

Inform the relatives of patients with type 1 diabetes of the opportunity to be tested for type 1 diabetes risk, but only in the setting of a clinical research study. E


No references currently cited in 2016 standards (supported by narrative and reference to clinicaltrials.gov)

Add GAD or antibody panel recommendation to catch adult-onset type 1 diabetes

Add short paragraph in type 2 diabetes section, describing LADA without saying LADA

Testing to detect 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

Dr. Herman would like to lead a discussion among the PPC about possible revision.

Added a subsection on “Screening in Dental Clinics” for consideration

21,25-27 For Discussion:

Wang B, Zhuang R, Luo X, et al. Prevalence of metabolically healthy obese and metabolically obese but normal weight in adults worldwide: A meta-analysis. Horm Metab Res 2015;47:839-845

Lotta LA, Abbasi A, Sharp SJ, et al. Definitions of metabolic health and risk of future type 2 diabetes in body mass index categories: a systematic review and network meta-analysis.

6










Diabetes Care 2015;38(11):2177-2187

Lee SH, Yang HK, Ha HS, et al. Changes in metabolic health status over time and risk of developing type 2 diabetes: A prospective cohort study. Medicine (Baltimore) 2015;94(40):e1705.

Dental Clinic Screening References:

Lalla E, Kunzel C, Burkett S, et al. Identification of unrecognized diabetes and pre-diabetes in a dental setting. J Dent Res 2011;90(7):855-860

Lalla E, Cheng B, Kunzel C, et al. Dental findings and identification of undiagnosed hyperglycemia. J Dent Res 2013;92(10):888-892

Herman WH, Taylor GW, Jacobson JJ, et al. Screening for prediabetes and type 2 diabetes in dental offices. J Public Health Dent 2015;75(3):175-182

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


10,11,24

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


10,11,32

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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


10-15

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


22,23

Testing to detect type 2 diabetes should be considered in children and adolescents who are overweight or obese and who have two or more additional risk factors for diabetes. E


16,33-36 Possible addition?

Type 2 diabetes in children and adolescents. American Diabetes Association. Diabetes Care 2000;23(3):381-389

Test for undiagnosed type 2 diabetes at the first prenatal visit in those with risk factors, using standard diagnostic criteria. B


37,38,

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

Question for Discussion:

Maintain current recommendations per Table 2.5, or should this be changed to recommend one-step strategy only? If the two-step strategy stays in the table, should it be simplified to include either reference 55 or 56 only (for simplification)?

39,40-47 Donovan L, Hartling L, Muise M, Guthrie A, Vandermeer B, Dryden DM. Screening tests for gestational diabetes: a systematic review for the U.S. Preventive Services Task Force. Annals of Internal medicine 2013: 159: 1-8.

Khalafallah A, Phuah E, Al-Barazan AM, Nikakis I, Radford A, Clarkson W, Trevett C, Brain T, Gebski V, Corbould A. Glycosylated haemoglobin for screening and diagnosis

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of gestational diabetes mellitus. BMJ Open 2016 Apr 4; 6(4): e011059

Harper LM, Mele L, Landon MB, et al. Carpenter-Coustan Compared With National Diabetes Data Group Criteria for Diagnosing Gestational Diabetes. Obstet Gynecol 2016; 127:893.

Werner EF, Pettker CM, Zuckerwise L et al. Screening for gestational diabetes mellitus: are the criteria proposed by the International Association of the Diabetes in Pregnancy Study Groups cost-effective? Diabetes Care 2012; 35: 529-535.

Yjmei W, Huixia Y, Weiwei Z, Hongyun Y, Haixia L, Jie Y, Cuiklin Z. International Association of Diabetes and pregnancy Study Group criteria is suitable for gestational diabetes mellitus diagnosis: further evidence from China. Chinese medical Journal 2014; 127: 3553-3556.

Feldman RK, Tieu RS, Yasumara L. Gestational diabetes screening: the IADPSG compared with the Carpentar-Coustan screening. Obstet

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Gynecol 2016; 127: 10-17.

Mayo K, Melamed N, Vandenberghe H, Berger H. The impact of adoption of the International Association of Diabetes in Pregnancy Study Group criteria for the screening and diagnosis of gestational diabetes. Am J Obstet Gynecol 2015: 212: 224e1-9.

McIntyre HD, Sacks DA, Barbour LA, Feig D, Catalano PM, Damm P, McElduff A. Issues with the diagnosis and classification of hyperglycemia in early pregnancy. Diabetes Care 2016;39: 53-54

Screen Test women with gestational diabetes mellitus for persistent diabetes at 64–12 weeks postpartum, using the oral glucose tolerance test and clinically appropriate non-pregnancy diagnostic criteria. E

Per Dr. Coustan: “This comes from the chapter on management in pregnancy. The recommendation for doing the post partum OGTT at 6-12 weeks post partum is, to my knowledge, unencumbered by data. Rather it is informed by custom. In fact, most obstetricians see their patients at 6 weeks post partum. We recommend scheduling the test just before the post partum checkup so that the results can be discussed with the patient, and if the patient did not attend the test it can be

Reference added to narrative:

McIntyre HD, Sacks DA, Barbour LA, Feig D, Catalano PM, Damm P, McElduff A. Issues with the diagnosis and classification of hyperglycemia in early pregnancy. Diabetes Care 1026;39: 53-54

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rescheduled. I’ll try to craft some verbiage into the narrative in the treatment chapter about this.”

Women with a history of gestational diabetes mellitus should have lifelong screening for the development of diabetes or prediabetes at least every 3 years. B


Not specifically discussed in this section – Readers referred to “Management of Diabetes in Pregnancy” section

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

Minor wording change. Not specifically discussed in this section – Readers referred to “Management of Diabetes in Pregnancy” section

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

Minor wording change and evidence level changed to “A.”

48,49

Maturity-onset diabetes of the young should be considered in individuals who have mild stable fasting hyperglycemia and multiple family members with diabetes not characteristic of type 1 or type 2 diabetes. E

Delete per edits to following recommendations.

Because a diagnosis of maturity-onset diabetes of the young may impact therapy and lead to identification of other affected family members, consider referring individuals with diabetes not typicalChildren and

Revised and evidence level changed to “A.”

48,49

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adults who have diabetes not characteristic of type 1 or type 2 diabetes and that occursring in successive generations (suggestive of an autosomal dominant pattern of inheritance) to a specialist for further evaluationshould have genetic testing for maturity-onset diabetes of the young (MODY). AEIn both instances, consultation with a center specializing in diabetes genetics is recommended to understand the significance of these mutations and how best to approach further evaluation, treatment and genetic counseling. E

New suggested Recommendation.

N/A – New Recommendation

Annual screening for cystic fibrosis–related diabetes with oral glucose tolerance test should begin by age 10 years in all patients with cystic fibrosis who do not have cystic fibrosis–related diabetes. B

No Change Recommended.

54

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


54

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


53, 54

12

In patients with cystic fibrosis and impaired glucose tolerance without confirmed diabetes, prandial insulin therapy should be considered to maintain weight. B

Recommendation recommended to be removed by outside expert reviewer (Dr. Toni Moran). Per Dr. Moran: “I wasn't involved in that recommendation and don't agree with it, there are no good studies, just some small uncontrolled case series and an Australian paper with problematic baseline data. So no new studies, and if you prefer to keep it in that is fine but it is not B level evidence.”

54

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


54

Patients should be screened post-transplantation for hyperglycemia, with a formal diagnosis of PTDM being best made once a patient is stable on an immunosuppressive regimen and in the absence of an acute infection. E

New recommendation with addition of PTDM subsection. Recommendations and narrative reviewed by invited outside expert (Dr. Mark Molitch)

No evidence to preferred treatment.

NODAT versus PTDM—mean the same thing. Changed nomenclature to capture undiagnosed diabetes that was caught after transplant.

Immunosuppressive regimen trumps everything

N/A – New Subsection Sharif A, Hecking M, de Vries AP, et al. Proceedings from an international consensus meeting on posttransplantation diabetes mellitus: recommendations and future directions. Am J Transplant 2014;14(9):1992-2000

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The OGTT is the preferred test to make a diagnosis of PTDM. B



Hecking M, Werzowa J, Haidinger M, et al. New-onset diabetes after transplantation: Development, prevention, and treatment. Nephrol Dial Transplant 2013;28:550-566

Hecking M, Kainz A, Werzowa J, et al. Glucose metabolism after renal transplantation. Diabetes Care 2013;36:2763-2771

Sharif A, Moore RH, Baboolal K. The use of oral glucose tolerance tests to risk stratify for new-onset diabetes after transplantation: An underdiagnosed phenomenon. Transplantation 2006;82:1667-1672

Valderhaug TG, Jenssen T, Hartmann A, et al. Fasting plasma glucose and glycosylated hemoglobin in the screening for diabetes mellitus after renal

14















transplantation. Transplantation 2009;88:429-434

Immunosuppressive regimens shown to provide the best outcomes for patient and graft survival should be used, irrespective of PTDM risk. E



Comprehensive Medical Evaluation and Comorbidities AssessmentProvide routine vaccinations for patients with diabetes as for the general population according to age-related recommendations. C

No change

Administer hepatitis B vaccine to unvaccinated adults with diabetes who are aged 19–59 years. C

No change

Consider administering hepatitis B vaccine to unvaccinated adults with diabetes who are aged 60 years. C

No change

The following psychosocial factors should be assessed at the initial visit, monitored at periodic intervals, and when there is a patient specific indication for need of behavioral services such as a change in disease, treatment or life circumstances: symptoms of diabetes distress, depression,

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anxiety and disordered eating; and cognitive capacities. BPerformance of self-management behaviors as well as psychosocial factors impacting the person’s self-management should be monitored at every visit, including but not limited to diabetes distress/burdens and the impact of diabetes on health related quality of life. EScreen all patients with pre-diabetes, diabetes and/or a self-reported history of depression for depressive symptoms annually as well as when patients are experiencing a worsening of disease status or intensification of treatment with age-appropriate depression screening measures, recognizing that further evaluation will be necessary for positive screens B. (B, E)Positive screens for depressive symptoms should be followed by formal clinical diagnostic assessment. .BPatients who meet clinical diagnostic criteria for depression should be evaluated for antidepressant medications and/or psychotherapy.A

Maybe removed

Persons with diabetes

16

who clinically present with symptoms of disordered eating behavior, an eating disorder, or disrupted patterns of eating should be referred for re-evaluation of their treatment regimen and if symptoms indicate, to a behavioral health provider for assessment of eating and weight-related cognitions.BIf disordered eating behavior is suspected, assess for intentional omission of insulin or oral medication to intentionally cause weight loss. If identified, refer to a behavioral health provider for evaluation and intervention.B

Persons with diabetes who express fear, dread or irrational thoughts and/or show anxiety symptoms, as well as those exhibiting anxiety or excessive worries regarding diabetes complications, insulin injections or infusion, taking medications and/or hypoglycemia that interfere with adherence to medical treatment should be screened for anxiety B (B, D, E)

Alicia: Combine with below

Positive screens for anxiety or fear of hypoglycemia should be referred to a behavioral

17

health provider formal clinical diagnostic assessment.EPatients who meet clinical diagnostic criteria for anxiety disorders or fear of hypoglycemia should be referred for further evaluation for treatment with an anxiolytic medication and/or to a behavioral health provider. AIf a serious mental illness is suspected in a person with diabetes, immediate referral for diagnosis and treatment should be implemented to support diabetes self-care behaviors. BCoordinated management of diabetes, pre-diabetes and SMI is recommended to achieve diabetes treatment targets. EA complete medical evaluation should be performed at the initial visit to:Confirm the diagnosis and classify the type of diabetes. BDetect diabetes complications and potential comorbid conditions. E

No change

Assess for the presence of additional autoimmune conditions soon after the diagnosis and if symptoms or signs develop in patients with type 1 diabetes. E

Copied from children and adolescents

Review previous No change

18

treatment and risk factor control in patients with established diabetes. EBegin patient engagement in the formulation of a care management plan. B

No change

Develop a plan for continuing care. B

No change

Lifestyle ManagementIn accordance with the national standards for diabetes self-management education (DSME) and support (DSMS), all people with diabetes should participate in DSME to facilitate the knowledge, skills, and ability necessary for diabetes self-care and in DSMS to assist with implementing and sustaining skills and behaviors needed for ongoing self-management, both at diagnosis and as needed thereafter. B

OK(note – undergoing revision starting in Sept; for publication next year.

4, 5, 6, 7 Somewhere in the text we should acknowledge the emerging evidence that internet based diabetes education may be helpful:Diabetes Technol Ther. 2015 Jan;17(1):55-63. doi: 10.1089/dia.2014.0155.

Internet delivered diabetes self-management education: a review.

Pereira K1, Phillips B, Johnson C, Vorderstrasse A.

Andhttp://www.jmir.org/2015/4/e92/article by Sepah et al (including Anne Peters) on 2 yr online DM prevention program.

Effective self-management, improved clinical outcomes, health status, and quality of life are key outcomes of DSME and DSMS and should be measured and monitored as part of care. C

4, 6, 9, 10, 11, 12, 10, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23

DSME and DSMS should be patient centered, respectful, and

20, 21, 22, 23, 12, 26, Diabet Med. 2016 Mar 21. doi: 10.1111/dme.13120. [Epub ahead of print]

19

http://www.jmir.org/2015/4/e92/


http://www.ncbi.nlm.nih.gov/pubmed/?term=Vorderstrasse%20A%5BAuthor%5D&cauthor=true&cauthor_uid=25238257

http://www.ncbi.nlm.nih.gov/pubmed/?term=Vorderstrasse%20A%5BAuthor%5D&cauthor=true&cauthor_uid=25238257

http://www.ncbi.nlm.nih.gov/pubmed/?term=Johnson%20C%5BAuthor%5D&cauthor=true&cauthor_uid=25238257

http://www.ncbi.nlm.nih.gov/pubmed/?term=Phillips%20B%5BAuthor%5D&cauthor=true&cauthor_uid=25238257

http://www.ncbi.nlm.nih.gov/pubmed/?term=Pereira%20K%5BAuthor%5D&cauthor=true&cauthor_uid=25238257


responsive to individual patient preferences, needs, and values, which should guide clinical decisions. A

Reasons why patients referred to diabetes education programmes choose not to attend: a systematic review.

Horigan G1, Davies M2, Findlay-White F3, Chaney D3, Coates V1.


DSME and DSMS programs should have the necessary elements in their curricula that are needed to prevent the onset of diabetes. DSME and DSMS programs should therefore tailor their content specifically when prevention of diabetes is the desired goal. B

Ok – or this could be part of the “prevention” section. It may be misplaced here.

Because DSME and DSMS can result in cost savings and improved outcomes B, DSME and DSMS should be adequately reimbursed by third-party payers. E

The section on reimbursement only references #4 – but I think should include 16, 17.

Self-management behaviors including medication adherence should be assessed directly and regularly. A1c is not a reliable indicator of difficulties with diabetes self-management. B

Psychosocial positon statement

Providers should be aware that diabetes self-management behaviors require a foundation of diabetes

Consider deleting?

20




education, skill building, emotional support and access to care resources.BPeople with diabetes who are demonstrating difficulty with self-management behaviors should be referred for assessment of health literacy and numeracy. B

Delete, redundant with above

Persons of all ages who demonstrate difficulty performing routine self-management tasks should be treated using targeted behavioral interventions to support diabetes self-care.EPeople with diabetes should be monitored for diabetes distress routinely and especially when treatment targets are not met for: regiment adherence or glycemic control; and/or the onset of diabetes complication BPeople with diabetes distress should be referred for diabetes education to identify and address areas of diabetes self-care that are most relevant to the patient and most problematic for diabetes outcomes. Those whose self-care remains impaired after tailored diabetes education should be referred to a behavioral health provider for

21

evaluation and treatment. EInvolvement of caregivers and family members in identifying, preventing and/or resolving psychosocial problems should be assessed, solicited and supported. EStandardized/validated tools and methods should be used for psychosocial monitoring, assessment and intervention whenever possible. Psychosocial assessment and intervention materials should be appropriate for the age and cognitive capacity of the person with diabetes.EPsychosocial problems should be addressed upon identification. If an intervention cannot be initiated during the visit when the problem is identified, a follow-up visit or referral to a qualified behavioral health care provider should be scheduled during that visit. EAn individualized MNT program, preferably provided by a registered dietitian, is recommended for all people with type 1 or type 2 diabetes. A

ok 34, 35 Add 2015 EAL citations for T1 and T2https://www.andeal.org/topic.cfm?menu=5305&cat=5595

For people with type 1 diabetes or those with type 2 diabetes who are prescribed a flexible

For type 1, insulin dosing should also take into account fat content of the meal. (especially

37 Diabetes Care. 2016 Jul 7. pii: dc152855. [Epub ahead of print]Optimized Mealtime

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insulin therapy program, education on how to use carbohydrate and in some cases fat and protein counting or estimation to determine mealtime insulin dosing can improve glycemic control. A

larger quantiries – over 40 gm)

Reexamine to determine if fat/protein should be included in recommendation or in the text

Insulin Dosing for Fat and Protein in Type 1 Diabetes: Application of a Model-Based Approach to Derive Insulin Doses for Open-Loop Diabetes Management.Bell KJ1, Toschi E2, Steil GM3, Wolpert HA4.http://www.ncbi.nlm.nih.gov/pubmed/27388474

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. BA simple and effective approach to glycemia and weight management emphasizing healthy food choices and portion control 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

39 Add reference on effectiveness of plate method: Bowen et al. Pt Educ and Counseling - 2016http://www.ncbi.nlm.nih.gov/pubmed/27026388

• 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

23







payers. EModest weight loss achievable by the combination of lifestyle modification and the reduction of energy calorie intake benefits overweight or obese adults with type 2 diabetes and also those at risk for diabetes. Interventional programs to facilitate this process are recommended. A

Update ref #50 to be

2015 Circulation reference


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

47,48,49,50Add – Ajala - 2013http://www.ncbi.nlm.nih.gov/pubmed/23364002

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

Not “pattern” --meal composition instead

Incorporate into text and/or recommendation above

Should say something more about “patterns”such as plant based; Mediterranean….http://www.ncbi.nlm.nih.gov/pubmed/27476051

USDA Dietary Guidelines

Diet quality index paper:http://www.ncbi.nlm.nih.gov/pubmed/25319012

Recent paper from Canada on plant based diets:http://www.ncbi.nlm.nih.gov/pubmed/27476051

http://www.thelancet.com/journals/lancet/article/

24













PIIS0140-6736(14)60613-9/abstract

Carbohydrate intake from whole grains, vegetables, fruits, legumes, and 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

53-56

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

56 Newer rferences to support”http://www.ncbi.nlm.nih.gov/pubmed/26199070

and from Frank Hu:http://www.ncbi.nlm.nih.gov/pubmed/23763695

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

53 ? - 61

Whereas data on the ideal total dietary fat content for people with diabetes are inconclusive, an eating

65-73

Omit word “mono”http://www.ncbi.nlm.nih.gov/pubmed/27428849Ann Intern Med. 2016 Jul

25







plan emphasizing elements of a Mediterranean-style diet rich in monounsaturated 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

19. doi: 10.7326/M16-0361. [Epub ahead of print]Effects on Health Outcomes of a Mediterranean Diet With No Restriction on Fat Intake: A Systematic Review and Meta-analysis.Bloomfield HE, Koeller E, Greer N, MacDonald R, Kane R, Wilt TJ.

Eating foods rich in long-chain omega-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 omega-3 dietary supplements. A

Importance of replacing sat fat and trans fats with unsaturated fats

Wang D et al. JAMA Internal Medicine July 5 2016Association of Specific Dietary Fats With Total and Cause-Specific Mortalityhttp://archinte.jamanetwork.com/article.aspx?articleid=2530902

new article from Erika:http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002094

There is no clear evidence that dietary supplementation in people with diabetes who don’t have underlying deficiences with vitamins, minerals, herbs, or spices can improve diabetes, and there may be safety concerns regarding the long-term use of antioxidant supplements such as

Acknowledge vitamin D in text

Note: While low Mg intake is linked with increased risk of T2DM, if the indivual consumes a varied diet rich in plant based Mg sources (whole grains, nuts, leafy greens)- this risk is reduced.

I find nothing compelling for T1DM re: Mg supplementationThis study concluded:

Comments fromMozaffarian D (Circulation Jan 12, 2016):“Ca and Mg supplements cannot yet be recommended for general CVD prevention”“VitD supplementation – not warrented as means to improve cardiometabolic heatlh”

J Clin Endocrinol Metab. 2014 Oct;99(10):3551-60. doi: 10.1210/jc.2014-

26

http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002094



http://archinte.jamanetwork.com/article.aspx?articleid=2530902



vitamins E and C and carotene. C

further study is needed to determine if supplementation is warranted.” Lin CC et al. Clin Nutr 2016 Aug:35(4):880-4 doi: 10.1016/j.clnu.2015.05.022. Epub 2015 Jun 9 Magnesium, Zinc and chromium levels in children, adol and young adults with T1DM

Possible addition of B12 /metformin?"Long-term use of metformin may be associated with biochemical B12 deficiency, and routine measurement of vitamin B12 levels in metformin-treated patients should be considered.”

2136. Epub 2014 Jul 25.Clinical review: Effect of vitamin D3 supplementation on improving glucose homeostasis and preventing diabetes: a systematic review and meta-analysis.Seida JC1, Mitri J, Colmers IN, Majumdar SR, Davidson MB, Edwards AL, Hanley DA, Pittas AG, Tjosvold L, Johnson JA.“No effect of D3 supplementation on glucose homeostasis or diabetes prevention”

Risk of Type 2 DM is lower in US Adults taking Chromium containing supplements. McIver DJ et al. Am Society for Nutrition. Oct 7 2015.

Magnesium – reducing risk for T2DM:http://www.ncbi.nlm.nih.gov/pubmed/24089547

Also 2011 article in D.Care -http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3161260/

B12http://www.ncbi.nlm.nih.gov/pubmed/26900641

Use of NNSs has the potential to reduce overall calorie and carbohydrate intake if substituted for caloric sweeteners without compensation by intake of additional calories

From 2013 paper. Added section in yellow.

Check nutrition recommendation for evidence level

BUse 2012 paper published in DCarehttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3402256/

27

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3402256/









from other food sources and are safe to use in moderation.

Table to be used:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3402256/table/T1/

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). CAlcohol 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. BAs 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. BChildren with diabetes or prediabetes should be encouraged to engage in at least 60 min of physical activity each day. BAdults with diabetes should be advised to perform at least 150

28

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3402256/table/T1/



min/week of moderate-intensity aerobic physical activity (50–70% of maximum heart rate), spread over at least 3 days/week with no more than 2 consecutive days without exercise. AAll individuals, including those with diabetes, should be encouraged to reduce sedentary time, particularly by breaking up extended amounts of time (>90 min) spent sitting. BIn the absence of contraindications, adults with type 2 diabetes should be encouraged to perform resistance training at least twice per week. AAll adults, and particularly those with type 2 diabetes, should decrease the amount of time spent in daily sedentary behavior.B

This implies that everyone spends too much time sedentary

Dempsey PC, Owen N, Biddle SJ, Dunstan DW: Managing sedentary behavior to reduce the risk of diabetes and cardiovascular disease. Curr Diab Rep 2014;14:522 http://www.ncbi.nlm.nih.gov/pubmed/25052856

Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA: Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: A systematic review and

29

meta-analysis. Ann Intern Med 2015;162:123-132 http://www.ncbi.nlm.nih.gov/pubmed/25599350

Chau JY, Grunseit AC, Chey T, Stamatakis E, Brown WJ, Matthews CE, Bauman AE, van der Ploeg HP: Daily sitting time and all-cause mortality: A meta-analysis. PLoS One 2013;8:e80000 http://www.ncbi.nlm.nih.gov/pubmed/24236168

Wilmot EG, Edwardson CL, Achana FA, Davies MJ, Gorely T, Gray LJ, Khunti K, Yates T, Biddle SJ: Sedentary time in adults and the association with diabetes, cardiovascular disease and death: Systematic review and meta-analysis. Diabetologia 2012;55:2895-2905 http://www.ncbi.nlm.nih.gov/pubmed/22890825

Fritschi C, Park H, Richardson A, Park C, Collins EG, Mermelstein R, Riesche L, Quinn L: Association between daily time

30

spent in sedentary behavior and duration of hyperglycemia in type 2 diabetes. Biol Res Nurs 2016; 18(2):160-6 http://www.ncbi.nlm.nih.gov/pubmed/26282912

Prolonged sitting should be interrupted with bouts of light activity every 30 min for blood glucose benefits, at least in adults with type 2 diabetes. C

Dempsey PC, Owen N, Biddle SJ, Dunstan DW: Managing sedentary behavior to reduce the risk of diabetes and cardiovascular disease. Curr Diab Rep 2014;14:522 http://www.ncbi.nlm.nih.gov/pubmed/25052856

Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA: Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: A systematic review and meta-analysis. Ann Intern Med 2015;162:123-132 http://www.ncbi.nlm.nih.gov/pubmed/25599350

Chau JY, Grunseit AC, Chey T, Stamatakis E, Brown WJ, Matthews CE, Bauman AE, van der Ploeg HP: Daily sitting time and all-cause mortality: A meta-analysis. PLoS One 2013;8:e80000 http://www.ncbi.nlm.nih.gov/pubmed/24236168

Wilmot EG, Edwardson CL, Achana FA, Davies

31







MJ, Gorely T, Gray LJ, Khunti K, Yates T, Biddle SJ: Sedentary time in adults and the association with diabetes, cardiovascular disease and death: Systematic review and meta-analysis. Diabetologia 2012;55:2895-2905 http://www.ncbi.nlm.nih.gov/pubmed/22890825

Fritschi C, Park H, Richardson A, Park C, Collins EG, Mermelstein R, Riesche L, Quinn L: Association between daily time spent in sedentary behavior and duration of hyperglycemia in type 2 diabetes. Biol Res Nurs 2016; 18(2):160-6 http://www.ncbi.nlm.nih.gov/pubmed/26282912

Buckley JP, Mellor DD, Morris M, Joseph F: Standing-based office work shows encouraging signs of attenuating post-prandial glycaemic excursion. Occup Environ Med 2014;71:109-111 http://www.ncbi.nlm.nih.gov/pubmed/24297826

Henson J, Davies MJ, Bodicoat DH, Edwardson CL, Gill JM, Stensel DJ, Tolfrey K, Dunstan DW, Khunti K, Yates T: Breaking up prolonged sitting with standing or walking

32







attenuates the postprandial metabolic response in postmenopausal women: A randomized acute study. Diabetes Care 2016;39:130-138 http://www.ncbi.nlm.nih.gov/pubmed/26628415

Thorp AA, Kingwell BA, Sethi P, Hammond L, Owen N, Dunstan DW: Alternating bouts of sitting and standing attenuate postprandial glucose responses. Med Sci Sports Exerc 2014;46:2053-2061 http://www.ncbi.nlm.nih.gov/pubmed/24637345

Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, Bertovic DA, Zimmet PZ, Salmon J, Owen N: Breaking up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes Care 2012;35:976-983 http://www.ncbi.nlm.nih.gov/pubmed/22374636

Larsen RN, Kingwell BA, Robinson C, Hammond L, Cerin E, Shaw JE, Healy GN, Hamilton MT, Owen N, Dunstan DW: Breaking up of prolonged sitting over three days sustains, but does not enhance, lowering of postprandial plasma glucose and insulin in overweight and obese adults. Clin Sci (Lond)

33







2015;129:117-127http://www.ncbi.nlm.nih.gov/pubmed/25731923

van Dijk JW, Venema M, van Mechelen W, Stehouwer CD, Hartgens F, van Loon LJ: Effect of moderate-intensity exercise versus activities of daily living on 24-hour blood glucose homeostasis in male patients with type 2 diabetes. Diabetes Care 2013;36:3448-3453http://www.ncbi.nlm.nih.gov/pubmed/24041682

Dempsey PC, Larsen RN, Sethi P, Sacre JW, Straznicky NE, Cohen ND, Cerin E, Lambert GW, Owen N, Kingwell BA, Dunstan DW: Benefits for type 2 diabetes of interrupting prolonged sitting with brief bouts of light walking or simple resistance activities. Diabetes Care 2016;39(6):964-72 http://www.ncbi.nlm.nih.gov/pubmed/27208318

Daily exercise, or at least not allowing more than two days to elapse between exercise sessions, is recommended to enhance insulin action in people with type 2 diabetes. B

Magkos F, Tsekouras Y, Kavouras SA, Mittendorfer B, Sidossis LS: Improved insulin sensitivity after a single bout of exercise is curvilinearly related to exercise energy expenditure. Clin Sci (Lond) 2008;114:59-64

34










Gillen JB, Little JP, Punthakee Z, Tarnopolsky MA, Riddell MC, Gibala MJ: Acute high-intensity interval exercise reduces the postprandial glucose response and prevalence of hyperglycaemia in patients with type 2 diabetes. Diabetes Obes Metab 2012;14:575-577 http://www.ncbi.nlm.nih.gov/pubmed/22268455

Newsom SA, Everett AC, Hinko A, Horowitz JF: A single session of low-intensity exercise is sufficient to enhance insulin sensitivity into the next day in obese adults. Diabetes Care 2013;36:2516-2522 http://www.ncbi.nlm.nih.gov/pubmed/23757424

Structured lifestyle interventions that include at least 150 min/week of physical activity and dietary changes resulting in weight loss of 5−7% are recommended to prevent or delay the onset of type 2 diabetes in high-risk and prediabetic populations.

Erika: Belongs in prevention section? Use of “prediabetic”?

Chen L, Pei JH, Kuang J, Chen HM, Chen Z, Li ZW, Yang HZ: Effect of lifestyle intervention in patients with type 2 diabetes: A meta-analysis. Metabolism 2015;64:338-347 http://www.ncbi.nlm.

35

A nih.gov/pubmed/25467842

Lin X, Zhang X, Guo J, Roberts CK, McKenzie S, Wu WC, Liu S, Song Y: Effects of exercise training on cardiorespiratory fitness and biomarkers of cardiometabolic health: A systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc 2015;4 http://www.ncbi.nlm.nih.gov/pubmed/26116691

Schellenberg ES, Dryden DM, Vandermeer B, Ha C, Korownyk C: Lifestyle interventions for patients with and at risk for type 2 diabetes: A systematic review and meta-analysis. Ann Intern Med 2013;159:543-551 http://www.ncbi.nlm.nih.gov/pubmed/24126648

36

Yardley JE, Hay J, Abou-Setta AM, Marks SD, McGavock J: A systematic review and meta-analysis of exercise interventions in adults with type 1 diabetes. Diabetes Res Clin Pract 2014;106:393-400 http://www.ncbi.nlm.nih.gov/pubmed/25451913

Youth and adults with type 1 diabetes can benefit from being physically active, and activity should be recommended to all. B

Yardley JE, Hay J, Abou-Setta AM, Marks SD, McGavock J: A systematic review and meta-analysis of exercise interventions in adults with type 1 diabetes. Diabetes Res Clin Pract 2014;106:393-400


Blood glucose responses to physical activity in all with type 1 diabetes are highly variable based on activity type/timing and require different adjustments. B

Yardley JE, Hay J, Abou-Setta AM, Marks SD, McGavock J: A systematic review and meta-analysis of exercise

37

interventions in adults with type 1 diabetes. Diabetes Res Clin Pract 2014;106:393-400


Most adults with type 1 (C) and type 2 (B) diabetes should engage in 150 min or more of moderate-to-vigorous intensity activity weekly, spread over at least 3 days/week, with no more than 2 consecutive days without activity. Shorter durations (minimum 75 minutes/week) of vigorous-intensity or interval training may be sufficient for younger and more physically fit individuals.

Type 2: Many prior refs (not included in PS, but can use 2010 PS on T2D as ref: http://www.ncbi.nlm.nih.gov/pubmed/21115758)

Jelleyman C, Yates T, O'Donovan G, Gray LJ, King JA, Khunti K, Davies MJ: The effects of high-intensity interval training on glucose regulation and insulin resistance: A meta-analysis. Obes Rev 2015;16:942-961 http://www.ncbi.nlm.nih.gov/pubmed/26481101

Type 1:Tonoli C, Heyman E, Roelands B, Buyse L, Cheung SS, Berthoin S, Meeusen R: Effects of different types of acute and chronic (training) exercise on glycaemic control in type 1 diabetes mellitus: A meta-analysis. Sports Med 2012;42:1059-1080 http://www.ncbi.nlm.nih.gov/pubmed/23134339

Children and Include in Physical Activity

38

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

children/adolescent section?

Guidelines Advisory Committee: Physical activity guidelines advisory committee report, 2008. Washington, DC, U.S.Department of Health and Human Services, 2008, p. 683 https://health.gov/Paguidelines/Report/pdf/CommitteeReport.pdf

Adults with type 1 (C) and type 2 (B)diabetes should engage in 2−3 sessions/week of resistance exercise on non-consecutive days.

Type 2: Willey KA, Singh MA: Battling insulin resistance in elderly obese people with type 2 diabetes: Bring on the heavy weights. Diabetes Care 2003;26:1580-1588 http://www.ncbi.nlm.nih.gov/pubmed/12716822

Type 1:Physical Activity Guidelines Advisory Committee: Physical activity guidelines advisory committee report, 2008. Washington, DC, U.S.Department of Health and Human Services, 2008, p. 683 https://health.gov/Paguidelines/Report/pdf/

39

CommitteeReport.pdf

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

Include in older adults section?

Herriott MT, Colberg SR, Parson HK, Nunnold T, Vinik AI: Effects of 8 weeks of flexibility and resistance training in older adults with type 2 diabetes. Diabetes Care 2004;27:2988-2989 http://www.ncbi.nlm.nih.gov/pubmed/15562222

Morrison S, Colberg SR, Mariano M, Parson HK, Vinik AI: Balance training reduces falls risk in older individuals with type 2 diabetes. Diabetes Care 2010;33:748-750 http://www.ncbi.nlm.nih.gov/pubmed/20097781

Innes KE, Selfe TK: Yoga for adults with type 2 diabetes: A systematic review of controlled trials. J Diabetes Res 2016;2016:6979370 http://www.ncbi.nlm.nih.gov/pubmed/26788520

Ahn S, Song R: Effects of tai chi exercise on glucose

40

control, neuropathy scores, balance, and quality of life in patients with type 2 diabetes and neuropathy. J Altern Complement Med 2012;18:1172-1178 http://www.ncbi.nlm.nih.gov/pubmed/22985218

Females with pre-existing diabetes of any type should be advised to engage in regular physical activity prior to and during pregnancy. C

Move to pregnancy section?

Gynecology ACoOa: Acog committee opinion no. 650: Physical activity and exercise during pregnancy and the postpartum period. Obstet Gynecol 2015;126:e135-142 http://www.ncbi.nlm.nih.gov/pubmed/26595585

Sanabria-Martinez G, Garcia-Hermoso A, Poyatos-Leon R, Alvarez-Bueno C, Sanchez-Lopez M, Martinez-Vizcaino V: Effectiveness of physical activity interventions on preventing gestational diabetes mellitus and excessive maternal weight gain: A meta-analysis. Bjog 2015;122:1167-1174 http://www.ncbi.nlm.nih.gov/pubmed/26036300

Russo LM, Nobles C, Ertel KA, Chasan-Taber L, Whitcomb BW:

41

Physical activity interventions in pregnancy and risk of gestational diabetes mellitus: A systematic review and meta-analysis. Obstet Gynecol 2015;125:576-582 http://www.ncbi.nlm.nih.gov/pubmed/25730218

While a program of physical activity can be safe for all individuals, a detailed assessment of risk should be conducted to minimize adverse events related to hypoglycemia or exacerbating complications.

Evidence level?? Refer to new position statement

Advise all patients not to use cigarettes, other tobacco products, or e-cigarettes. A

97 – 104

Add new articles to this group – showing smoking is a greater risk than obesity for MI.

http://jama.jamanetwork.com/article.aspx?articleid=1667090

This article 2013 – supports the benefits of smoking cessation in spite of wt gain.

And new one: 2016http://www.ejinme.com/article/S0953-6205(16)30049-8/abstract

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

Sleep consultant for next year.

Prevention or Delay of Type 2 DiabetesNothing in prior Standards of Care (new item)

(Poltavskiy E et al. Diabetes Res Clin Pract (2016))

42




//Note from Erika: Needs to be rewritten as recommendation//

Should this be here or in chapter 2 (noted above as comment about adding ADA risk test above)

Move this above.

Delete here, reference above.

Validated risk factor screening tools may be useful to identify persons at risk for Prediabetes and Diabetes (C)

Bang H et al. Ann Intern Med. 2009 Dec 1;151(11):775-83. doi: 10.7326/0003-4819-151-11-200912010-00005.

Herman WH et al. Diabetes Care. 1995 Mar;18(3):382-7.

Siu AL; U S Preventive Services Task Force.Ann Intern Med. 2015 Dec 1;163(11):861-8. doi: 10.7326/M15-2345. Epub 2015 Oct 27Screening for Abnormal Blood Glucose and Type 2 Diabetes Mellitus: U.S. Preventive Services Task Force Recommendation Statement. [Ann Intern Med. 2015].

Patients with prediabetes should be referred to an intensive diet and physical activity behavioral counseling program adhering to the tenets of the Diabetes Prevention Program (DPP) targeting a loss of 7% of body weight and should increase their moderate-intensity physical activity (such as brisk walking) to at least 150 min/week. A

Good new ref:

Ackermann RT et al. Am J Public Health. 2015 Nov;105(11):2328-34. doi: 10.2105/AJPH.2015.302641. Epub 2015 Sep 17.

Eating patterns and foods associated with diabetes prevention

EVIDENCE LEVEL? PLoS Med. 2016 Jun 14;13(6):e1002039. doi: 10.1371/journal.pmed.1002039. eCollection 2016.

43

should be encouraged including Mediterranean, Plant based, DASH, and high quality diets including whole grains, diary, nuts, and green leafy vegetables.

Plant-Based Dietary Patterns and Incidence of Type 2 Diabetes in US Men and Women: Results from Three Prospective Cohort Studies.Satija A1 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4907448/

Circulation. 2016 Jan 12;133(2):187-225. doi: 10.1161/CIRCULATIONAHA.115.018585.Dietary and Policy Priorities for Cardiovascular Disease, Diabetes, and Obesity: A Comprehensive Review.Mozaffarian D1 .http://circ.ahajournals.org/content/133/2/187.long

http://www.ncbi.nlm.nih.gov/pubmed/?term=ley+hamdyLey SH et al. Prevention and Mangement of type 2 diabetse: dietary components and nutritional strategies. Lancet Vol 383 June 7 2014

Follow-up counseling and maintenance programs should be offered for long-term success in preventing diabetes. B

Replace old references with newer, more comprehensive ones

replace (8) with Li G et al. Lancet Diabetes Endocrinol. 2014 Jun;2(6):474-80. doi: 10.1016/S2213-8587(14)70057-9. Epub 2014 Apr 3.Replace (9) with Lindström J et al. Diabetologia. 2013 Feb;56(2):284-93. doi: 10.1007/s00125-012-

44

http://www.ncbi.nlm.nih.gov/pubmed/?term=ley+hamdy



http://circ.ahajournals.org/content/133/2/187.long






2752-5. Epub 2012 Oct 24.Replace 13 withAckermann RT et al. Chronic Illn. 2011 Dec;7(4):279-90. doi: 10.1177/1742395311407532. Epub 2011 Aug 12

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

May cite CMS announcement and analysis on which it was based for DPP, and use Medicare's intensive behavioral therapy for obesity: an exploratory cost-effectiveness analysis. Hoerger TJ et al. Am J Prev Med. 2015 Apr;48(4):419-25. doi: 10.1016/j.amepre.2014.11.008. Epub 2015 Feb 20.

As an alternative to lifestyle therapy, mMetformin is recommended to therapy for prevention of type 2 diabetes should be considered in those with prediabetes, especially in those with if BMI 35 kg/m2, age isthose aged 60 years, or inand women with prior gestational diabetes mellitus. A Monitoring of Vitamin B12 levels should be considered for those in whom metformin is prescribed C/E.

Check the language here—is metformin only recommended for these populations? What about metformin for people who don’t meet these criteria

Add a caveat to metformin B12 rec? (only in those with symptoms of neuropathy, etc.)

Package insert says to monitor?

Lifestyle and Metformin Ameliorate Insulin Sensitivity Independently of the Genetic Burden of Established Insulin Resistance Variants in Diabetes Preventio n Program Participants. Hivert MF et al Diabetes. 2016 Feb;65(2):520-6. doi: 10.2337/db15-0950. Epub 2015 Nov 2.

Long-term Metformin Use and Vitamin B12 Deficiency in the Diabetes Preventi on Program Outcomes Study.

45

Aroda VR et al Diabetes Prevention Program Research Group. J Clin Endocrinol Metab. 2016 Apr;101(4):1754-61. doi: 10.1210/jc.2015- 3754. Epub 2016 Feb 22.

Association of Biochemical B12 Deficiency With Metformin Therapy and Vitamin B12 Supplements. Reinstatler L et al Diabetes Care 2012 Feb; 35(2): 327-333.

At least annual monitoring for the development of diabetes in those with prediabetes is suggested. EScreening for and treatment of modifiable risk factors for cardiovascular disease is suggested. B

H. Feldman still working on pulling articles.

Diabetes self-management education and support programs are appropriate venues for people with prediabetes to receive education and support to develop and maintain behaviors that can prevent or delay the onset of diabetes. BTechnology-assisted tools including Internet-based social networks, distance learning, DVD-based content, and mobile applications can

Include reference to Omada health’s research cited above in Education section –http://www.jmir.org/2015/4/e92/

46



be useful in preventing diabetes and/or enhancing the effectiveness of existing programs. elements of effective lifestyle modification to prevent diabetes. B

article by Sepah et al (including Anne Peters) on 2 yr online DM prevention program.

Will find more. The studies are pilot in nature, but are emerging. Several online/mobile versions of DPP, for example, are now listed on the CDC’s DPRP site. CMS will potentially reimburse for the use of these, as long as engagement can be documented and weight loss goals are achievable.

Assessment of Glycemic ControlWhen prescribed as part of a broader educational context, self-monitoring of blood glucose (SMBG) results may help to guide treatment decisions and/or self-management for patients using less frequent insulin injections B or non-insulin therapies. E


1-14

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 references currently cited in 2016 standards (supported by narrative)

Most patients on intensive insulin regimens (multiple-dose insulin or insulin pump therapy) should consider SMBG prior to meals and snacks, occasionally postprandially, at

No Change

47

bedtime, 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. BWhen 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


15, 20

Although the evidence for A1C lowering is less strong in children, teens, and younger adults, CGM may be helpful in these groups. Success correlates with adherence to ongoing use of the device. B


16-20,23

CGM may be a supplemental tool to SMBG in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes. C


Need to add/modify a recommendation if the FDA approves non-ancillary use of Dexcom G5?

Add information to text?

20-22 For Discussion (Dr. Ratner?):

Endocrine Today Article

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


16,24

When prescribing CGM, robust diabetes


16,24

48

http://www.healio.com/endocrinology/diabetes/news/online/%7Bb12bad90-c726-4632-8083-0d6fe05fd636%7D/fda-advisory-panel-recommends-cgm-as-replacement-for-smbg

education, training, and support are required for optimal CGM implementation and ongoing use. EPeople who have been successfully using CGM should have continued access after they turn 65 years of age. E



Herman WH, Ilag LL, Johnson SL, et al. A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. Diabetes Care 2005;28:1568–1573

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



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

No Change Currently Recommended.

Need to modify if POC A1C testing granted as diagnostic by FDA?

No references currently cited in 2016 standards.

Added a sentence to make note of POC testing within this subsection.

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


32-37, 53

Providers might reasonably suggest more stringent A1C goals (such as <6.5% [48 mmol/mol]) for selected individual patients if this can be achieved without significant


34-37; Supported by narrative

49




hypoglycemia or other adverse effects of treatment. 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. CLess 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 attain despite diabetes self-management education, appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents including insulin. B


38-53

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


Not explicitly mentioned in the narrative within this section.

Hypoglycemia recommendations to be reviewed when ADA/EASD joint position statement available

Glucose (15–20 g) is the preferred treatment for the conscious individual with hypoglycemia,



Hypoglycemia recommendations to be reviewed when ADA/EASD joint position

50

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

Added sentence in narrative to make note of consuming a meal or snack per the recommendation.

statement available

Glucagon should be prescribed for all individuals at increased risk of severe hypoglycemia, defined as hypoglycemia requiring assistance, and caregivers, school personnel, or family members of these individuals should be instructed in its administration. Glucagon administration is not limited to health care professionals. E

No Change Recommended.Change to align with hypo statement



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


Align with hypo (remove severe)

62; Supported by narrative


Insulin-treated patients with hypoglycemia unawareness or an episode of severe hypoglycemia should be advised to raise their glycemic targets to


62 Hypoglycemia recommendations to be reviewed when ADA/EASD joint position statement available

51

strictly avoid further hypoglycemia for at least several weeks in order to partially reverse hypoglycemia unawareness and reduce risk of future episodes. AOngoing 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


56,57 Hypoglycemia recommendations to be reviewed when ADA/EASD joint position statement available

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


12

Diet, physical 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


13-16 Steven et al. Very-low-calorie diet and 6 months of weight stability in type 2 diabetes: Pathophysiologic changes in responders and nonresponders. Diabetes Care March 21, 2016. Epub Ahead of Print.

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


Franz article 2015 JAND


Diets that provide the same caloric restriction but differ in protein, carbohydrate, and fat


13-16

52




content are equally effective in achieving weight loss. AFor patients who achieve short-term weight loss goals, long-term (1-year) comprehensive 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


18

To achieve weight loss of >5%, short-term (3-month) high-intensity lifestyle 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


Text should address meal replacement outcomes

19-20 Meal replacement article:

Shows high quality of diets in T2 DM consuming meal replacements

Raynor H et al. JAND. 2015; 115:731-

When choosing glucose-lowering medications for overweight or obese patients with type 2



53

diabetes, consider their effect on weight. EWhenever possible, minimize the medications for comorbid conditions that are associated with weight gain. E



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


21-23

If a patient’s response to weight loss medications is <5% 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


21-23

Bariatric or metabolic surgery may be considered for adults with BMI >35 kg/m2 and type 2 diabetes, especially if diabetes or associated comorbidities are difficult to control with lifestyle and pharmacological therapy. Bshould be recommended to treat type 2 diabetes in appropriate surgical

Revised per Rubino 2016.

Change bariatric to metabolic—address in text why we are doing that.

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

54




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 patients with BMI 35.0-39.9 kg/m2 (32.5-37.4 kg/m2 in Asian Americans) when hyperglycemia is inadequately controlled despite lifestyle and optimal medical therapy. AMetabolic surgery should be considered for patients with T2DM and BMI 30.0-34.9 kg/m2 (27.5-32.4 kg/m2 in Asian Americans) if hyperglycemia is inadequately controlled despite optimal treatment with oral and/or injectable medications (including insulin). B

New Suggested Recommendation

8,9,38,39 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

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

New Suggested Recommendation

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

Patients with type 2 diabetes who have undergone bariatric surgery need lifelong lifestyleLong-term support and annual medical monitoring, at

Revised per Rubino 2016.

Rubino et al. Metabolic Surgery in the treatment algorithm for type 2 diabetes: A joint statement by international diabetes organizations. Diabetes

55










a minimum of micronutrient and nutritional status must be provided to patients after surgery, according to guidelines for postoperative management of bariatric/metabolic surgery by national and international professional societies. CB

Care 2016;39:861-877

Persons presenting for metabolic surgery, should receive a comprehensive mental health assessment that includes health related quality of life and eating cognitions and behaviors by a professional familiar weight loss interventions and post-bariatric surgery behavioral requirements. BIf psychopathology is evident, particularly suicidal ideation and/or significant depression, postponement of surgery should be considered so that patient suffering can be addressed before adding the burden of recovery and lifestyle/psychosocial adjustment. EPersons who undergo bariatric surgery should be assessed for need of ongoing mental health services to help them adjust to medical and

56

psychosocial changes post-surgery.C

Although small trials have shown a glycemic benefit of bariatric surgery in patients with type 2 diabetes and BMI 30–35 kg/m2, there is currently insufficient evidence to generally recommend surgery in patients with BMI ≤35 kg/m2. E

Recommend to delete recommendation per changes to above recommendations.

Pharmacologic Approaches To Glycemic TreatmentInclude advocacy recommendation about access to medications that are best for an individual patient (model on CGM recommendation)

Run anything by Bob, Shareen,***

Most people with type 1 diabetes should be treated with multiple-dose insulin injections (three to four injections per day of basal and prandial insulin) or continuous subcutaneous insulin infusion. A


Recommended change to current reference #12 (delete current reference #12 and replace with Bode et al.) and narrative related to inhaled prandial insulin in T1DM.

2-6,8,9 Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. Mortality in Type 1 diabetes in the DCCT/EDIC versus the general population. Diabetes Care 2016;39(8):1378-1383

Bode, BW, McGill JB, Lorber DL, et al. Inhaled technosphere insulin compared with injected prandial insulin in type 1 diabetes: A randomized 24-week trial. Diabetes Care 2015;38:2266-2273

Consider educating individuals with type 1 diabetes on matching


No references currently cited in 2016 standards (supported by

57




prandial insulin dose to carbohydrate intake, premeal blood glucose, and anticipated activity. E

narrative)

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


Individuals who have been successfully using continuous subcutaneous insulin infusion should have continued access after they turn 65 years of age. E


30 (Not specifically discussed in the narrative within the T1DM section)

Added text for consideration regarding this expert opinion recommendation such that it was mentioned in the narrative in the T1DM section.

Metformin, if not contraindicated and if tolerated, is the preferred initial pharmacological agent for type 2 diabetes. A


17,18 Aroda VR, Edelstein SL, Goldberg RB, et al. Long-term metformin use and vitamin B12 deficiency in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab 2016;101:1754-1761

US Food and Drug Administration (FDA) MedWatch for Metformin-containing Drugs: Revised Warnings for Certain Patients with Reduced Kidney Function. Website Link.

Long-term use of metformin may be associated with biochemical B12 deficiency, and routine measurement of vitamin B12 levels in metformin-treated patients

Long-term Metformin Use and Vitamin B12 Deficiency in the Diabetes Prevention Program Outcomes Study

58

https://urldefense.proofpoint.com/v2/url?u=http-3A__www.ncbi.nlm.nih.gov_pubmed_26900641&d=CwMFAg&c=qS4goWBT7poplM69zy_3xhKwEW14JZMSdioCoppxeFU&r=5y4e2iMOuFQJd_z8MMSwMfYGUo2KNVn7Ks8eQRvc_pMdiaH8SHBBGWeuP4O0hJ7A&m=F3MTwLcxmbBtEt7-c2UhhiQa623U8Vt5_JEIDlgAWWs&s=acA4pyTksUdZzK91NCDmS2xFxQ3OLfgHWhOrIwNzNus&e=



http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494829.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery




should be considered BConsider initiating insulin therapy (with or without additional agents) in patients with newly diagnosed type 2 diabetes and markedly symptomatic and/or elevated blood glucose levels or A1C. E


17

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


Added text to narrative and reference in Table 1 related to EMPA-REG OUTCOME and LEADER results.

Added IRIS study to Table 1.

Created draft tables for pricing on: 1) non-insulin agents; and 2) insulin products (separate attachments).

Add footnote to make clear that price to consumers may vary

17, 27 Giugliano, D, Chiodini P, Maiorino MI, et al. Intensification of insulin therapy with basal-bolus or premixed insulin regimens in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Endocrine 2016;51:417-428

Zinman B, Wanner C, Lachin JM, et al.; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015;373:2117-2128

Marso SP, Daniels GH, Brown-Frandsen K, et al.; LEADER Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016;375(4):311-322

Kernan WN, Viscoli CM, Furie KL, et al. Pioglitazone after

59











ischemic stroke or transient ischemic attack. N Engl J Med 2016;374:1321-1331

A patient-centered approach should be used to guide the choice of pharmacological agents. Considerations include efficacy, cost, potential side effects, weight, comorbidities, hypoglycemia risk, and patient preferences. E


For discussion: Should CV benefit be added to recommendation and Figure 7.1 per recent CVOT results (EMPA-REG, LEADER, etc.)?

Add section on biosimilars to text.

17,20,22,23,24 Palmer SC, Mavridis D, Nicolucci A, et al. Comparison of clinical outcomes and adverse events associated with glucose-lowering drugs in patients with type 2 diabetes: A meta-analysis. JAMA 2016;316(3):313-324

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


17

Cardiovascular Disease and Risk ManagementBlood 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

No change

People Most patients with diabetes and hypertension should be treated to a systolic blood pressure goal of <140 mmHg and a diastolic blood pressure goals of <90 mmHg. A

Acknowledge options for individualization below

Lower systolic targets, such as <125-130 mmHg, may be appropriate for certain individuals with diabetes who have diastolic blood

Add stroke information,

Is 60 mmHg right? Too low? Delete callout of 60 mmHg—add to text, subsumed by undue treatment burden, or

60






pressures consistently above 60 mmHg, high, such as younger patients, those with albuminuria, and/or those with hypertension and one or more additional atherosclerotic cardiovascular disease risk factors, atherosclerotic cardiovascular risk, or more than 300 mg/day of albuminuria, if they can be achieved without undue treatment burden. C

add “including undue lowering of diastolic.”

Make sure this is consistent with recommendation in the DKD section

Individuals with diabetes should be treated to a diastolic blood pressure goal of <90 mmHg. A

Merged with above

Lower diastolic targets, such as <80 mmHg, may be appropriate for certain individuals with diabetes, such as younger patients, those with albuminuria, and/or those with hypertension and one or more additional atherosclerotic cardiovascular disease risk factors, if they can be achieved without undue treatment burden. BC

Level of evidence downgraded, consistent with SBP individualization. Much debate about whether both should be B or C among HTN group.

Lifestyle therapy for pPatients with blood pressure >120/80 mmHg consists of weight loss, if overweight or obese; a Dietary Approaches to Stop Hypertension

Merged with subsequent lifestyle rec

Move this below the next bullet?

61

(DASH)-style dietary pattern including reducing sodium and increasing potassium intake as long as the eGFR is above 45 ml/min/ 1.73m2 ; moderation of alcohol intake; and increased physical activityshould be advised on lifestyle changes to reduce blood pressure. BPatients with confirmed office-based blood pressure >140/90 mmHg should, in addition to lifestyle therapy, have prompt initiation and timely subsequent titration of pharmacological therapy to achieve blood pressure goals. A

No change

In older adults, pharmacological therapy to achieve treatment goals of < 130/70 mmHg is not recommended; treating to systolic blood pressure <130 mmHg has not been shown to improve cardiovascular outcomes and treating to diastolic blood pressure <70 mmHg has been associated with higher mortality. C

To text in context of individualization

Lifestyle therapy for elevated blood pressure consists of weight loss, if overweight or obese; a Dietary Approaches to Stop Hypertension (DASH)-style dietary pattern including

Merged with above

62

reducing sodium and increasing potassium intake; moderation of alcohol intake; and increased physical activity. BPharmacological therapy for patients with diabetes and hypertension should comprise a regimen that includes either an ACE inhibitor or an angiotensin receptor blocker but not both. B If one class is not tolerated, the other should be substituted. CInitial drug therapy for those with a blood pressure >140/90 mmHg should be with a drug class demonstrated to reduce CVD events in patients with diabetes (ACE inhibitors or ARBs or thiazide-like diuretics or dihydropyridine calcium channel blockers) or, if confirmed office blood pressures >160/100 mmHg, with a single pill combination of drugs demonstrated to reduce CVD events in patients with diabetes. A

Acknowledge new evidence that ACEI or ARB not necessarily superior in absence of DKD

Add this back in?: If one class is not tolerated, the other should be substituted. C

Include information here about—in the absence of kidney disease—or something?

Highlight role of thiazides/calcium channel blockers in African Americans?

Cherrington working with JNC writing group—put this past them to see if they are consistent.

Reword to (Rita)

ACE and ARB should be used in those with albuminuria, and may be used in others

Then other classes may be used in those without kidney disease.

Keep single pill discussion out of it—too specific for Standards

63

Patients with urinary albumin excretion > 300 mg/day should be treated with either an ACE inhibitor or an ARB as part of their antihypertensive regiment. (A)

Added based on clear trials evidence* Need to synch with microvascular rec?

Multiple-drug therapy (including a thiazide diuretic and ACE inhibitor/angiotensin receptor blocker, at maximal doses) is generally required to achieve blood pressure targets. B

To text

If ACE inhibitors, angiotensin receptor blockers, or diuretics are used, serum creatinine/estimated glomerular filtration rate and serum potassium levels should be monitored. EB

Increased level of evidence

Trials demonstrating AKI and hyperkalemia with intensive BP control, associations of AKI and hyperkalemia with adverse outcomes

Patients with resistant hypertension who have failed conventional drug therapy with three agents, including a diuretic, and/or with a significant renal disease should be referred to a physician experienced in the care of patients with hypertension certified hypertension specialist or someone with experience with resistant hypertension. E

Consider adding vs in hypertension position statement only

Stay in statement, don’t include in Standards

Patients with resistant hypertension who have failed conventional drug

New data on effectiveness of spironolactone for BP

64

therapy with three agents should be considered for mineral corticocoid receptor antagonist therapy B

control and finerenone for albuminuria reduction

Stay in statement, not in Standards

In pregnant patients with diabetes and chronic hypertension, blood pressure targets of 120–160/80–105110–129/65–79 mmHg are suggested in the interest of optimizing long-term maternal health and minimizing impaired fetal growth. E

Consistent with ACOG guidelines, concerns regarding fetal perfusion at low BPs

Don Coustan comment?

In adults not taking statins, it is reasonable to obtain a lipid profile at the time of diabetes diagnosis, at an initial medical evaluation, and every 5 years thereafter, or more frequently if indicated. EObtain a lipid profile at initiation of statin therapy and periodically thereafter as it may help to monitor the response to therapy and inform adherence. ELifestyle modification focusing on weight loss (if indicated); the reduction of saturated fat, trans fat, and dietary cholesterol intake; increase of omega-3 fatty acids, viscous fiber, and plant stanols/sterols intake; and increased physical

Is cholesterol recommendation still true? cite studies on lack of evidence for dietary supplements

65

activity should be recommended to improve the lipid profile in patients with diabetes. AIntensify 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). CFor 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. CFor patients of all ages with diabetes and atherosclerotic cardiovascular disease, high-intensity statin therapy should be added to lifestyle therapy. AFor patients with diabetes aged <40 years with additional atherosclerotic cardiovascular disease risk factors, consider using moderate-intensity or high-intensity statin and lifestyle therapy. CFor patients with diabetes aged 40–75 years without additional atherosclerotic

66

cardiovascular disease risk factors, consider using moderate-intensity statin and life-style therapy. AFor patients with diabetes aged 40–75 years with additional atherosclerotic cardiovascular disease risk factors, consider using high-intensity statin and lifestyle therapy. BFor patients with diabetes aged >75 years without additional atherosclerotic cardiovascular disease risk factors, consider using moderate-intensity statin therapy and lifestyle therapy. BFor 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. BIn 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). EThe addition of ezetimibe to moderate-intensity statin therapy has been shown to provide additional

Refer to comment to SOC 2016

67

cardiovascular benefit compared with to moderate-intensity statin therapy alone and may be considered for patients with a recent acute coronary syndrome with LDL cholesterol 50 mg/dL (1.3 mmol/L) or for those patients who cannot tolerate high-intensity statin therapy. ACombination 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). BCombination therapy (statin/niacin) has not been shown to provide additional cardiovascular benefit above statin therapy alone and may increase the risk of stroke and is not generally recommended. AStatin therapy is contraindicated in pregnancy. BConsider aspirin therapy (75–162 mg/day) as a primary

The risk calculators have not been as well validated in diabetes

Low-Dose Aspirin in the Primary Prevention of Cardiovascular Disease: Shared

68

prevention strategy in those with type 1 or type 2 diabetes who are at increased cardiovascular risk (10-year risk >10%). This includes most men or women with diabetes aged 50 years who have at least one additional major riskfactor (family history of premature atherosclerotic cardiovascular disease, hypertension, smoking, dyslipidemia, or albuminuria) and are not at increased risk of bleeding. C

and we don’t emphasize them in the rest of the SOC.

Decision Making in Clinical Practice

Samia Mora, MD, MHS;

Jeffrey M. Ames, BS,

MEng; JoAnn

E. Manson, MD, DrPH

JAMA. Published online

June 20, 2016.

doi:10.1001/jama.2016.83

62

In Vivo Platelet Activation and Aspirin Responsi veness in Type 1 Diabetes . Zaccardi F, Rizzi A, Petrucci G, Ciaffardini F, Tanese L, Pagliaccia F, Cavalca V, Ciminello A, Habib A, Squellerio I, Rizzo P, Tremoli E, Rocca B, Pitocco D, Patrono C.Diabetes. 2016 Feb;65(2):503-9. doi: 10.2337/db15-0936. Epub 2015 Oct 15.

PMID: 26470782

Value of Coronary Computed Tomography Angiography in Tailoring Aspirin Ther apy for Primary Prevention of Atherosclerotic Events in Patients at High Risk With Diabetes Mellitu s.Dimitriu-Leen AC, Scholte AJ, van

69




Rosendael AR, van den Hoogen IJ, Kharagjitsingh AV, Wolterbeek R, Knuuti J, Kroft LJ, Delgado V, Jukema JW, de Graaf MA, Bax JJ.Am J Cardiol. 2016 Mar 15;117(6):887-93. doi: 10.1016/j.amjcard.2015.12.023. Epub 2015 Dec 30.

Aspirin should not be recommended for atherosclerotic cardiovascular disease prevention for adults with diabetes at low atherosclerotic cardiovascular disease risk (10- year atherosclerotic cardiovascular disease risk <5%), 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

The risk calculators have not been as well validated in diabetes and we don’t emphasize them in the rest of the SOC.

In patients with diabetes <50 years of age with multiple other risk factors (e.g., 10-year risk 5–10%), clinical judgment is required. E

The risk calculators have not been as well validated in diabetes and we don’t emphasize them in the rest of the SOC.

Use aspirin therapy (75–162 mg/day) as a

No change

70

secondary prevention strategy in those with diabetes and a history of atherosclerotic cardiovascular disease. AFor 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

In patients with diabetes with prior MI (1-3 years prior), adding ticagrelor to aspirin significantly reduces the risk of recurrent ischemic events, including cardiovascular and coronary heart disease death

Reduction in Ischemic Events With Ticagrelor in Diabetic Patients With Prior Myocardial Infarction in PEGASUS-TIMI 54.Bhatt DL, Bonaca MP, Bansilal S, Angiolillo DJ, Cohen M, Storey RF, Im K, Murphy SA, Held P, Braunwald E, Sabatine MS, Steg PG.J Am Coll Cardiol. 2016 Jun 14;67(23):2732-40. doi: 10.1016/j.jacc.2016.03.529. Epub 2016 Apr 1.

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. AConsider investigations for coronary artery

71




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). EIn patients with known atherosclerotic cardiovascular disease, use aspirin and statin therapy (if not contraindicated) A and consider ACE inhibitor therapy C to reduce the risk of cardiovascular events.In patients with prior myocardial infarction, -blockers should be continued for at least 2 years after the event. BIn patients with symptomatic heart failure, thiazolidinedione treatment should not be used. A? positive statement about empaliflozin

Empagliflozin and liraglutide may be considered as particularly effective in people with CVD to

Should we include a positive statement about empagliflozin?

In text—highlight the status of data on diabetes meds overall, things may change as new trial data becomes

72

minimize further vascular and renal events.A

available

Bill will draft recommendation and text for the group to decide.

See this article?Eli Lilly & Co and Boehringer Ingelheim should be allowed to claim that their diabetes drug Jardiance cuts the risk of cardiovascular death, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday.The FDA is not obliged to follow the advice of its advisory committees but typically does so.Jardiance, also known as empagliflozin, was approved in 2014 to help lower blood sugar in patients with type 2 diabetes. The companies are seeking approval to claim that it also cuts the risk of death from heart attacks and strokes.The panelists voted 12-11 to allow the claim that it cuts the risk of cardiovascular death. The panel voted unanimously that it does not add to the risk of cardiovascular problems.

In patients with type 2 diabetes with stable congestive heart failure,

73

http://www.reuters.com/article/us-health-diabetes-eli-lilly-idUSKCN0ZE2MC



metformin may be used if renal function is normal but should be avoided in unstable or hospitalized patients with congestive heart failure. BMirovascular Complications and Foot CareAt 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 with type 2 diabetes, and in all patients with comorbid hypertension. B

No change

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

No change Several to add

Optimize blood pressure control (<140/90 mmHg or lower) to reduce the risk or slow the progression of diabetic kidney disease. A

No change anticipatedAcknowledge individualization

Await HTN statement, include metaanalyses, SPRINT, ADVANCE

For people with nondialysis-dependent diabetic kidney disease, dietary protein intake should be 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. AB

There are no new data here, but NKF and KDIGO consider this lower-grade evidence, and I personally consider it a level B at best

Either an ACE inhibitor or an angiotensin

Specify for hypertension

Add new metaanalyses

74

receptor blocker is recommended for the treatment of nonpregnant patients with diabetes, hypertension, and modestly elevated urinary albumin excretion (30–299 mg/day) B and is strongly recommended for those with urinary albumin excretion 300 mg/day and/or estimated glomerular filtration rate <60 mL/min/1.73 m2. A

* Need to synch with hypertension rec?

Match hypertension statement to match this

Periodically monitor serum creatinine and potassium levels for the development of increased creatinine or changes in potassium when ACE inhibitors, angiotensin receptor blockers, or diuretics are used. EB

No changeUpdgrade level of evidence as in hypertension guideline

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

No change

Add to text: if you are treating with and ACE or ARB for DKD, use maximum dose, if tolerated.

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

Delete? Take out rec and put in text? Keep in

75

normal blood pressure, normal urinary albumin–to–creatinine ratio (<30 mg/g), and normal estimated glomerular filtration rate. BWhen estimated glomerular filtration rate is <60 mL/min/1.73 m2, evaluate and manage potential complications of chronic kidney disease. EPatients should be referred for evaluation for renal replacement treatment if they have estimated glomerular filtration rate <30 mL/min/1.73 m2. APromptly 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. BOptimize glycemic control to reduce the risk or slow the progression of diabetic retinopathy. A

No change Effects of Prior Intensive Insulin Therapy and Risk Factors on Patient-Reported Visual Function Outcomes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventi ons and Complications (DCCT/EDIC) Cohort.Writing Team for the DCCT/EDIC Research Group, Gubitosi-Klug RA,

76




Sun W, Cleary PA, Braffett BH, Aiello LP, Das A, Tamborlane W, Klein R.

Add DCCT:The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. N Engl J Med. 1993;329(14):977–86.

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

No change Comparative effectiveness of angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers in patients with type 2 diabetes and retino pathy . Shih CJ, Chen HT, Kuo SC, Li SY, Lai PH, Chen SC, Ou SM, Chen YT.CMAJ. 2016 May 17;188(8):E148-57. doi: 10.1503/cmaj.150771. Epub 2016 Mar 21.

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. BPatients with type 2 diabetes should have an initial dilated and comprehensive eye

77




examination by an ophthalmologist or optometrist at the time of the diabetes diagnosis. BIf there is no evidence of retinopathy for one or more annual eye exams, then exams every 2 years may be considered. If any level of diabetic retinopathy is present, subsequent dilated retinal examinations for patients with type 1 or type 2 diabetes 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. BWhile retinal photography may serve as a screening tool for retinopathy, it is not a substitute for a comprehensive eye exam, which should be performed at least initially and at intervals thereafter as recommended by an eye care professional. E

No change Evaluation of Automated Teleretinal Screening Program for Diabetic Retinopa thy . Walton OB 4th, Garoon RB, Weng CY, Gross J, Young AK, Camero KA, Jin H, Carvounis PE, Coffee RE, Chu YI.JAMA Ophthalmol. 2016 Feb;134(2):204-9. doi: 10.1001/jamaophthalmol.2015.5083.

Dilated eEye examinations should occur before pregnancy or in the first trimester,

78




and then patients should be monitored every trimester and for 1 year postpartum as indicated by the degree of retinopathy. BPromptly 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. ALaser photocoagulation therapy is indicated to reduce the risk of vision loss in patients with high-risk proliferative diabetic retinopathy and, in some cases, severe nonproliferative diabetic retinopathy. A

No change Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diab etic Retinopathy : A Randomized Clinical Trial.Writing Committee for the Diabetic Retinopathy Clinical Research Network, Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL 3rd, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW.

79




JAMA. 2015 Nov 24;314(20):2137-46. doi: 10.1001/jama.2015.15217

Intravitreal injections of antivascular endothelial growth factor are indicated for center-involved diabetic macular edema, which occurs beneath the foveal center and may threaten reading vision. AThe presence of retinopathy is not a contraindication to aspirin therapy for cardioprotection, as aspirin does not increase the risk of retinal hemorrhage. AAll 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. BAssessment for distal symmetric polyneuropathy should include a careful history and assessment of either temperature or pinprick sensation (small fiber function) and vibration sensation using a 128-Hz tuning fork (large fiber function). All patients should have annual 10-gm monofilament testing to assess for feet at risk for ulceration

Assessment should include a careful history, and a combination of at least two of the following tests: vibration, pinprick, or temperature sensation or 10-g monofilament testing. B

-neuropathy position statement suggestion

This should happen for all patients at all exams

60. Freeman R, Baron R, Bouhassira D, Cabrera J, Emir B: Sensory profiles of patients with neuropathic pain based on the neuropathic pain symptoms and signs. Pain 2014;155:367-376

80

and amputation (see section on foot care, below).Assessment should include a careful history and 10-g monofilament testing and at least one of the following tests: pinprick, temperature, or vibration sensation. B

–rework language to clarify

Symptoms and signs of autonomic neuropathy should be assessed in patients with microvascular and neuropathic complications. E

All patients should be assessed for CAN starting 10 years after diagnosis or in the presence of other forms of diabetic neuropathy and/or other diabetic complications. B

--Wording from the position statement – but PPC subgroup prefers not to change this recommendation

Add specific recommendations in text for how to assess?

(13; 153-157; 161; 167; 169) from neuro statement

Consider gastroparesis in people with diabetic neuropathy, retinopathy, and/or nephropathy by assessing for symptoms of unexpected glycemic variability, early satiety, bloating, nausea, and vomiting, after excluding other causes for these symptoms. C

Neuropathy position statement--In text, add that it can often be asymptomatic

Diabetic kidney disease instead of nephropathy?Include mention of glycemic variability

Additional wordsmithing

Neuro statement references 178, 183, 185, 191

Optimize glucose control to prevent or delay the development of neuropathy in patients with type 1

21. Ismail-Beigi F, et al.: Effect of intensive treatment of hyperglycaemia on microvascular

81

diabetes A and to prevent or slow the progression of neuropathy in patients with type 2 diabetes. B

outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet 2010;376:419-43025. Ang L, et. al: Glucose control and diabetic neuropathy: lessons from recent large clinical trials. Curr Diab Rep 2014;14:52826. Pop-Busui R, et al.: Impact of glycemic control strategies on the progression of diabetic peripheral neuropathy in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Cohort. Diabetes Care 2013;36:3208-3215

Lifestyle interventions are effective forrecommended for the prevention of DSPN prevention in patients with pre-diabetes/metabolic syndrome. B

Change to a level C? Check for RCT.

Change language to be recommended

Move to prevention section—in text, not as recommendation

32. Carnethon MR, Prineas RJ, Temprosa M, Zhang ZM, Uwaifo G, Molitch ME: The association among autonomic nervous system function, incident diabetes, and intervention arm in the diabetes prevention program. Diabetes Care 2006;29:914-91933. Smith AG, Russell J, Feldman EL, Goldstein J, Peltier A, Smith S, Hamwi J, Pollari D, Bixby B,

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Howard J, Singleton JR: Lifestyle intervention for pre-diabetic neuropathy. Diabetes Care 2006;29:1294-1299

Assess and treat patients to reduce pain related to diabetic peripheral neuropathy B and symptoms of autonomic neuropathy and to improve quality of life. EConsider using either pregabalin or duloxetine as theare recommended as the initial approach in the symptomatic treatment for neuropathic pain in diabetes. A

Neuropathy position statement

Strengthen language—these are first line therapies that are recommended.

Neuro statement references 15, 86, 88, 89, 91-96, 98-101

Gabapentin may be also used as an effective initial approach taking into account patients’ socio-economic status, comorbidities, and potential drug interactions. Although not FDA-approved, amitriptyline is also effective for neuropathic pain in diabetes, but should be used with caution given the higher risk of serious side effects. B.


Neither are FDA approved—needs to be moved to text

Broaden amitriptyline to include all tricyclics

Neuro statement references 15, 86, 96, 106, 110

Given the high risks of addiction and other complications, the use of opioids including tapentadol or tramadol is generally not recommended for


Neuro statement reference 15

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treating the pain associated with DSPN. E.Perform a comprehensive foot evaluation at least annuallyeach year to identify risk factors for ulcers and amputations. B

From the statement

We recommend that patients with diabetes undergo annual interval foot inspections by physicians (MD, DO, DPM) or advanced practice providers with training in foot care (Grade 1C).

1)Normal foot: annually2)Peripheral neuropathy: semiannual3)Neuropathy with PAD or deformity: quarterly4) Previous ulcer or amputation: monthly or quarterly

The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine

February 2016Volume 63, Issue 2, Supplement, Pages 3S–21S

http://www.jvascsurg.org/article/S0741-5214(15)02025-X/abstract

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 peripheral vascular disease (leg fatigue, claudication). BThe examination should include inspection of the skin, assessment of foot deformities, neurological assessment including Semmes-Weinstein 10-g monofilament testing and pinprick or

Modify to be consistent with any changes in neuropathy section

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http://www.jvascsurg.org/issue/S0741-5214(15)X0005-X

vibration testing or assessment of ankle reflexes, and vascular assessment including pulses in the legs and feet. BPatients with a history of ulcers or amputations, foot deformities, insensate feet, and peripheral arterial disease are at substantially increased risk for ulcers and amputations and should have their feet examined at every visit. CPatients 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

From the foot care statement:

We suggest that patients with diabetes have ABI measurements performed when they reach 50 years of age (Grade 2C).

They reference our ADA statement:

American Diabetes Association. Peripheral arterial disease in people with diabetes.Diabetes Care. 2003; 26: 3333–3341

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

Should we define multidisciplinary? Why are these examples singled out?

Refer patients who smoke or who have histories of prior lower-extremity complications, loss of protective sensation,

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structural abnormalities, or peripheral arterial disease to foot care specialists for ongoing preventive care and lifelong surveillance. CProvide general foot self-care education to all patients with diabetes. BUse specialized therapeutic footwear in high-risk patients with diabetes including those with severe neuropathy, foot deformities, or history of amputation. B

Should we add a recommendation about use of specialized foot wear?

From the foot care statement:

a.We suggest against the routine use of specialized therapeutic footwear in average-risk diabetic patients (Grade 2C).b.We recommend using custom therapeutic footwear in high-risk diabetic patients, including those with significant neuropathy, foot deformities, or previous amputation (Grade 1B).

Recommended footwear should include a broad and square toe box, laces with three or four eyes per side, padded tongue, quality lightweight materials, and sufficient size to accommodate a cushioned insole.31 In-shoe orthotic inlays are effective in preventing ulceration as assessed by a Cochrane review.32

In one study of 117 patients, custom footwear was successful in reducing peak pressure points in patients at high risk of DFU, but hard outcomes of ulceration were not reported.33 However, a recent large randomized controlled trial (RCT) in 298 high-risk patients with custom orthoses and foot care compared with routine care found a 48% reduction in incident ulcers at 5 years (P < .0001).34

Int J Low Extrem Wounds. 2012 Mar;11(1):59-64. doi: 10.1177/1534734612438729. Epub 2012 Feb 15.Custom-made orthesis and shoes in a structured follow-up program reduces the incidence of neuropathic ulcers in high-risk diabetic foot patients.Rizzo L1, Tedeschi A, Fallani E, Coppelli A, Vallini V, Iacopi E, Piaggesi A.http://www.ncbi.nlm.nih.gov/pubmed/22336901?dopt=Abstract

The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine

February 2016Volume

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http://www.jvascsurg.org/issue/S0741-5214(15)X0005-X

http://www.ncbi.nlm.nih.gov/pubmed/22336901?dopt=Abstract



63, Issue 2, Supplement, Pages 3S–21S

http://www.jvascsurg.org/article/S0741-5214(15)02025-X/abstract

Older AdultsAnnual screening for cognitive impairment is indicated for adults age 65 years or older for early detection of mild cognitive impairment or dementia B

New from psychosocial position statement

This is a more specific version of a recommendation we already have—annual may be a bit much. Need to check against references—is annual really necessary?

Persons who screen positive for cognitive impairments should receive diagnostic assessment as appropriate including referral to a behavioral health provider for formal cognitive/neuropsychological evaluation. B


Move to text

Older adults with diabetes should be assessed for disease treatment and self-management knowledge, health literacy and numeracy at the onset of treatment. Self-management knowledge and skills should be re-assessed when regimen changes are made or an individual’s functional abilities diminish.E


Shift to text

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Declining or impaired ability to perform diabetes self-care behaviors may be an indication for referral of older adults with diabetes for cognitive and physical functional screening using age normed evaluation tools. E


Shift to text

Social and instrumental support networks (e.g. adult children, caretakers) who provide instrumental or emotional support for older adults with diabetes should be included in diabetes management discussions and shared decision-making.E


Shift to text

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

Citation #3 (Chapter 10)


Screening for geriatric syndromes may be appropriate in older adults experiencing limitations in their basic and instrumental activities of daily living, as they may affect diabetes self-management. E

Additional relevant evidence



Laiteerapong N, Karter AJ, Liu JY, et al. Correlates of quality of life in older adults with diabetes: the Diabetes & Aging Study. Diabetes

Care 2011;34:1749–1753

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

Citation # 2 (Chapter 10)


Hypoglycemia should be avoided in older adults with diabetes. It should be screened for and managed by adjusting glycemic targets and pharmacological interventions. B



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

Additional relevant reference



Blaum C, Cigolle CT, Boyd C, et al.Clinical complexity in middle-aged and older adults with diabetes: the Health and Retirement Study.Med Care 2010; 48:327–334http://www.ncbi.nlm.nih.gov/pubmed/20355264

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. E


Citation #3 (Chapter 10)http://www.ncbi.nlm.nih.gov/pubmed/23100048

Blaum C, Cigolle CT, Boyd C, et al.Clinical complexity in middle-aged and older adults with diabetes: the Health and Retirement Study.Med Care 2010; 48:327–334

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Screening for diabetes complications should be individualized in older adults, but particular attention should be paid to complications that would lead to functional impairment. E



Other cardiovascular risk factors should be treated in older adults with consideration of the time frame of benefit and the individual patient. Treatment of hypertension is indicated in virtually all older adults, and lipid-lowering and aspirin therapy may benefit those with life expectancy at least equal to the time frame of primary or secondary prevention trials. E



Blaum C, Cigolle CT, Boyd C, et al.Clinical complexity in middle-aged and older adults with diabetes: the Health and Retirement Study.Med Care 2010; 48:327–334http://www.ncbi.nlm.nih.gov/pubmed/20355264

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 withdrawal of lipid-lowering therapy may be appropriate. E

Updating reference Munshi M, Florez H, Huang ES et al. Management of Diabetes in Long-term Care and Skilled Nursing Facilities: A Position Statement of the American Diabetes Association. Diabetes Care. 2016;39(2):308-18http://www.ncbi.nlm.nih.gov/pubmed/26798150

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Consider diabetes education for the staff of long-term care facilities to improve the management of older adults with diabetes. E


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


Children and AdolescentsProviders should monitor youth and their

New from psychosocial statement

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parents about social adjustment (peer relationships) and school performance to determine whether further evaluation is needed. B,EYouth with diabetes should be clinically assessed for generic and diabetes-related distress as early as development indicates, generally at 7-8 years of age. More detailed questioning should begin by the age at which children can provide assent to receiving care, usually age 12. Practitioners should include children in consenting processes as early as cognitive development indicates understanding of health consequences of behavior.A,E

New from psychosocial statementAlicia:

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


Why 12?

Providers should begin to discuss care transition to an adolescent medicine/transition clinic/adult provider no later than one year prior to starting the transfer, but preferably during early adolescence (~ age 14). E


Support from

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parents/caretakers should be monitored in emerging adults with diabetes. Instrumental support (e.g., ordering supplies) and optimizing collaborative decision making among caregivers should be encouraged. A, EYouth and families who are demonstrating difficulty with self-care behaviors, repeated hospitalizations for DKA or significant distress should be referred to a behavioral health provider for assessment and treatment.E


Girls who have reached childbearing age should be given preconception counseling as part of routine management. AMales at the time of puberty should be counseled regarding adoption of a healthy lifestyle to reduce risk for sexual dysfunction. EYouth 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



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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 experi enced in childhood diabetes. E

Additional evidence: Pediatric Diabetes Consortium T1D and T2D registries: Symptoms of depression were identified in 13% of T1D and 22% of T2D participantsAdd comment: “Depressive symptoms are more frequent than diagnosed depression in youth with T1D or T2D and underscore the need for regular depression screening and appropriate referral for youth with diabetes.”








Silverstein J, Cheng P, Ruedy KJDepressive Symptoms in Youth With Type 1 or Type 2 Diabetes: Results of the Pediatric Diabetes Consortium Screening Assessment of Depression in Diabetes Study. Diabetes Care. 2015; 38(12):2341-3.http://www.ncbi.nlm.nih.gov/pubmed/26459274

Encourage developmentally appropriate family involvement in diabetes management tasks for children and adolescents,

N/A Citation #15 (Chapter 11)http://www.ncbi.nlm.nih.gov/pubmed/22361221

Citation #16 (Chapter

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recognizing that premature transfer of diabetes care to the child can result in nonadherence and deterioration in glycemic control. B

11)http://www.ncbi.nlm.nih.gov/pubmed/20032278


Consider mental health professionals as integral members of the pediatric diabetes multidisciplinary team. E

N/A Citation #14 (Chapter 11)http://www.ncbi.nlm.nih.gov/pubmed/12147143

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

Citation #20Blasetti: Meta-analysis confirms that recurrent severe hypoglycemia has a selective negative effect on the children's cognitive functions. Caution with small sample sizes, the different definitions of severe hypoglycemia, and variety of neuropsychological tests used.

Data from T1D Exchange:Children with excellent glycemic control tend to exhibit markedly different diabetes self-management techniques than those with poor control.

Old Citation #18 (Chapter 11)Diabetes Care. 2013 May;36(5):1384-95. doi: 10.2337/dc12-2480. Epub 2013 Apr 15. Omit this citation.

Citation # 19 (Chapter 11)http://www.ncbi.nlm.nih.gov/pubmed/12663580?dopt=Citation

Citation # 21 (Chapter 11)http://www.ncbi.nlm.nih.gov/pubmed/23832082



New Citation #18? (Chapter 11)Campbell MS, Schatz DA, Chen V, et al. A contrast between children and adolescents with excellent and poor control: the T1D Exchange clinic registry experience. Pediatr Diabetes. 2014; 15(2):110-7. doi: 10.1111/pedi.12067.http://www.ncbi.nlm.nih.gov/pubmed/23957219

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http://www.ncbi.nlm.nih.gov/pubmed/12663580?dopt=Citation














Citation #24 (Chapter 11)http://www.ncbi.nlm.nih.gov/pubmed/16740856?dopt=Citation





Assess for the presence of additional autoimmune conditions soon after the diagnosis and if symptoms develop. E

Where should these green highlighted recs go? They are not limited to children but should be expanded to include any person with type 1 diabetes (child or adult)

For now, we have duplicated this first rec into the new comprehensive medical


Citation #29 (Chapter 11)http://www.ncbi.nlm.n

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management section ih.gov/pubmed/21430083




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

See above

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

See above

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Consider screening children individuals 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

Additional reference - proposal to upgrade recommendation to C. Meta-analysis/ systematic review of studies with at least 100 individuals with type 1 diabetes screened for coeliac disease: More than one in twenty patients with type 1 diabetes have biopsy-verified coeliac disease.







Elfström P1, Sundström J, Ludvigsson JF. Systematic review with meta-analysis: associations between coeliac disease and type 1 diabetes.Aliment Pharmacol Ther. 2014 Nov;40(10):1123-32.http://www.ncbi.nlm.nih.gov/pubmed/25270960

Consider screening in individualschildren 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

See above—should this be “individuals” still

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children with frequent unexplained hypoglycemia or deterioration in glycemic control. EChildren Individuals with biopsy-confirmed 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

See above

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 blood pressure confirmed on 3 separate days. B

Citation # 39 (Chapter 11)http://www.ncbi.nlm.nih.gov/pubmed/25114297

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

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lifestyle intervention, pharmacological treatment should be considered. EIn 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. EACE inhibitors or angiotensin recep tor blockers should be considered forthe initial pharmacological treatment of hypertension, following reproductive counseling due to the potential teratogenic effects of both drug classes. EThe goal of treatment is blood pressure consistently <90th percentile for age, sex, and height. EObtain a fasting lipid profile in children 10 years of age soon after the diagnosis (after glucose control has been established). E



Citation #42 (Chapter 11

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)http://www.ncbi.nlm.nih.gov/pubmed/16443863




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

Check with alignment with nutrition section-adults

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




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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. E



The goal of therapy is an LDL cholesterol value <100 mg/dL (2.6 mmol/L). EElicit a smoking history at initial and follow-up


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diabetes visits and discourage smoking in youth who do not smoke and encourage smoking cessation in those who do smoke. B


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


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


Treatment with an ACE inhibitor, titrated to normalization of albumin excretion, should be considered when elevated urinary albumin–to–creatinine ratio (>30 mg/g) is documented with at least two of three urine samples. These should be obtained over a 6-month interval following efforts to improve glycemic control and normalize blood pressure. B C

Only small studies (no RCT).Consider changing recommendation to C (or E)


.

An initial dilated and comprehensive eye examination is recommended at age 10 years or after puberty has started, whichever is earlier, once the youth has had diabetes for 3–5 years.


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BAfter 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. EConsider 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


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

Blend this with earlier psychosocial statement




Citation # 73(Chapter 11)http://www.ncbi.nlm.nih.gov/pubmed/11522695?dopt=Citation

Citation # (Chapter 11)http://www.ncbi.nlm.nih.gov/

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pubmed/15983310?dopt=Citation

Both pediatricians and adult health care providers should assist in providing support and links to resources for the teen and emerging adult. BManagement of Diabetes in PregnancyProvide preconception counseling that addresses 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

N/A Citations #3, 4, 5, 6, 10 (Chapter 12)






Family planning should be discussed and effective contraception should be prescribed and used until a woman is prepared and ready to become pregnant. AWomen with preexisting type 1 or type 2 diabetes who are planning pregnancy or who have become


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pregnant should be counseled on the risk of development and/or progression of diabetic retinopathy. Dilated eEye examinations should occur before pregnancy or in the first trimester and then be monitored every trimester and for 1 year postpartum as indicated by degree of retinopathy. 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

Two RCTs that are not new, but provide the evidence that lifestyle changes suffice to treat GDM in the majority of cases.



Crowther CA, et al. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. NEJM 2005;352:2477-86http://www.ncbi.nlm.nih.gov/pubmed/15951574Landon MB, Spong CY, Thom E et al. A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. NEJM 361:1339-48, 2009http://www.ncbi.nlm.nih.gov/pubmed/19797280

Insulin is the preferred medication for treating hyperglycemia in gestational diabetes 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 to a greater extent than glyburide. Glyburide

Clarify that insulin is treatment of choice.

This proposed modification is based onConcentration of metformin on the fetal side of the placenta to levels similar to or twice those in the maternal circulation.

Glyburide levels in cord blood have been shown



Since this systematic review suggested that metformin has a more favorable short term outcome profile than glibenclamide, but metformin appears to

Vanky E, Zahlsen K, Spigset O, Carlsen SM: Placental passage of metformin in women with polycystic ovary syndrome. Fertility Sterility 2005;83:1575-1578http://www.ncbi.nlm.nih.gov/pubmed/15866611

Charles B, Norris R, Xiao X, Hague W. Population

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may have a higher rate of neonatal hypoglycemia and macrosomia than insulin or metformin. Other agents have not been adequately studied. All oral agents lack long-term safety data. APreferred medications in gestational diabetes mellitus are insulin and metformin; glyburide may be used but may have a higher rate of neonatal hypoglycemia and macrosomia than insulin or metformin. Other agents have not been adequately studied. Most oral agents cross the placenta, and all lack long-term safety data. A

to be approximately 70% of simultaneous maternal level.

Condense, add some to text, add treatment failures to text (half of metformin treated end up on insulin)

Check on FDA category for insulin change

be concentrated on the fetal side of the placenta, it may be better (prudent) to be non-directive about the choice between the two when patients decline to take insulin injections.

pharmacokinetics of metformin in late pregnancy. Ther Drug Monit 2006; 28: 67-72.http://www.ncbi.nlm.nih.gov/pubmed/16418696

Hebert MF et al: Are we optimizing gestational diabetes treatment with glyburide? Clinical Pharmacology & Therapeutics 85:607-614, 2009http://www.ncbi.nlm.nih.gov/pubmed/19295505

Potentially teratogenic medications (ACE inhibitors, statins, etc.) should be avoided in sexually active women of childbearing age who are not using reliable contraception. B

Citations about statin, ACE-inhibitors and ARBs use in pregnancy

Taguchi N, Rubin ET, Hosokawa A, Choi J, Ying AY, Moretti ME, et al. Prenatal exposure to HMG-CoA reductase inhibitors: effects on fetal and neonatal outcomes. Reprod Toxicol 2008;26:175–7.http://www.ncbi.nlm.nih.gov/pubmed/18640262

Bateman BT, Hernandez-Diaz S, Fischer MA et al. Statins and congenital malformations: cohort study. BMJ. 2015 Mar 17;350:h1035http://www.ncbi.nlm.nih.gov/pubmed/25784688

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Zarek J, Koren G. The fetal safety of statins: a systematic review and meta-analysis. J Obstet Gynaecol Can. 2014; 36(6):506-9.http://www.ncbi.nlm.nih.gov/pubmed/24927189

Bullo M1, Tschumi S, Bucher BS, et al. Pregnancy outcome following exposure to angiotensin-converting enzyme inhibitors or angiotensin receptor antagonists: a systematic review. Hypertension. 2012; 60(2): 444-50. PMID: 22753220http://www.ncbi.nlm.nih.gov/pubmed/22753220

Fasting, preprandial, and postprandial self-monitoring of blood glucose are recommended in both gestational diabetes mellitus and preexisting type 2 diabetes not on multiple daily injections. In addition, preprandial monitoring of blood glucose is also recommended for pregestational preexisting type 1 diabetes and for those on multiple daily injections in pregnancy to achieve glycemic control. B

While preprandial glucose monitoring is standard in nonpregnant individuals with type 1 or type 2 diabetes, available data do not support its use in pregnancy (with regard to improving pregnancy outcomes) and most caregivers involved in the field do not ask their patients to monitor blood sugars preprandially. This would be even more true with gestational diabetes.

Say preprandial is fine in text—necessary for

RCT of preprandial vs postprandial glucose testing in GDM:

De Veciana M, Major CA, Morgan MA et al. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. NEJM 1995; 333: 1237-41.http://www.ncbi.nlm.nih.gov/pubmed/7565999

Ancillary analysis from DIEP observational study showing that

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carb counting postprandial glucose values are more predictive of fetal macrosomia than fasting values:

Jovanovic-Peterson L, Peterson CM, Reed GF, et al. Maternal postprandial glucose levels and infant birth weight: the Diabetes in Early Pregnancy Study. The National Institute of Child Health and Human Development--Diabetes in Early Pregnancy Study. Am J Obstet Gynecol. 1991; 164:103-11. PMID: 1986596http://www.ncbi.nlm.nih.gov/pubmed/1986596

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 achieved without significant hypoglycemia, but the target may be relaxed to <7% (53 mmol/mol) if necessary to prevent hypoglycemia. B

N/A

There is an additional reference with a larger sample size (445 non diabetic pregnant women) who were tested at between 15 and 36 weeks and compared to 384 non-pregnant controls. It provides standards for various gestational intervals.

Citations #3, #4 #12 (Chapter 12)http://www.ncbi.nlm.nih.gov/pubmed/17446531



Citation #12 is a study of 100 pregnant women without diabetes and supports the assertion that A1c is lower in early and later pregnancy than in the non-pregnant state.

Mosca A, Paleari R, Dalfra MG, DiCianni G et al. Reference intervals for hemoglobin A1c in pregnant women: data from an Italian multicenter study. Clinical Chemistry 2006; 52(6): 1138-1143.http://www.ncbi.nlm.nih.gov/pubmed/16601066

Diabetes Care in the Hospital

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Consider performing an A1C on all patients with diabetes or hyperglycemia admitted to the hospital if not performed in the prior 3 months. C

New evidence that supports use of A1C

But still a C recommendation

Pasquel FJ, Gomez-Huelgas R, Anzola L et al. Predictive Value of Admission Hemoglobin A1c on Inpatient Glycemic Control and Response to Insulin Therapy in Medicine and Surgery Patients With Type 2 Diabetes. Diabetes Care 2015 Dec; 38(12): e202-e203http://www.ncbi.nlm.nih.gov/pubmed/26519335Umpierrez GE, Reyes D, Smiley D, et al. Hospital Discharge AlgorithmBased on Admission HbA1c for the Management of Patients With Type 2 Diabetes. Diabetes Care. 2014; 37: 2934-9http://www.ncbi.nlm.nih.gov/pubmed/25168125

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 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

N/A

(removing non critical ill patients C)


More stringent goals, such as 110–140 mg/dL (6.1–7.8 mmol/L) may be appropriate for selected critically ill


http://

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patients, as long as this can be achieved without significant hypoglycemia. C

www.ncbi.nlm.nih.gov/pubmed/19429873

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



Consensus of two advisors is that this prior consensus was best in absence of data.Change letter to Eundo


Umpierrez GE, Hellman R, Korytkowski MT, et al. Management of Hyperglycemia in HospitalizedPatients in Non-Critical Care Setting: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 97: 16–38, 2012http://www.ncbi.nlm.nih.gov/pubmed/22223765

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

Citations # 10, 13 ( Chapter 13)



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

Citations #2, 11 (Chapter 13)



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 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

Change this to <50 or 55 depending on where hypoglycemia position statement ends up


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

Add more details about avoiding readmissions


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