7. Diabetes Technology: StandardsofMedicalCare inDiabetesd2020Diabetes Care 2020;43(Suppl. 1):S77–S88 | https://doi.org/10.2337/dc20-S007

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”includes the ADA’s current clinical practice recommendations and is intended toprovide the components of diabetes care, general treatment goals and guidelines,and tools to evaluate quality of care. Members of the ADA Professional PracticeCommittee, amultidisciplinary expert committee (https://doi.org/10.2337/dc20-SPPC),are responsible for updating the Standards of Care annually, or more frequently aswarranted. For a detailed description of ADA standards, statements, and reports, aswellas theevidence-gradingsystemforADA’sclinicalpracticerecommendations,pleasereferto theStandardsofCare Introduction (https://doi.org/10.2337/dc20-SINT). Readerswhowish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

Diabetes technology is the termused to describe the hardware, devices, and softwarethat people with diabetes use to help manage their condition, from lifestyle to bloodglucose levels. Historically, diabetes technology has been divided into two maincategories: insulin administered by syringe, pen, or pump, and blood glucosemonitoring as assessed by meter or continuous glucose monitor. More recently,diabetes technology has expanded to include hybrid devices that both monitorglucose and deliver insulin, some automatically, as well as software that serves as amedical device, providing diabetes self-management support. Diabetes technology,when coupled with education and follow-up, can improve the lives and health ofpeople with diabetes; however, the complexity and rapid change of the diabetestechnology landscape can also be a barrier to patient and provider implementation.

OVERALL STATEMENT

Recommendation

7.1 Use of technology should be individualized based on a patient’s needs,desires, skill level, andavailabilityofdevices.Nonprofitwebsitescanofferadvicefor providers and patients to determine the suitability of various options. E

Technology is rapidlychanging,but there isno“one-size-fits-all”approachtotechnologyuse in people with diabetes. Insurance coverage can lag behind device availability,patient interest in devices and willingness to change can vary, and providers may havetrouble keeping up with newly released technology. Not-for-profit websites such asDiabetesWise.org (1) and others can help providers and patients make decisions asto the initial choice of devices. Other sources, including health care providers anddevice manufacturers, can help people troubleshoot when difficulties arise.

SELF-MONITORING OF BLOOD GLUCOSE

Recommendations

7.2 Most patients using intensive insulin regimens (multiple daily injections orinsulin pump therapy) should be encouraged to assess glucose levels using

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© 2019 by the American Diabetes Association.Readersmayuse this article as longas thework isproperly cited, the use is educational and notfor profit, and the work is not altered. More infor-mation is available at http://www.diabetesjournals.org/content/license.

American Diabetes Association

Diabetes Care Volume 43, Supplement 1, January 2020 S77

7.DIABETES

TECHNOLO

GY

This article includes updates in the form of annotations as of June 2020. See page S83.

self-monitoring of blood glucose(and/or continuous glucosemon-itoring) prior to meals andsnacks, at bedtime, prior to ex-ercise, when they suspect lowblood glucose, after treatinglow blood glucose until theyare normoglycemic, and priorto and while performing criticaltasks such as driving. B

7.3 When prescribed as part of adiabetes self-management edu-cation and support program, self-monitoring of blood glucose mayhelp to guide treatmentdecisionsand/or self-management for pa-tients taking less-frequent insulininjections. B

7.4 Although self-monitoring of bloodglucose in patients on noninsulintherapies has not shown clinicallysignificant reductions in A1C, itmay be helpful when alteringdiet, physical activity, and/ormedications (particularly medica-tions that can cause hypoglyce-mia) inconjunctionwithatreatmentadjustment program. E

7.5 When prescribing self-monitoringof blood glucose, ensure that pa-tients receive ongoing instructionand regular evaluation of techni-que, results, and their ability to usedata from self-monitoring of bloodglucose to adjust therapy. E

7.6 Health care providers should beaware of medications and otherfactors, such as high-dose vita-min C and hypoxemia, that caninterfere with glucose meteraccuracy and provide clinicalmanagement as indicated. E

7.7 Providers should be aware of thedifferences in accuracy amongglucose metersdonly U.S. Foodand Drug Administration–approvedmeters should be used with un-expired strips, purchased from apharmacy or licensed distributor. E

Major clinical trials of insulin-treatedpatients have included self-monitoringof blood glucose (SMBG) as part ofmultifactorial interventions to demon-strate the benefit of intensive glycemiccontrol on diabetes complications (2).SMBG is thus an integral componentof effective therapy of patients tak-ing insulin. In recent years, continuous

glucose monitoring (CGM) has emergedas a method for the assessment of glu-cose levels (discussed below). Glucosemonitoring allows patients to evaluatetheir individual response to therapy andassess whether glycemic targets arebeing safely achieved. Integratingresults into diabetes management canbe a useful tool for guiding medicalnutrition therapy and physical activity,preventing hypoglycemia, and adjustingmedications (particularly prandial insulindoses). The patient’s specific needs andgoals should dictate SMBG frequencyand timing or the consideration ofCGM use.

Optimizing SMBG Monitor UseSMBG accuracy is dependent on theinstrument and user, so it is importantto evaluate each patient’s monitoringtechnique, both initially and at regularintervals thereafter. Optimal use ofSMBG requires proper review and in-terpretation of the data, by both thepatient and the provider, to ensure thatdata are used in an effective and timelymanner. In patients with type 1 diabetes,there is a correlation between greaterSMBG frequency and lower A1C (3).Among patients who check their bloodglucose at least once daily, many reporttaking no action when results are high orlow (4). Patients should be taught howto use SMBG data to adjust foodintake, exercise, or pharmacologic ther-apy to achieve specific goals. The ongoingneed for and frequency of SMBG shouldbe reevaluated at each routine visit toavoid overuse, particularly if SMBG is notbeing used effectively for self-management(4–6).

Patients on Intensive Insulin Regimens

SMBG is especially important for insulin-treated patients to monitor for and pre-vent hypoglycemia and hyperglycemia.Most patients using intensive insulin regi-mens (multiple daily injections or insulinpump therapy) should be encouraged toassess glucose levels using SMBG (and/or CGM) prior to meals and snacks, atbedtime, occasionally postprandially,prior to exercise, when they suspect lowblood glucose, after treating low bloodglucose until they are normoglycemic,and prior to andwhile performing criticaltasks such as driving. For many patientsusing SMBG, this will require testing upto 6–10 times daily, although individualneeds may vary. A database study of

almost 27,000 children and adolescentswith type 1 diabetes showed that, afteradjustment for multiple confounders,increased daily frequency of SMBGwassignificantly associated with lower A1C(–0.2% per additional test per day) andwith fewer acute complications (7).

Patients Using Basal Insulin and/or

Oral Agents

The evidence is insufficient regardingwhen to prescribe SMBG and how oftentesting is needed for insulin-treated pa-tients who do not use intensive insulinregimens, such as those with type 2diabetes using basal insulin with or with-out oral agents. However, for patientsusing basal insulin, assessing fasting glu-cose with SMBG to inform dose adjust-ments to achieve blood glucose targetsresults in lower A1C (8,9).

In people with type 2 diabetes notusing insulin, routine glucose monitoringmay be of limited additional clinicalbenefit. By itself, even when combinedwith education, it has showed limitedimprovement inoutcomes (10–13).How-ever, for some individuals, glucose mon-itoring can provide insight into theimpact of diet, physical activity, andmedication management on glucose lev-els. Glucose monitoring may also beuseful in assessing hypoglycemia, glu-cose levels during intercurrent illness,or discrepancies between measuredA1C and glucose levels when there is con-cern an A1C result may not be reliablein specific individuals. It may be usefulwhen coupled with a treatment adjust-ment program. In a year-long study ofinsulin-naive patients with suboptimalinitial glycemic stability, a group trainedin structured SMBG (a paper tool wasused at least quarterly to collect andinterpret seven-point SMBG profilestaken on 3 consecutive days) reducedtheir A1C by 0.3% more than the controlgroup (14). A trial of once-daily SMBGthat included enhanced patientfeedback through messaging found noclinically or statistically significantchange in A1C at 1 year (13). Meta-analyses have suggested that SMBG canreduce A1C by 0.25–0.3% at 6 months(15–17), but the effect was attenuated at12 months in one analysis (15). Reduc-tions in A1C were greater (20.3%) intrials where structured SMBG data wereused to adjust medications, but A1C wasnot changed significantly without such

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structured diabetes therapy adjustment(17).Akeyconsideration is thatperformingSMBG alone does not lower blood glucoselevels. To be useful, the information mustbe integrated into clinical and self-man-agement plans.

Glucose Meter Accuracy

Although many meters function wellunder a variety of circumstances, pro-viders and people with diabetes need tobe aware of factors that can impair meteraccuracy. A meter reading that seemsdiscordant with clinical reality needs tobe retested or tested in a laboratory.Providers in intensive care unit settingsneed to be particularly aware of thepotential for abnormal meter readings,and laboratory-based values should beused if there is any doubt. Some metersgive error messages if meter readingsare likely to be false (18).Oxygen. Currently available glucose mon-itors utilize an enzymatic reaction linked toanelectrochemical reaction, either glucoseoxidase or glucose dehydrogenase (19).Glucose oxidase monitors are sensitiveto the oxygen available and should onlybe used with capillary blood in patientswith normal oxygen saturation. Higheroxygen tensions (i.e., arterial blood oroxygen therapy) may result in false lowglucose readings, and low oxygen tensions(i.e.,highaltitude,hypoxia,orvenousbloodreadings) may lead to false high glucosereadings. Glucose dehydrogenase moni-tors are not sensitive to oxygen.Temperature.Because the reaction is sen-sitive to temperature, all monitors havean acceptable temperature range (19).Most will show an error if the temper-ature is unacceptable, but a few willprovide a reading and a message indi-cating that the value may be incorrect.Interfering Substances. There are a fewphysiologic and pharmacologic factorsthat interfere with glucose readings.Most interfere only with glucose oxidasesystems (19). They are listed in Table 7.1.

Meter Standards

Glucose meters meeting U.S. Food andDrug Administration (FDA) guidance formeter accuracy provide the most reliabledata for diabetesmanagement. There areseveral current standards for accuracy ofblood glucosemonitors, but the twomostused are those of the International Or-ganization for Standardization (ISO) (ISO15197:2013) and the FDA. The currentISO and FDA standards are compared inTable 7.2. In Europe, currentlymarketedmonitors must meet current ISO stand-ards. In the U.S., currently marketedmonitorsmustmeet the standard underwhich they were approved, which maynot be the current standard. Moreover,the monitoring of current accuracy isleft to the manufacturer and not rou-tinely checked by an independentsource.

Patients assume their glucose monitoris accurate because it is FDA cleared, butoften that is not the case. There is sub-stantial variation in the accuracy ofwidely used blood glucose monitoringsystems (20). The Diabetes TechnologySociety Blood Glucose Monitoring Sys-tem Surveillance Program provides in-formation on the performance of devicesused for SMBG (diabetestechnology.org/surveillance). In a recent analysis, theprogram found that only 6 of the top18 glucose meters met the accuracystandard (21).Counterfeit Strips. Patients should be ad-vised against purchasing or reselling pre-owned or second-hand test strips, asthese may give incorrect results. Onlyunopened vials of glucose test stripsshould be used to ensure SMBG accuracy.

CONTINUOUS GLUCOSEMONITORING DEVICES

See Table 7.3 for definitions of types ofCGM devices.

Recommendations

7.8 Whenprescribing continuous glu-cose monitoring (CGM) devices,robust diabetes education, train-ing, and support are required foroptimal CGM device implementa-tion and ongoing use. Peopleusing CGM devices need tohave the ability to perform self-monitoring of blood glucose inorder to calibrate their monitorand/or verify readings if discor-dant from their symptoms. E

7.9 When used properly, real-timecontinuous glucose monitors inconjunctionwith insulin therapyare a useful tool to lower A1Clevels and/or reduce hypoglyce-mia in adults with type 1 diabeteswho are not meeting glycemictargets, have hypoglycemia un-awareness, and/or have episodesof hypoglycemia. A

7.10 When used properly, intermit-tently scanned continuous glucosemonitors in conjunction with in-sulin therapy are useful tools tolower A1C levels and/or reducehypoglycemia in adults with type1 diabetes who are not meetingglycemic targets, have hypogly-cemia unawareness, and/or haveepisodes of hypoglycemia. C

7.11 When used properly, real-timeand intermittently scanned con-tinuous glucose monitors in con-junction with insulin therapy areuseful tools to lower A1C and/orreduce hypoglycemia in adultswith type 2 diabetes who arenot meeting glycemic targets. B

7.12 Continuous glucose monitoring(CGM) should be considered in allchildren andadolescentswith type1 diabetes, whether using injec-tions or continuous subcutaneousinsulin infusion, as an additionaltool to help improve glucose con-trol. Benefits of CGM correlatewith adherence to ongoing useof the device. B

7.13 Real-time continuous glucosemonitoring (CGM) devices shouldbe used as close to daily as pos-sible for maximal benefit. Inter-mittently scanned CGM devicesshould be scanned frequently, ata minimum once every 8 h. A

7.14 Real-time continuous glucose mon-itors may be used effectively toimprove A1C levels, time in range,andneonataloutcomesinpregnantwomen with type 1 diabetes. B

7.15 Blinded continuous glucosemonitor data, when coupledwith diabetes self-managementeducation and medication doseadjustment, can be helpful inidentifying and correcting pat-terns of hyper- and hypoglyce-mia in people with type 1diabetes and type 2 diabetes. E

Table 7.1—Interfering substances forglucose readingsGlucose oxidase monitorsUric acidGalactoseXyloseAcetaminophenL-dopaAscorbic acid

Glucose dehydrogenase monitorsIcodextrin (used in peritoneal dialysis)

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7.16 People who have been usingcontinuous glucose monitorsshould have continued accessacross third-party payers. E

CGM measures interstitial glucose(which correlates well with plasma glu-cose). There are two basic types of CGMdevices: those that provide unblinded datato the user and those that are blindedwithdata available to the patient and theirhealth care provider for retrospective anal-ysis. Table 7.3 provides the definitionsfor the types of CGM devices. For devicesthat provide patients unblinded data,most of the published randomized con-trolled trials (RCTs) have been performedusing real-time CGM devices that havealarms and alerts. It is difficult to deter-mine how much impact having thesenotices makes in terms of reacting toglucose levels. There is one small studyin patients at risk for hypoglycemia thatcompares real-time CGM with intermit-tently scanned CGM (isCGM) (22). Thestudy showed improvement in time spentin hypoglycemiawith real-timeCGMcom-pared with isCGM.

Some real-time systems require calibra-tion by the user, which varies in frequencydepending on the device. Additionally, forsome CGM systems, the FDA suggestsSMBG for making treatment decisions.Devices that require SMBG confirmationare called “adjunctive,” while those thatdo not are called “nonadjunctive.” An RCTof 226 adults suggested that aCGMdevicecould be used safely and effectively with-out regular confirmatory SMBG in patientswith well-controlled type 1 diabetes atlow risk of severe hypoglycemia (23). TwoCGM devices are approved by the FDAfor making treatment decisions withoutSMBG calibration or confirmation (24,25).

The abundance of data provided byCGM offers opportunities to analyze pa-tient data more granularly than was pre-viously possible, providing additionalinformation to aid in achieving glycemictargets. A variety of metrics have been pro-posed (26) and are discussed in Section6, “Glycemic Targets” (https://doi.org/10.21337/dc20-S006). CGM is essential forcreating the ambulatory glucose profile(AGP) and providing data on time inrange, percentage of time spent aboveand below range, and variability (27).

Real-time CGM Device Use in AdultsWith Type 1 DiabetesData exist to support the use of real-timeCGM in adults, both those on multipledaily injections (MDI) and continuoussubcutaneons insulin infusion (CSII). Interms of RCTs in people with type 1diabetes, there are four studies in adultswith A1C as the primary outcome(28–32), three studies in adults withhypoglycemia as the primary outcome(33–35), four studies in adults and chil-dren with A1C as the primary outcome(36–39), and three studies in adults andchildren with hypoglycemia as a primaryoutcome (40–42).

Primary Outcome: A1C Reduction

In general, A1C reduction was shown instudies where the baseline A1C was higher.In two larger studies in adults with type 1diabetes that assessed the benefit of real-time CGM in patients on MDI, there weresignificant reductions in A1C: –0.6% in one(28,29) and –0.43% in the other (30). Noreduction inA1Cwasseen inasmall studyperformed in underserved, less well-educated adults with type 1 diabetes(31). In the adult subset of the JDRF CGMstudy, there was a significant reduction inA1C of –0.53% (43) in patients who wereprimarily treated with insulin pump ther-apy. Better adherence in wearing thereal-time CGM device resulted in agreater likelihood of an improvement inglycemic control (32,36).

Primary Outcome: Hypoglycemia

In studies in adults where reduction inepisodes of hypoglycemia was the pri-mary end point, significant reductionswere seen in individuals with type 1diabetes on MDI or CSII (33–35). Inone study in patients whowere at higherrisk for episodes of hypoglycemia (35),therewas a reduction in rates of all levelsof hypoglycemia (see Section 6 “Glycemic

Table 7.2—Comparison of ISO 15197:2013 and FDA blood glucose meter accuracy standards

Setting FDA (154,155) ISO 15197:2013 (156)

Home use 95% within 15% for all BG in the usable BG range† 95% within 15% for BG $100 mg/dL99% within 20% for all BG in the usable BG range† 95% within 15 mg/dL for BG ,100 mg/dL

Hospital use 95% within 12% for BG $75 mg/dL99% in A or B region of consensus error grid‡

95% within 12 mg/dL for BG ,75 mg/dL98% within 15% for BG $75 mg/dL98% within 15 mg/dL for BG ,75 mg/dL

BG, blood glucose; FDA, U.S. Food and Drug Administration; ISO, International Organization for Standardization. To convert mg/dL to mmol/L, seeendmemo.com/medical/unitconvert/Glucose.php. †The range of blood glucose values for which themeter has been proven accurate andwill providereadings (other than low, high, or error). ‡Values outside of the “clinically acceptable” A and B regions are considered “outlier” readings and may bedangerous to use for therapeutic decisions (157).

Table 7.3—Continuous glucose monitoring (CGM) devices

Real-time CGM CGM systems that measure glucose levels continuously andprovide the user automated alarms and alerts at specificglucose levels and/or for changing glucose levels.

Intermittently scanned CGM CGM systems that measure glucose levels continuously butonly display glucose values when swiped by a reader ora smart phone that reveals the glucose levels.

Blinded (professional) CGM CGM devices that measure glucose levels that are notdisplayed to the patient in real time. These devices aregenerally initiated in a clinic, using a reader that isowned by the clinic. They are removed after a period oftime (generally 10–14 days) and analyzed by the patientand provider to assess glycemic patterns and trends.

Unblinded CGM CGM devices that measure glucose levels that are displayedto the patient.

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Targets,” https://doi.org/10.2337/dc20-S006,for hypoglycemia definitions). Real-timeCGM may be particularly useful in in-sulin-treated patients with hypogly-cemia unawareness and/or frequenthypoglycemic episodes, although studieshave not been powered to show con-sistent reductions in severe (level 3)hypoglycemia (36–38).

Intermittently Scanned CGM DeviceUse in Adults With Type 1 DiabetesisCGMdoes not currently provide alarmsand alerts but is an option used by manypatients. There is relatively little RCTdataproving benefit in people with type 1diabetes. One study, designed to show areduction in episodes of hypoglycemia inpatients at higher risk for hypoglycemia,showed a significant benefit in terms oftime spent in a hypoglycemic range (P,0.0001) (33). Additional observationalstudies have shown benefit in termsof A1C reduction (44).There are several published reviews

of data available on isCGM (45–47). TheNorwegian Institute of Public Health con-ducted an assessment of isCGM clini-cal effectiveness, cost-effectiveness, andsafety for individuals with type 1 andtype 2 diabetes, based on data availableuntil January 2017 (45). The authors con-cluded that, although there were fewquality data available at the time of thereport, isCGM may increase treatmentsatisfaction, increase time in range, andreduce frequency of nocturnal hypoglyce-mia, without differences in A1C or qualityof life or serious adverse events. TheCanadian Agency for Drugs and Technol-ogies in Health reviewed existing data onisCGM performance and accuracy, hypo-glycemia, effect on A1C, and patient sat-isfaction and quality of life and concludedthat the system could replace SMBG,particularly in patients who requirefrequent testing (46). A final review (47)also supported the use of isCGMas amoreaffordable alternative to real-time CGMsystems for individuals with diabetes whoare on intensive insulin therapy.

Real-time and Intermittently ScannedCGM Device Use in Adults With Type 2DiabetesStudies inpeoplewith type2diabetesareheterogeneous in designdin two, par-ticipants were using basal insulin withoral agents or oral agents alone (48,49);in one, individuals were on MDI alone

(50); and in another, participants were onCSII or MDI (42). The findings in studieswithMDI alone (50) and in two studies inpeople using oral agents with or with-out insulin (48,49) showed significantreductions in A1C levels. The MultipleDaily Injections and Continuous GlucoseMonitoring in Diabetes (DIAMOND) studyin people with type 2 diabetes onMDI didnot show a reduction in hypoglycemia(50), although it did show a reduction inA1C. Studies in individuals with type 2diabetes on oral agents with or withoutinsulin did not show reductions in rates ofhypoglycemia (48,49).

In one study of isCGM in people withtype 2 diabetes on a variety of insulinregimens and an initial A1C of;8.8%, noreduction in A1C was seen; however, thetime spent in a hypoglycemic range wasreduced by 43% (51). In a study of isCGMin individuals with type 2 diabetes onMDI, the A1C was reduced by 0.82% inthe intervention group and 0.33% in thecontrol group (P50.005)with no changein rates of hypoglycemia (52).

Real-time CGM Device Use in Childrenand Adolescents With Type 1 DiabetesDataregardinguseofreal-timeCGMinyouthconsist of findings from RCTs and smallobservational studies as well as analysisof data collected by registries. Seven RCTshave included both adult and pediatric par-ticipants (36–42), while others have onlyincludedpediatricparticipants (53)or limitedthe analysis of larger studies to just thepediatric participants (36). Given the feasi-bility problems of performing RCTs in veryyoung children, small observationalstudies have also provided data onreal-time CGM use in the youngestage-groups (54–56). Finally,while limitedby theobservational nature, registry dataprovide some evidence of real-world useof the technologies (43,57).

Impact on Glycemic Control

When data from adult and pediatric par-ticipants are analyzed together, real-timeCGMuse inRCTshasbeenassociatedwithreduction in A1C levels (37–39). Yet in theJDRF CGM trial, when youth were ana-lyzedbyage-group (8- to 14-year-olds and15- to24-year-olds), nochange inA1Cwasseen, likely due to poor real-time CGMadherence (36). Indeed, in a secondaryanalysis of that RCT’s data in bothpediatriccohorts, those who used the sensor $6days/week had an improvement in their

glycemiccontrol(58).Onecriticalcomponentto successwith CGM is near-dailywearing ofthe device (37,59–61).

Though data from small observationalstudies demonstrate that real-time CGMcan be worn by patients,8 years old andthe use of real-time CGM provides insightto glycemic patterns (54,55), an RCT inchildren aged 4–9 years did not demon-strate improvements in glycemic controlfollowing 6months of real-time CGMuse(53). However, observational feasibilitystudies of toddlers demonstrated a highdegree of parental satisfaction and sus-tained use of the devices despite the in-ability to change the degree of glycemiccontrol attained (56).

Registry data has also shown an asso-ciation between real-time CGM use andlower A1C levels (43,57), even when lim-iting assessment of real-time CGM use toparticipants on injection therapy (57).

Impact on Hypoglycemia

There are no studies solely including pedi-atric patients that assess rates of hypogly-cemia as theprimary outcome. Someof thestudies where pediatric and adult patientswerecombinedtogetherdidshowpotentialreductions in hypoglycemia (10,62,63).

Intermittently Scanned CGM DeviceUse in Children and Adolescents WithType 1 DiabetesData on use of isCGM in children come fromobservational studies. In these reports,isCGM is favorably adopted and is associatedwith improvements in outcomes (64–67).

Impact of Frequency of CGM DeviceUse (All Age-groups)For patients with type 1 diabetes usingreal-time CGM, an important predictor ofA1C lowering for all age-groups was fre-quency of sensor use (36). In this study,overall use was highest in those aged$25years(whohadthemost improvementin A1C) and lower in younger age-groups.

Real-time CGM Device Use inPregnancyOne well-designed RCT showed a reduc-tion in A1C levels in adult women withtype 1 diabetes onMDI or CSII who werepregnant (68). Neonatal outcomes werebetter when the mother used CGM dur-ing pregnancy (28). Two studies employ-ing intermittent use of real-time CGMshowed no difference in neonatal out-comes in women with type 1 diabetes(69) or gestational diabetesmellitus (70).

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Use of Blinded (Professional) CGMDevicesBlinded CGM devices, which provideretrospective data for analysis, can beused to identify patterns of hypo- andhyperglycemia. While minimal RCT dataexist to support their use, in some set-tings, blinded CGM can be helpful toevaluate patients when either real-time or isCGM is not available to thepatient or the patient prefers a blindedanalysis. It can be particularly useful toevaluate periods of hypoglycemia inpatients on agents that can cause hy-poglycemia for making medication doseadjustments. It can also be useful toevaluate for periods of hyperglycemia. Useof blinded CGM should always be cou-pled with analysis and interpretation forthe patient, along with education asneeded to adjust medication and changelifestyle behaviors.

Side Effects of CGM DevicesContactdermatitis hasbeen reportedwithall devices that attach to the skin (71). Insome cases this has been linked to thepresence of isobornyl acrylate, which is askin sensitizer and can cause an additionalspreading allergic reaction (72–74). Patchtesting can be done to identify the causeof the contact dermatitis (75).

INSULIN DELIVERY

Insulin Syringes and Pens

Recommendations

7.17 For people with diabetes whorequire insulin, insulin syringesor insulin pens may be used forinsulin deliverywith considerationof patient preference, insulin typeand dosing regimen, cost, andself-management capabilities. B

7.18 Insulin pens or insulin injectionaids may be considered for pa-tients with dexterity issues orvision impairment to facilitatethe administration of accurateinsulin doses. C

7.19 Patients using insulin shouldhave an examination of insulininjection/infusion sites on a rou-tinebasisdat least annually andif there are clinical issues relatedto insulin delivery. E

7.20 Smart pens may be useful forsome patients to help with dosecapture and dosing recommen-dations. E

7.21 U.S. Food and Drug Administration–approvedinsulindosecalculators/decision support systems maybe helpful for titrating insulindoses. E

7.22 Competent patients using dia-betes devices should be allowedto use them in an inpatientsetting when proper supervi-sion is available. E

Injecting insulin with a syringe or pen isthe insulin deliverymethod used bymostpeople with diabetes (76,77), althoughinhaled insulin is also available. Othersuse insulin pumps or automated insulindelivery devices (see sections on thosetopics below). For patients with diabeteswhouse insulin, insulin syringes andpensare both able to deliver insulin safely andeffectively for the achievement of glyce-mic targets. When choosing among de-livery systems, patient preferences, cost,insulin typeanddosing regimen, and self-management capabilities should be con-sidered. It is important to note that whilemany insulin types are available for pur-chase as either pens or vials, others mayonly be available in one formor the otherand there may be significant cost differ-ences between pens and vials (see Table9.3 for a list of insulin product costs withdosage forms). Insulin pens may allowpeople with vision impairment or dex-terity issues to dose insulin accurately(78–80), while insulin injection aids arealso available to help with these issues.(For a helpful list of injection aids, seemain.diabetes.org/dforg/pdfs/2018/2018-cg-injection-aids.pdf.) Inhaled insu-lin can be useful in people who have anaversion to giving injections.

The most common syringe sizes are1 mL, 0.5 mL, and 0.3 mL, allowing dosesof up to 100 units, 50 units, and 30 unitsof U-100 insulin, respectively. In a fewparts of the world, insulin syringes stillhave U-80 and U-40 markings for olderinsulin concentrations and veterinary in-sulin, and U-500 syringes are availablefor the use of U-500 insulin. Syringesare generally used once but may bereused by the same individual in resource-limited settings with appropriate storageand cleansing (81).

Insulin pens offer added convenienceby combining the vial and syringe intoa single device. Insulin pens, allowingpushbutton injections, comeasdisposable

pens with prefilled cartridges or reusableinsulin pens with replaceable insulin car-tridges. Somereusablepens includeamem-ory function,which can recall dose amountsand timing. “Smart” pens that can be pro-grammed to calculate insulin doses andprovide downloadable data reports arealso available. Pens also vary with respectto dosing increment and minimal dose,which can range from half-unit doses to2-unit dose increments.

Needle thickness (gauge) and lengthis another consideration. Needle gaugesrange from 22 to 33, with higher gaugeindicating a thinner needle. A thickerneedle can give a dose of insulin morequickly,while a thinner needlemay causeless pain. Needle length ranges from 4 to12.7mm,with some evidence suggestingshorter needles may lower the risk ofintramuscular injection.Whenreused,nee-dlesmay be duller and thus injectionmorepainful. Proper insulin technique is a req-uisite to obtain the full benefits of insulininjection therapy, and concerns with tech-nique and using the proper technique areoutlined in Section 9 “Pharmacologic Ap-proaches to Glycemic Treatment” (https://doi.org/10.2337/dc20-S009).

Another insulin delivery option is adisposable patch-like device, which pro-vides a continuous, subcutaneous infu-sion of rapid-acting insulin (basal), aswell as 2 unit increments of bolus insulinat the press of a button (82).

Bolus calculators have been developedto aid in dosing decisions (83–87). Theseare subject to FDA approval to ensuresafety in terms of dosing recommenda-tions. People who are interested in usingthese systems should be encouraged touse those that are FDA approved. Pro-vider input and education can be helpfulfor setting the initial dosing calculationswith ongoing follow-up for adjustmentsas needed.

Insulin Pumps

Recommendations

7.23 Insulin pump therapy may beconsidered as an option for alladults, children, and adolescentswith type 1 diabeteswho are ableto safely manage the device. A

7.24 Individuals with diabetes whohave been successfully usingcontinuous subcutaneous insulininfusion should have continuedaccess across third-partypayers.E

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CSII or insulin pumps have been availablein the U.S. for 40 years. These devicesdeliver rapid-acting insulin throughout theday to help manage blood glucose levels.Most insulin pumps use tubing to deliverinsulin through a cannula, while a fewattach directly to the skin, without tubing.Most studies comparing MDI with CSII

have been relatively small and of shortduration. However, a recent systematicreview andmeta-analysis concluded thatpump therapy has modest advantagesfor lowering A1C (20.30% [95%CI20.58to 20.02]) and for reducing severe hypo-glycemia rates in children and adults (88).There is no consensus to guide choosingwhich formof insulin administration is bestfor a given patient, and research to guidethis decision-making is needed (89). Thus,the choice of MDI or an insulin pump isoften based upon the individual character-istics of thepatient andwhich ismost likelyto benefit himor her. Newer systems, suchas sensor-augmented pumps and auto-matic insulin delivery systems, are dis-cussed elsewhere in this section.Adoption of pump therapy in the U.S.

shows geographical variations, whichmay be related to provider preferenceor center characteristics (90,91) and so-cioeconomic status, as pump therapy ismore common in individuals of highersocioeconomic status as reflected byrace/ethnicity, private health insurance,family income, and education (91,92).Given the additional barriers to optimaldiabetes care observed in disadvantagedgroups (93), addressing the differencesin access to insulin pumps and otherdiabetes technology may contribute tofewer health disparities.Pump therapy can be successfully

started at the time of diagnosis (94,95).Practical aspects of pump therapy initia-tion include assessment of patient andfamily readiness (although there is noconsensus on which factors to considerin adults [96] or pediatric patients), se-lection of pump type and initial pumpsettings, patient/family education of po-tential pump complications (e.g., diabeticketoacidosis [DKA] with infusion set fail-ure), transition fromMDI,and introductionof advanced pump settings (e.g., tem-porary basal rates, extended/square/dual wave bolus).Complications of the pump can be

caused by issues with infusion sets (dis-lodgement, occlusion), which place pa-tients at risk for ketosis andDKA and thus

must be recognized and managed early(97); lipohypertrophy or, less frequently,lipoatrophy (98,99); and pump site in-fection (100). Discontinuation of pumptherapy is relatively uncommon today;the frequency has decreased over thepast few decades, and its causes havechanged (100,101). Current reasons forattrition are problems with cost, wear-ability, disliking the pump, suboptimalglycemic control, or mood disorders(e.g., anxiety or depression) (102).

Insulin Pumps in Pediatric PatientsThe safety of insulin pumps in youth hasbeen established for over 15 years (103).Studying the effectiveness of CSII inlowering A1C has been challenging be-cause of the potential selection bias ofobservational studies. Participants onCSII may have a higher socioeconomicstatus that may facilitate better glycemiccontrol (104) versusMDI. In addition, thefast pace of development of new insulinsand technologies quickly renders com-parisons obsolete. However, RCTs com-paring CSII and MDI with insulin analogsdemonstrate a modest improvement inA1C in participants on CSII (105,106).Observational studies, registry data,and meta-analysis have also suggestedan improvement of glycemic control inparticipants on CSII (107–109). Althoughhypoglycemiawas amajor adverse effectof intensified insulin regimen in the Di-abetes Control and Complications Trial(DCCT) (110), data suggest that CSII mayreduce the rates of severe hypoglycemiacompared with MDI (109,111–113).

There is also evidence that CSII mayreduce DKA risk (109,114) and diabetescomplications, in particular, retinopathyand peripheral neuropathy in youth,compared with MDI (62). Finally, treat-ment satisfaction and quality-of-lifemeasures improved on CSII comparedwith MDI (115,116). Therefore, CSII canbe used safely and effectively in youthwith type1diabetes to assistwith achiev-ing targeted glycemic control while re-ducing the risk of hypoglycemia and DKA,improving quality of life and preventinglong-term complications. Based on pa-tient–provider shared decision-making,insulin pumps may be considered in allpediatric patients. In particular, pumptherapy may be the preferred mode ofinsulin delivery for children under 7 yearsof age (63). Because of a paucity of datain adolescents and youth with type 2

diabetes, there is insufficient evidence tomake recommendations.

Commonbarrierstopumptherapyadop-tion in children and adolescents are con-cerns regarding the physical interference ofthe device, discomfort with idea of having adevice on the body, therapeutic effective-ness, and financial burden (107,117).

Insulin Pumps in Patients With Type 2and Other Types of DiabetesCertain patients with insulin deficiency,for instance those with long standingtype 2 diabetes, those who have had apancreatectomy, and/or individuals withcystic fibrosis may benefit from insulinpump therapy. This is an individual de-cision and must be tailored to fit patientneeds and preferences.

Insulin Pumps in Older AdultsOlder individuals with type 1 diabetesbenefit from ongoing insulin pump ther-apy. There is no data to suggest thatmeasurement of C-peptide levels orantibodies predicts success with insulinpump therapy (118,119). Additionally,frequency of follow-up does not influ-ence outcomes. Access to insulin pumptherapy should be allowed/continued inolder adults as it is for younger people.

Combined Insulin Pump and SensorSystems

Recommendations

7.25 Sensor-augmented pump ther-apy with automatic low glucosesuspend may be considered foradults and children with type 1diabetes to prevent/mitigateepisodes of hypoglycemia. B

7.26 Automated insulin delivery systemsmay be considered in children Band adults with type 1 diabetesto improve glycemic control. A

7.27 Individual patientsmay be usingsystems not approved by the U.S.Food and Drug Administrationsuch as do-it-yourself closedloop systems and others; providerscannot prescribe these systemsbut can provide safety informa-tion/troubleshooting/backupadvice for the individual devicesto enhance patient safety. E

Sensor-Augmented PumpsSensor-augmented pumps that suspendinsulin when glucose is low or predicted

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to go low within the next 30 min havebeen approved by the FDA. The Auto-mation to Simulate Pancreatic InsulinResponse (ASPIRE) trial of 247 patientswith type 1 diabetes and documentednocturnal hypoglycemia showed thatsensor-augmented insulin pump therapywith a low glucose suspend functionsignificantly reduced nocturnal hypogly-cemia over 3 months without increasingA1C levels (39). In a different sensor-augmented pump, predictive low glu-cose suspend reduced time spent withglucose,70mg/dL from3.6% at baselineto 2.6% (3.2% with sensor-augmentedpump therapy without predictive lowglucose suspend) without rebound hyper-glycemia during a 6-week randomizedcrossover trial (120). These devices mayoffer the opportunity to reduce hypogly-cemia for thosewith ahistoryofnocturnalhypoglycemia. Additional studies havebeen performed, in adults and children,showing the benefits of this technology(121,122).Automated insulin delivery systems

increase and decrease insulin deliverybased on sensor derived glucose level tobegin to approximate physiologic insulindelivery. These systems consist of threecomponents: an insulin pump, a contin-uous glucose sensor, and an algorithmthat determines insulin delivery. Withthese systems, insulin delivery can notonly be suspended but also increased ordecreased based on sensor glucose val-ues. Emerging evidence suggests suchsystems may lower the risk of exercise-related hypoglycemia (123) and mayhave psychosocial benefits (124–127).While eventually insulin delivery in

closed-loop systems may be truly auto-mated, currently meals must be an-nounced. A so-called hybrid approach,hybrid closed-loop, has been adopted infirst-generation closed-loop systems andrequires users to bolus for meals andsnacks. Multiple studies, utilizing a vari-ety of systems with varying algorithms,pump, and sensors have been performedin adults and children (128–138). Use ofthese systems depends on patient pref-erence and selection of patients (and/orcaregivers) who are capable of safely andeffectively using the devices.Some people with type 1 diabetes

have been using “do-it-yourself” (DIY)systems that combine a pump and a real-time CGM with a controller and analgorithm designed to automate insulin

delivery (139–141). These systems arenot approved by the FDA, although thereare efforts underway to obtain regula-tory approval for them. The informationon how to set up and manage thesesystems is freely available on the inter-net, and there are internet groups wherepeople inform each other as to how to setup and use them. Although not pre-scribed by providers, it is important tokeep patients who are using these meth-ods for automated insulin delivery safe.Part of this entails making sure peoplehave a “backup plan” in case of pumpfailure. Additionally, in most DIY systems,insulin doses are adjusted based on thepump settings for basal rates, carbohy-drate ratios, correction doses, and insulinactivity. Therefore, these settings can beevaluated and changed based on thepatient’s insulin requirements.

Digital Health TechnologyIncreasingly, people are turning to theinternet for advice, coaching, connec-tion, and health care. Diabetes, in partbecause it is both common and numeric,lends itself to the development of appsand online programs. The FDA approvesand monitors clinically validated, digital,usually online, health technologiesintended to treat a medical or psycho-logical conditiondthese are known asdigital therapeutics or “digiceuticals”(142). Other applications, such as thosethat assist in displaying or storing data,encourage a healthy lifestyle or providelimited clinical data support. Therefore, itis possible to find apps that have beenfully reviewed and approved and othersdesigned and promoted by people withrelatively little skill or knowledge in theclinical treatment of diabetes.

Anareaofparticular importance is thatof online privacy and security. There areestablished cloud-based data collectionprograms, such as Tidepool, Glooko, andothers, that have been developed withappropriate data security features andare HIPAA (U.S. Health Insurance Porta-bility and Accountability Act of 1996)compliant. These programs can be usefulfor monitoring patients, both by thepatients themselves as well as theirhealthcareteam(143).Consumersshouldread the policy regarding data privacyand sharing before providing data intoan application and learn how they cancontrol how their datawill be used (someprograms offer the ability to share more

or less information, such as being part ofa registry or data repository or not).

There are many online programs thatoffer lifestyle counseling to aid withweight loss and increase physical activity(144). Many of these include a healthcoach and can create small groups ofsimilar patients in social networks. Thereare programs that aim to treat predia-betes and prevent progression to diabe-tes, often following the model of theDiabetes Prevention Program (145,146).Others assist in improving diabetes out-comes by remotely monitoring patientclinical data (for instance, wireless mon-itoring of glucose levels, weight, or bloodpressure) and providing feedback andcoaching (147–149). There are text mes-saging approaches that tie into a varietyof different types of lifestyle and treat-ment programs, which vary in terms oftheir effectiveness (150,151). Formany ofthese interventions, there are limited RCTdata and long-term follow-up is lacking.But for an individual patient, opting intoone of these programs can behelpful and,for many, is an attractive option.

Inpatient CarePatients who are comfortable using theirdiabetes devices, such as insulin pumpsand sensors, should be given the chanceto use them in an inpatient setting if theyare competent to do so (152,153). Pa-tients who are familiar with treating theirown glucose levels can often adjust in-sulin doses more knowledgably than in-patient staff who do not personally knowthe patient or their management style.However, this should occur based on thehospital’s policies for diabetes manage-ment, and there should be supervision tobe sure that the individual can adjust theirinsulin doses in a hospitalized settingwhere factors such as infection, certainmedications, immobility, changes in diet,and other factors can impact insulin sen-sitivity and the response to insulin.

The FutureThe pace of development in diabetestechnology is extremely rapid. New ap-proaches and tools are available eachyear. It is hard for research to keep upwith these advances because by thetime a study is completed, newer ver-sions of the devices are already on themarket. The most important componentin all of these systems is the patient.Technology selection must be appropriate

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for the individual. Simply having a deviceor application does not change outcomesunless the human being engages with itto create positive health benefits. Thisunderscores the need for the health careprovider to assist the patient in device/program selection and to support its usethrough ongoing education and training.Expectationsmust be temperedby realitydwe do not yet have technology that com-pletely eliminates the self-care tasks neces-sary for treating diabetes, but the toolsdescribed in this section canmake it easierto manage.

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80. Reinauer KM, Joksch G, RennW, EggsteinM.Insulin pens in elderly diabetic patients. DiabetesCare 1990;13:1136–113781. Thomas DR, Fischer RG, NicholasWC, BegheC, Hatten KW, Thomas JN. Disposable insulinsyringe reuse and aseptic practices in diabeticpatients. J Gen Intern Med 1989;4:97–10082. Winter A, Lintner M, Knezevich E. V-Goinsulin delivery system versus multiple dailyinsulin injections for patients with uncontrolledtype 2 diabetes mellitus. J Diabetes Sci Technol2015;9:1111–111683. Bailey TS, Stone JY. A novel pen-based Blue-tooth-enabled insulin delivery system with in-sulin dose tracking and advice. Expert Opin DrugDeliv 2017;14:697–70384. Eiland L, McLarney M, Thangavelu T, DrincicA. App-based insulin calculators: current andfuture state. Curr Diab Rep 2018;18:12385. Huckvale K, Adomaviciute S, Prieto JT, LeowMK-S, Car J. Smartphone apps for calculatinginsulin dose: a systematic assessment. BMCMed2015;13:10686. BretonMD, Patek SD, Lv D, et al. Continuousglucose monitoring and insulin informed advi-sory systemwith automated titration and dosingof insulin reduces glucose variability in type 1diabetes mellitus. Diabetes Technol Ther 2018;20:531–54087. Bergenstal RM, Johnson M, Passi R, et al.Automated insulin dosing guidance to optimiseinsulin management in patients with type 2diabetes: a multicentre, randomised controlledtrial. Lancet 2019;393:1138–114888. Yeh H-C, Brown TT, Maruthur N, et al. Com-parative effectiveness and safety of methodsof insulin delivery and glucose monitoring fordiabetes mellitus: a systematic review and meta-analysis. Ann Intern Med 2012;157:336–34789. Pickup JC. The evidence base for diabetestechnology: appropriate and inappropriatemeta-analysis. J Diabetes Sci Technol 2013;7:1567–157490. Blackman SM, Raghinaru D, Adi S, et al.Insulin pump use in young children in the T1DExchange clinic registry is associated with lowerhemoglobin A1c levels than injection therapy.Pediatr Diabetes 2014;15:564–57291. LinMH,ConnorCG, RuedyKJ, et al.; PediatricDiabetes Consortium. Race, socioeconomic sta-tus, and treatment center are associated withinsulin pump therapy in youth in the first yearfollowing diagnosis of type 1 diabetes. DiabetesTechnol Ther 2013;15:929–93492. Willi SM, Miller KM, DiMeglio LA, et al.; T1DExchange Clinic Network. Racial-ethnic dispar-ities in management and outcomes among chil-dren with type 1 diabetes. Pediatrics 2015;135:424–43493. Redondo MJ, Libman I, Cheng P, et al.;Pediatric Diabetes Consortium. Racial/ethnicmi-nority youth with recent-onset type 1 diabeteshave poor prognostic factors. Diabetes Care2018;41:1017–102494. RamchandaniN, TenS,AnhaltH, et al. Insulinpump therapy from the time of diagnosis oftype 1 diabetes. Diabetes Technol Ther 2006;8:663–67095. Berghaeuser MA, Kapellen T, Heidtmann B,Haberland H, Klinkert C, Holl RW; German work-ing group for insulin pump treatment in paedi-atric patients. Continuous subcutaneous insulin

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