7. Diabetes Technology: Standards ofMedicalCareinDiabetes …(20.2%peradditionalcheckperday)and with fewer acute complications (13). Patients Using Basal Insulin and/or Oral Agents

7. Diabetes Technology: StandardsofMedical Care inDiabetesd2021Diabetes Care 2021;44(Suppl. 1):S85–S99 | https://doi.org/10.2337/dc21-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, a multidisciplinary expert committee (https://doi.org/10.2337/dc21-SPPC), are responsible for updating the Standards of Care annually, or morefrequently as warranted. For a detailed description of ADA standards, statements,and reports, as well as the evidence-grading system for ADA’s clinical practicerecommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc21-SINT). Readers who wish to comment on the Standards of Careare 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.

Recommendation

7.1 Useof technology shouldbe individualizedbasedonapatient’s needs, desires,skill level, and availability of devices. E

Technology is rapidly changing, but there is no “one-size-fits-all” approach totechnology use in people with diabetes. Insurance coverage can lag behind deviceavailability, patient interest in devices and willingness to change can vary, andproviders may have trouble keeping up with newly released technology. Not-for-profitwebsites can help providers and patients make decisions as to the initial choice ofdevices.Other sources, including health care providers anddevicemanufacturers, canhelp people troubleshoot when difficulties arise.

SELF-MONITORING OF BLOOD GLUCOSE

Recommendations

7.2 People who are on insulin using self-monitoring of blood glucose should beencouraged to testwhenappropriate basedon their insulin regimen. Thismay

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© 2020 by the American Diabetes Association.Readersmayuse this article as longas thework isproperly cited, the use is educational and not forprofit, and the work is not altered. More infor-mation is availableathttps://www.diabetesjournals.org/content/license.

American Diabetes Association

Diabetes Care Volume 44, Supplement 1, January 2021 S85

7.DIABETES

TECHNOLO

GY

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include testingwhenfasting,priorto meals and snacks, at bedtime,prior to exercise, when low bloodglucose is suspected, after treat-ing low blood glucose until theyare normoglycemic, and priorto and while performing criticaltasks such as driving. B

7.3 Providers should be aware of thedifferences in accuracy amongglu-cosemetersdonlyU.S. FoodandDrugAdministration–approvedme-ters with proven accuracy shouldbe used, with unexpired strips,purchased from a pharmacy orlicensed distributor. E

7.4 When prescribed as part of adiabetes self-management edu-cationandsupportprogram, self-monitoring of blood glucosemayhelp to guide treatment decisionsand/or self-management for pa-tients taking less frequent insulininjections. B

7.5 Although self-monitoring of bloodglucose in patients on noninsulintherapies has not consistentlyshown clinically significant reduc-tions in A1C, it may be helpfulwhen altering diet, physical ac-tivity, and/or medications (par-ticularly medications that cancause hypoglycemia) in conjunc-tion with a treatment adjustmentprogram. E

7.6 Whenprescribing self-monitoringof blood glucose, ensure thatpatients receive ongoing instruc-tion and regular evaluation oftechnique, results, and their abil-ity to use data, including upload-ing/sharing data (if applicable),from self-monitoring of blood glu-cose devices to adjust therapy. E

7.7 Health care providers should beaware of medications and otherfactors, such as high-dose vita-min C and hypoxemia, that caninterfere with glucose meter ac-curacy and provide clinical man-agement as indicated. E

Major clinical trials of insulin-treated pa-tients have included self-monitoring ofblood glucose (SMBG) as part of multi-factorial interventions to demonstratethe benefit of intensive glycemic con-trol on diabetes complications (1). SMBGis thusan integral componentof effective

therapy of patients taking insulin. In recentyears, continuous glucosemonitoring (CGM)hasemergedasamethodfortheassessmentof glucose levels (discussed below). Glucosemonitoring allows patients to evaluate theirindividual response to therapy and assesswhether glycemic targets are being safelyachieved. Integrating results into diabetesmanagement canbeauseful tool for guidingmedical nutrition therapy and physical ac-tivity, preventing hypoglycemia, or adjustingmedications (particularly prandial insulindoses). The patient’s specific needs andgoals should dictate SMBG frequency andtiming or the consideration of CGM use.

Meter StandardsGlucose meters meeting U.S. Food andDrug Administration (FDA) guidance formeter accuracy provide themost reliabledata for diabetes management. Thereare several current standards for accu-racy of blood glucose monitors, but thetwo most used are those of the Inter-national Organization for Standardization(ISO) (ISO 15197:2013) and the FDA. Thecurrent ISO and FDA standards are com-pared in Table 7.1. In Europe, currentlymarketedmonitorsmustmeet current ISOstandards. In the U.S., currently marketedmonitors must meet the standard underwhich theywere approved, whichmay notbe the current standard. Moreover, themonitoringof current accuracy is left to themanufacturer and not routinely checkedby an independent source.

Patients assume their glucosemonitoris accurate because it is FDA cleared, butoften that is not the case. There is sub-stantial variation in the accuracy of widelyused blood glucose monitoring systems(2,3). The Diabetes Technology SocietyBlood Glucose Monitoring System Sur-veillance Program provides informationon the performance of devices used forSMBG (https://diabetestechnology.org/surveillance). In one analysis, only 6 of thetop 18 glucose meters met the accuracystandard (4).

There are single-meter studies in whichbenefits have been found with individualmeter systems, but few that comparemeters in a head-to-head manner. Cer-tainmeter systemcharacteristics, suchasthe use of lancing devices that are lesspainful (5) and the ability to reapply bloodto a stripwith an insufficient initial sample,may also be beneficial to patients (6) andmay make SMBG less burdensome forpatients to perform.

Counterfeit Strips

Patients should be advised against pur-chasing or reselling preowned or second-handtest strips,as thesemaygive incorrectresults. Only unopened and unexpiredvials of glucose test strips should be usedto ensure SMBG accuracy.

Optimizing SMBG Monitor UseSMBG accuracy is dependent on the in-strument and user, so it is important toevaluate each patient’s monitoring tech-nique, both initially and at regular intervalsthereafter. Optimal use of SMBG requiresproper review and interpretation of thedata, by both the patient and the provider,to ensure that data are used in an effectiveand timely manner. In patients with type 1diabetes, there is a correlation betweengreater SMBG frequency and lower A1C(7). Among patients who check their bloodglucose at least once daily, many reporttaking no action when results are high orlow (8). Patients should be taught how touse SMBG data to adjust food intake,exercise, or pharmacologic therapy toachieve specific goals. Somemeters nowprovide advice to the user in real time,when monitoring glucose levels (9), whileothers can be used as a part of integratedhealth platforms (10).

Theongoing need for and frequency ofSMBG should be reevaluated at each rou-tine visit to avoid overuse, particularly ifSMBG is not being used effectively forself-management (8,11,12).

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/orCGM) prior to meals and snacks, at bed-time, occasionally postprandially, prior toexercise, when they suspect low bloodglucose, after treating low blood glucoseuntil they are normoglycemic, and priorto and while performing critical taskssuch as driving. Formany patients usingSMBG, this will require checking up to6–10 times daily, although individualneeds may vary. A database study ofalmost 27,000 children and adolescentswith type 1 diabetes showed that, afteradjustment for multiple confounders, in-creased daily frequency of SMBG wassignificantly associated with lower A1C

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(20.2% per additional check per day) andwith fewer acute complications (13).

Patients Using Basal Insulin and/or Oral

Agents

The evidence is insufficient regardingwhen to prescribe SMBG and how oftenmonitoring is needed for insulin-treatedpatients who do not use intensive insulinregimens, such as those with type 2 di-abetes using basal insulin with or withoutoral agents. However, for patients usingbasal insulin, assessing fasting glucosewith SMBG to inform dose adjustmentsto achieve blood glucose targets resultsin lower A1C (14,15).In people with type 2 diabetes not

using insulin, routine glucose monitoringmay be of limited additional clinicalbenefit. By itself, even when combinedwith education, it has showed limitedimprovement inoutcomes (16–19).How-ever, for some individuals, glucose mon-itoring can provide insight into theimpact of diet, physical activity, andmedication management on glucoselevels. Glucose monitoring may also beuseful in assessing hypoglycemia, glu-cose levels during intercurrent illness,or discrepancies between measuredA1C and glucose levels when there isconcern anA1C resultmaynot be reliablein specific individuals. It may be usefulwhen coupled with a treatment adjust-ment program. In a year-long study ofinsulin-naive patients with suboptimal ini-tial glycemic stability, a group trained instructured SMBG (a paper toolwas used atleast quarterly to collect and interpretseven-point SMBGprofiles taken on 3 con-secutive days) reduced their A1C by 0.3%more than thecontrol group (20).A trial ofonce-daily SMBG that included en-hanced patient feedback through mes-saging found no clinically or statisticallysignificant change in A1C at 1 year (19).Meta-analyses have suggested that

SMBG can reduce A1C by 0.25–0.3%at 6 months (21–23), but the effect wasattenuatedat12months inoneanalysis (21).Reductions in A1C were greater (20.3%) intrialswherestructuredSMBGdatawereusedto adjust medications, but A1C was notchangedsignificantlywithoutsuchstructureddiabetes therapy adjustment (23). A keyconsideration is thatperformingSMBGalonedoes not lower blood glucose levels. To beuseful, the information must be integratedinto clinical and self-management plans.

Glucose Meter Inaccuracy

Although many meters function wellunder a variety of circumstances, providersandpeoplewithdiabetesneed tobeawareof factors thatcan impairmeteraccuracy.Ameter reading that seems discordant withclinical reality needs to be retested ortested in a laboratory. Providers in inten-sive care unit settings need to be partic-ularly aware of the potential for abnormalmeter readings, and laboratory-based val-ues should be used if there is any doubt.Somemeters give error messages if meterreadings are likely to be false (24).Oxygen. Currently available glucosemonitors utilize an enzymatic reactionlinked to an electrochemical reaction, ei-ther glucose oxidase or glucose dehydro-genase (25). Glucose oxidase monitorsare sensitive to the oxygen available andshould only be usedwith capillary blood inpatients with normal oxygen saturation.Higher oxygen tensions (i.e., arterial bloodor oxygen therapy) may result in false lowglucose readings, and low oxygen tensions(i.e.,highaltitude,hypoxia,orvenousbloodreadings) may lead to false high glucosereadings. Glucose dehydrogenase–basedmonitors are not sensitive to oxygen.Temperature.Because the reaction is sen-sitive to temperature, all monitors havean acceptable temperature range (25).Mostwill showanerror if the temperatureis unacceptable, but a fewwill provide a

readingandamessage indicating that thevalue may be incorrect.Interfering Substances. There are a fewphysiologic and pharmacologic factorsthat interfere with glucose readings. Mostinterfere only with glucose oxidase sys-tems (25). They are listed in Table 7.2.

CONTINUOUS GLUCOSEMONITORING DEVICES

See Table 7.3 for definitions of types ofCGM devices.

Recommendations

7.8 Whenprescribing continuous glu-cosemonitoring (CGM)devices,robust diabetes education, train-ing, and support are required foroptimal CGMdevice implementa-tionandongoinguse.PeopleusingCGM devices need to have theability to perform self-monitoringof blood glucose in order tocalibrate their monitor and/orverify readings if discordant from

their symptoms. B7.9 When used properly, real-time

continuous glucose monitors inconjunction with multiple dailyinjections and continuous subcu-taneous insulin infusion A andother forms of insulin therapy Care a useful tool to lower and/ormaintainA1C levels and/or reduce

Table 7.1—Comparison of ISO 15197:2013 and FDA blood glucose meter accuracy standards

Setting FDA (206,207) ISO 15197:2013 (208)

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,see http://endmemo.com/medical/unitconvert/Glucose.php. †The range of blood glucose values forwhich themeter has been proven accurateand will provide readings (other than low, high, or error). ‡Values outside of the “clinically acceptable” A and B regions are considered “outlier”readings and may be dangerous to use for therapeutic decisions (209).

Table 7.2—Interfering substances forglucose readings

Glucose oxidase monitorsUric acidGalactoseXyloseAcetaminophenL-DOPAAscorbic acid

Glucose dehydrogenase monitorsIcodextrin (used in peritoneal dialysis)

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hypoglycemia in adults and youthwith diabetes.

7.10 When used properly, intermit-tentlyscannedcontinuousglucosemonitors in conjunctionwithmul-tiple daily injections and continu-ous subcutaneous insulin infusionB and other forms of insulin ther-apyCcanbeuseful andmay lowerA1C levels and/or reduce hypo-glycemia inadultsandyouthwithdiabetes to replace self-monitor-ing of blood glucose.

7.11 In patients on multiple dailyinjections and continuous subcu-taneous insulin infusion, real-timecontinuous glucose monitoring(CGM)devices shouldbeusedasclose to daily as possible formaximal benefit.A Intermittentlyscanned CGM devices should bescanned frequently, at aminimumonce every 8 h.

7.12 Whenused as an adjunct to pre-and postprandial self-monitor-ing of blood glucose, continu-ous glucose monitoring can helpto achieveA1C targets in diabetesand pregnancy. B

7.13 Use of professional continuousglucosemonitoring (CGM) and/orintermittent real-time or intermit-tentlyscannedCGMcanbehelpfulin identifying and correcting pat-terns of hyper- and hypoglycemiaand improving A1C levels in peo-plewith diabetes on noninsulin aswell as basal insulin regimens. C

7.14 Skin reactions, either due to irri-tation or allergy, should be as-sessed and addressed to aid insuccessful use of devices. E

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

CGM measures interstitial glucose (whichcorrelates well with plasma glucose, al-thoughat times can lag if glucose levels arerising or falling rapidly). There are twobasic types of CGM devices: those thatare owned by the user, unblinded, andintended for frequent/continuous use(real-time [rt]CGM and intermittentlyscanned [is]CGM) and those that areownedandapplied in/by the clinic,whichprovide data that is blinded or unblindedfor a discrete periodof time (professionalCGM). Table 7.3 provides the definitionsfor the types of CGMdevices. For devicesthat provide patients unblinded data,most of the published randomized con-trolled trials (RCTs) havebeen performedusing rtCGM devices that have alarmsand alerts. The RCT results have largelybeen positive, in terms of reducing eitherA1C levels and/or episodes of hypogly-cemia, as long as participants regularlywear the devices (26–29). These devicesprovide glucose readings continuouslyto a smartphone or reader that can beviewed by the patient and/or a care-giver. It is difficult to determine howmuch the need to swipe a device toobtain a result, combined with a lack ofalarms and alerts, matters in terms ofoutcomes, although results from thesedevices (isCGM) have not shown con-sistent improvements in glycemic out-comes (30).However, data from longitudinaltrials (without a control group for com-parison) show improvement inA1C levels(31). There is one small study in patientsat risk for hypoglycemia that comparedrtCGMwith isCGM (32). The study showedimprovement in time spent in hypoglyce-mia with rtCGM compared with isCGM.The newest version of the isCGM systemhas an optional alert for a high or lowglucose value (without the capacity forproviding predictive alerts), but it stillrequires that the device be swiped toreveal theglucose level and trendarrows,and RCT data are lacking in terms of

added benefit. This device (FreeStyleLibre 2) and one rtCGM (Dexcom G6)have both been designated as integratedcontinuous glucose monitoring (iCGM)devices (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id5682). This is a higher standard,set by the FDA, so these devices can bereliably integratedwith other digitally con-nected devices, including automated in-sulin dosing systems.

Some real-time systems require cali-bration by the user, which varies in fre-quencydependingonthedevice.Additionally,for some CGMsystems, the FDA suggestsSMBG for making treatment decisions.Devices that require SMBG confirmationare called “adjunctive,” while those thatdo not are called “nonadjunctive.” AnRCT of 226 adults suggested that a CGMdevice could be used safely and effec-tivelywithout regular confirmatory SMBGin patients with well-controlled type 1diabetes at low risk of severe hypoglyce-mia (33). Two CGM devices are approvedby the FDA for making treatment deci-sions without SMBG calibration or con-firmation (34,35). For patients withtype 1 diabetes using rtCGM, an impor-tant predictor of A1C lowering for all age-groupswas frequencyof sensoruse (26). Inthis study, overall use was highest in thoseaged $25 years (who had the most im-provement in A1C) and lower in youngerage-groups.

The abundance of data provided byCGM offers opportunities to analyzepatient data more granularly than waspreviously possible, providing additionalinformation to aid in achieving glycemictargets. A variety of metrics have beenproposed (27) and are discussed in Sec-tion 6 “Glycemic Targets” (https://doi.org/10.2337/dc21 -S006). CGM is es-sential for creating the ambulatory glu-cose profile (AGP) and providing data ontime in range, percentage of time spentabove and below range, and variability

Table 7.3—Continuous glucose monitoring (CGM) devices

Type of CGM Description

Real-time CGM (rtCGM) CGM systems that measure and display glucose levels continuously

Intermittently scanned CGM (isCGM) CGM systems that measure glucose levels continuously but only display glucose values when swipedby a reader or a smartphone

Professional CGM CGMdevices thatareplacedonthepatient in theprovider’soffice (orwith remote instruction)andwornfor a discrete period of time (generally 7–14 days). Data may be blinded or visible to the personwearing the device. The data are used to assess glycemic patterns and trends. These devices are notfully ownedby the patientdthey are a clinic-based device, as opposed to the patient-owned rtCGM/isCGM devices.

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(36). Access to CGM devices should beconsidered from the outset of the di-agnosis of diabetes that requires insulinmanagement (37,38). This allows forclose tracking of glucose levels withadjustments of insulin dosing and life-style modifications and removes theburden of frequent SMBG monitoring.Interruption of access to CGM is asso-ciated with a worsening of outcomes(39); therefore, it is important for indi-viduals on CGM to have consistent accessto the devices.

Education and TrainingIn general, no device used in diabetesmanagement works optimally withouteducation, training, and follow-up. De-vice companies offer online tutorials andtraining videos aswell aswrittenmaterialon their use. Patients vary in terms ofcomfort level with technology, and someprefer in-person training and support.Programs that involve training andsupport have been shown to improveoutcomes in both adults and childrenusing isCGM (40–42). Individuals usingCGM should also be trained on how touse SMBG, for use with devices that re-quire calibration, for testing if CGMvaluesseemincongruentwiththepatient’ssenseof their glucose levels, and if the CGMdevice fails or is not available.

Real-time CGM Device Use in Adultsand Children With DiabetesData exist to support the use of real-timeCGM in adults and children, both thoseon multiple daily injections (MDI) andthose on continuous subcutaneous in-sulin infusion (CSII). This is true in studiesboth in people with type 1 diabetes andthosewith type2diabetes, althoughdatain individuals with type 2 diabetes isprimarily in adults.In terms of RCTs in people with type 1

diabetes, there are four studies in adultswith A1C as the primary outcome(28,29,43–45), three studies in adultswith hypoglycemia as the primary out-come (46–48), four studies in adultsand children with A1C as the primaryoutcome (26,49–51), and three studiesin adults and children with hypoglyce-mia as a primary outcome (52–54).

Primary Outcome: A1C ReductiondAdults

In general, A1C reduction was shown instudies where the baseline A1C washigher. In two larger studies in adultswith type 1 diabetes that assessed the

benefit of rtCGM in patients on MDI,there were significant reductions in A1C:20.6% in one (28,43) and20.43% in theother (29). No reduction in A1C was seenin a small study performed in under-served, less well-educated adults withtype 1 diabetes (44). In the adult subsetof the JDRF CGM study, there was asignificant reduction in A1C of 20.53%(55) in patients who were primarily trea-ted with insulin pump therapy. Betteradherence in wearing the rtCGM deviceresulted in a greater likelihood of animprovement in glycemic control (26,45).

Primary Outcome: HypoglycemiadAdults

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 (46–48). Inone study in patients who were at higherrisk for episodes of hypoglycemia (48),therewas a reduction in rates of all levelsof hypoglycemia (see Section 6 “GlycemicTargets,” https://doi.org/10.2337/dc21-S006, for hypoglycemia definitions). rtCGMmay be particularly useful in insulin-treated patients with hypoglycemiaunawareness and/or frequent hypogly-cemic episodes, although studies havenot been powered to show consistentreductions in severe (level 3) hypogly-cemia (26,49,50).

Impact on Glycemic ControldChildren

When data from adult and pediatricparticipants are analyzed together,rtCGM use in RCTs has been associatedwith reduction in A1C levels (49–51). Yet,in the JDRF CGM trial, when youth wereanalyzedbyage-group (8- to14-year-oldsand 15- to 24-year-olds), no change inA1C was seen, likely due to poor rtCGMadherence (26). Indeed, in a secondaryanalysis of that RCT’s data in both pedi-atric cohorts, those who used the sensor$6days/week had an improvement in theirglycemic control (56). One critical com-ponent to success with CGM is near-daily wearing of the device (49,55,57–59). One RCT showed no improve-ment in glycemic outcomes in children aged4–10 years of age, regardless of howoften itwas worn (60).

Though data from small observationalstudies demonstrate that rtCGM can beworn by patients,8 years old and the useof rtCGM provides insight to glycemic pat-terns (61,62), an RCT in children aged 4–9years did not demonstrate improvements

in glycemic control following 6 months ofrtCGM use (60). However, observationalfeasibility studies of toddlers demonstrateda high degree of parental satisfaction andsustained use of the devices despite theinability to change the degree of glycemiccontrol attained (63).

Registry data have also shown anassociation between rtCGM use andlower A1C levels (55,64), even whenlimiting assessment of rtCGM use toparticipants on injection therapy (64).

Impact on HypoglycemiadChildren

There are no studies solely includingpediatric patients that assess rates ofhypoglycemia as the primary outcome.Some of the studies where pediatric andadult patients were combined togetherdid show potential reductions in hypo-glycemia (16,65,66).

Real-time CGM Use in Type 2 DiabetesStudies inpeoplewith type2diabetes areheterogeneous in design: in two, partic-ipants were using basal insulin with oralagents or oral agents alone (67,68); inone, individuals were on MDI alone (69).The findings in studies with MDI alone(69) and in two studies in people usingoral agents with or without insulin(67,68) showed significant reductionsin A1C levels. The Multiple Daily Injec-tions and Continuous Glucose Monitor-ing in Diabetes (DIAMOND) study inpeople with type 2 diabetes on MDIshowed a reduction in A1C but no re-duction in hypoglycemia (69). Studies inindividuals with type 2 diabetes on oralagents with or without insulin did notshowreductions in ratesof hypoglycemia(67,68).

Intermittently Scanned CGM DeviceUse in Adults and Children WithDiabetesThe original isCGM device (to which themajority of the published data applies)didnotprovidealarmsandalerts but is anoption used by many patients. There arerelatively few RCT data proving benefitin people with diabetes, but there aremultiple longitudinal and observationalstudies. One RCT, designed to show areduction in episodes of hypoglycemia inpatients with type 1 diabetes at higherrisk for hypoglycemia, showed a signif-icant benefit in terms of time spent in ahypoglycemic range (P , 0.0001) (46).Another RCT, assessing the ability of

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isCGM to prevent episodes of recurrent,severe hypoglycemia, showed no benefit(70). In one RCT of isCGM in people withtype 2 diabetes on a variety of insulinregimens and with an initial A1C of;8.8%, no reduction in A1C was seen;however, the time spent in a hypogly-cemic range was reduced by 43% (71).In a study of isCGM in individuals withtype 2 diabetes on MDI, the A1C wasreduced by 0.82% in the interventiongroup and 0.33% in the control group(P 5 0.005) with no change in rates ofhypoglycemia (72). Multiple observa-tional studies have shown benefit interms of A1C reduction, reductions inhypoglycemia, and/or improvements inquality of life in both children and adults(31,41,73–78). An observational studyfrom Belgium showed no improvementsin A1C or quality of life after a year ofisCGM use, with a reduction in episodesof severe hypoglycemia and time absentfrom work compared with patient recallof events during the 6 months prior tostarting CGM (79).There are several published reviews of

data available on isCGM (80–83). TheNorwegian Institute of Public Healthconducted an assessment of isCGMclinical effectiveness, cost-effectiveness,and safety for individuals with type 1and type 2 diabetes, based on data avail-able to January 2017 (80). The authorsconcluded that, although there werefew quality data available at the timeof the report, isCGMmay increase treat-ment satisfaction, increase time in range,and reduce frequency of nocturnal hy-poglycemia, without differences in A1Cor quality of life or serious adverseevents. The Canadian Agency for Drugsand Technologies in Health reviewedexisting data on isCGM performanceand accuracy, hypoglycemia, effect onA1C, and patient satisfaction and qualityof life and concluded that the systemcould replace SMBG, particularly in pa-tients who require frequent monitoring(81). A 2020 systematic review of RCTsassessing efficacy and patient satisfac-tionwith isCGMrevealed improvementsin A1C levels in some subgroups ofpatients (e.g., those with type 2 diabe-tes) but concluded that additional ben-efit in terms of time in range, glycemicvariability, and hypoglycemia was un-clear (30). Benefit was enhanced inindividuals with type 1 diabetes whencombined with a structured education

program. Another review showed somebenefits in terms of A1C reduction as wellas improvement in quality of life (84). Areview that included studies conductedusing a variety of trial designs, includingprospective and retrospective cohort stud-ies, showed overall a reduction in A1C(20.26%) in people with type 1 andtype 2 diabetes, but there was no differ-ence in time in range or hypoglycemicepisodes (83).

Other benefits are discussed in a re-view (82) that supported the use of isCGMas a more affordable alternative to rtCGMsystems for individuals with diabetes whoare on intensive insulin therapy. In manycases, isCGM is the preferred alternativecompared with SMBG (85,86). It can alsoimproveadherencetomonitoring inpatientswho are in extremely poor control (87).

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 using CGM in addition to stan-dard care, including optimization of pre-and postprandial glucose targets (88). Itdemonstrated the value of CGM inpregnancy complicated by type 1 di-abetes by showing a mild improvementin A1C without an increase in hypogly-cemia as well as reductions in large-for-gestational-age births, length of stay,and neonatal hypoglycemia (88). Anobservational cohort study that evalu-ated the glycemic variables reportedusing CGM found that lower meanglucose, lower standard deviation,and a higher percentage of time intarget range were associated withlower risk of large-for-gestational-agebirths and other adverse neonatal out-comes (89). Use of the CGM-reportedmean glucose is superior to use ofestimated A1C, glucose managementindicator, and other calculations to es-timate A1C given the changes toA1C thatoccur in pregnancy (90). Two studiesemploying intermittent use of rtCGMshowed no difference in neonatal out-comes in women with type 1 diabetes(91) or gestational diabetes mellitus (92).

Use of Professional and IntermittentCGMProfessional CGMdevices, which provideretrospective data, either blinded or un-blinded, for analysis, can be used to

identify patterns of hypo- and hypergly-cemia (93). Professional CGM can behelpful to evaluate patients when eitherrtCGM or isCGM is not available to thepatient or the patient prefers a blindedanalysis or a shorter experience withunblinded data. It can be particularlyuseful to evaluate periods of hypoglyce-mia in patients on agents that can causehypoglycemia in order to make medica-tion dose adjustments. It can also beuseful to evaluate patients for periods ofhyperglycemia.

There are some data showing benefitof intermittent use of CGM (rtCGMor isCGM) in individuals with type 2diabetes on noninsulin and/or basalinsulin therapies (68,94). In these RCTs,patients with type 2 diabetes not onintensive insulin regimens used CGMintermittently compared with patientsrandomized to SMBG.Bothearly (68) andlate improvements in A1C were found(68,94).

Useof professional or intermittent CGMshould always be coupled with analysisand interpretation for the patient,along with education as needed toadjust medication and change lifestylebehaviors.

Side Effects of CGM DevicesContact dermatitis (both irritant andallergic) has been reported with alldevices that attach to the skin(95–97). In some cases this has beenlinked to the presence of isobornylacrylate, which is a skin sensitizer andcan cause an additional spreading allergicreaction (98–100). Patch testing can bedone to identify the cause of the contactdermatitis in some cases (101). Identify-ing and eliminating tape allergens isimportant to ensure comfortable useof devices and enhance patient adher-ence (102–105). In some instances, use ofan implanted sensor can help avoid skinreactions in those who are sensitive totape (106,107).

INSULIN DELIVERY

Insulin Syringes and Pens

Recommendations

7.16 For people with diabetes who re-quire insulin, insulin syringes orinsulin pens may be used forinsulin delivery with consider-ation of patient preference, in-sulin type and dosing regimen,

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cost, and self-management ca-pabilities. B

7.17 Insulinpensor insulin injectionaidsmay be considered for patientswith dexterity issues or visionimpairment to facilitate the ad-ministration of accurate insulindoses. C

7.18 Smartpensmaybeusefulforsomepatients to helpwith dose captureand dosing recommendations. E

7.19 U.S.FoodandDrugAdministration–approved insulin dose calcula-tors/decision support systemsmaybehelpful for titrating insulindoses. E

Injecting insulin with a syringe or pen isthe insulin deliverymethod used bymostpeoplewithdiabetes (108,109), 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(110–112),while insulin injectionaids arealso available to help with these issues.(For a helpful list of injection aids, seehttp://main.diabetes.org/dforg/pdfs/2018/2018-cg-injection-aids.pdf.) In-haled insulin can be useful in peoplewho have an aversion to injections.The most common syringe sizes are

1mL, 0.5mL, and 0.3mL, allowing doses ofup to 100 units, 50 units, and 30 units ofU-100 insulin, respectively. In a few partsof the world, insulin syringes still haveU-80 and U-40 markings for older insu-lin concentrations and veterinary insulin,and U-500 syringes are available for theuse of U-500 insulin. Syringes are gen-erally used once but may be reused bythe same individual in resource-limited

settings with appropriate storage andcleansing (113).

Insulin pens offer added convenienceby combining the vial and syringe intoa single device. Insulin pens, allowingpush-button injections, come as dispos-able pens with prefilled cartridges or re-usable insulinpenswith replaceable insulincartridges.Pensvarywith respect todosingincrement and minimal dose, which canrange from half-unit doses to 2-unit doseincrements.U-500penscome in5-unitdoseincrements. Some reusable pens include amemory function, which can recall doseamountsandtiming.“Smart”pens that canbe programmed to calculate insulin dosesand provide downloadable data reports arealsoavailable.Thesepensareuseful toassistpatient insulin dosing in real time as well asfor allowing clinicians to retrospectively re-view the insulin doses that were given andmake insulin dose adjustments (114).

Needle thickness (gauge) and length isanother 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 someevidence suggestingshorter needles may lower the risk ofintramuscular injection.Whenreused,nee-dlesmay be duller and thus injectionmorepainful. Proper insulin injection techniqueis a requisite for obtaining the full benefitsof insulintherapy.Concernswithtechniqueand use of the proper technique are out-lined in Section 9 “Pharmacologic Ap-proaches to Glycemic Treatment” (https://doi.org/10.2337/dc21-S009).

Bolus calculatorshavebeendevelopedto aid in dosing decisions (115–119). 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

7.20 Insulin pump therapymay be con-sidered as an option for all adultsand youth with type 1 diabeteswho are able to safely managethe device. A

7.21 Insulin pump therapymay be con-sidered as an option for adults andyouth with type 2 diabetes andotherformsofdiabeteswhoareonmultiple daily injections who areabletosafelymanagethedevice.B

7.22 Individualswithdiabeteswhohavebeen successfully using contin-uous subcutaneous insulin infu-sion should have continued accessacross third-party payers. E

CSII, or insulin pumps, have been avail-able in the U.S. for over 40 years. Thesedevices deliver rapid-acting insulin through-out the day to help manage blood glucoselevels. Most insulin pumps use tubing todeliver insulin through a cannula, while afew attach directly to the skin, withouttubing.

Most studies comparing MDI with CSIIhave 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 hy-poglycemia rates in children and adults(120). There is no consensus to guidechoosing which form of insulin adminis-tration is best for a given patient, andresearch to guide this decision-making isneeded (121). Thus, the choice of MDI oran insulin pump is often based upon theindividual characteristics of the patientandwhich ismost likely to benefit them.Newersystems, suchas sensor-augmentedpumps and automatic insulin deliverysystems, are discussed elsewhere in thissection.

Adoption of pump therapy in the U.S.shows geographical variations, which maybe related toproviderpreferenceor centercharacteristics (122,123) and socioeco-nomic status, as pump therapy is morecommon in individuals of higher socio-economic status as reflected by race/ethnicity, private health insurance, fam-ily income, and education (123,124).Given the additional barriers to optimaldiabetes care observed in disadvantagedgroups (125), addressing the differencesin access to insulin pumps and otherdiabetes technology may contribute tofewer health disparities.

Pumptherapycanbesuccessfully startedat the time of diagnosis (126,127). Practicalaspects of pump therapy initiation in-clude assessment of patient and family

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readiness (although there is no consen-sus onwhich factors to consider in adults[128] or pediatric patients), selection ofpump type and initial pump settings,patient/family education of potentialpump complications (e.g., diabetic ke-toacidosis [DKA] with infusion set failure),transition from MDI, and introduction ofadvanced pump settings (e.g., temporarybasal rates, extended/square/dual wavebolus).Older individuals with type 1 diabetes

benefit from ongoing insulin pump ther-apy. There are no data to suggest thatmeasurement of C-peptide levels or anti-bodies predicts success with insulin pumptherapy (129,130). Additionally, frequencyof follow-up does not influence outcomes.Access to insulin pump therapy should beallowed/continued in older adults as it is inyounger people.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 thusmust be recognized and managed early(131); lipohypertrophy or, less frequently,lipoatrophy (132,133); and pump siteinfection (134). Discontinuation of pumptherapy is relatively uncommon today;the frequency has decreased over thepast few decades, and its causes havechanged (134,135). Current reasons forattrition are problems with cost, wear-ability, dislike for the pump, suboptimalglycemic control, ormooddisorders (e.g.,anxiety or depression) (136).

Insulin Pumps in YouthThe safety of insulin pumps in youth hasbeen established for over 15 years (137).Studying the effectiveness of CSII in low-ering A1C has been challenging becauseof the potential selection bias of obser-vational studies. Participants on CSII mayhave a higher socioeconomic status thatmay facilitate better glycemic control(138) versus MDI. In addition, the fastpace of development of new insulins andtechnologies quickly renders compari-sons obsolete. However, RCTs compar-ing CSII and MDI with insulin analogsdemonstrate a modest improvement inA1C in participants on CSII (139,140). Ob-servational studies, registry data, andmeta-analysis have also suggested an im-provement of glycemic control in partic-ipants on CSII (141–143). Althoughhypoglycemia was a major adverse ef-fect of intensified insulin regimen in the

Diabetes Control and Complications Trial(DCCT) (144), data suggest that CSII mayreduce the rates of severe hypoglycemiacompared with MDI (143,145–147).

There is also evidence that CSII mayreduce DKA risk (143,148) and diabetescomplications, in particular, retinopathyand peripheral neuropathy in youth,compared with MDI (65). Finally, treat-ment satisfaction and quality-of-life mea-sures improved on CSII compared withMDI (149,150). Therefore, CSII can beused safely and effectively in youth withtype 1 diabetes to assist with achievingtargeted glycemic control while reduc-ing the risk of hypoglycemia and DKA,improving quality of life, and prevent-ing long-term complications. Based onpatient–provider shared decision-making,insulin pumps may be considered in allpediatric patients with type 1 diabetes.In particular, pump therapy may bethe preferred mode of insulin deliveryfor children under 7 years of age (66).Because of a paucity of data in adoles-cents and youth with type 2 diabetes,there is insufficient evidence to makerecommendations.

Common barriers to pump therapyadoption in children and adolescents areconcerns regarding the physical interfer-ence of the device, discomfort with theidea of having a device on the body,therapeutic effectiveness, and financialburden (141,151).

Insulin Pumps in Patients With Type 2and Other Types of DiabetesTraditional insulin pumps can be consid-ered for the treatment of people withtype2diabeteswhoare onMDI aswell asthose who have other types of diabetesresulting in insulin deficiency, for in-stance, those who have had a pancrea-tectomy and/or individuals with cysticfibrosis (152–156). Similar to data oninsulin pump use in people with type 1diabetes, reductions in A1C levels are notconsistently seen in individuals withtype 2 diabetes when compared withMDI, although they have been in somestudies (154,157).Useof insulinpumps ininsulin-requiring patients with any typeof diabetes may improve patient satis-faction and simplify therapy (130,152).

Forpatients judgedtobeclinically insulindeficient who are treated with an in-tensive insulin regimen, the presence orabsence of measurable C-peptide levelsdoes not correlate with response to

therapy (130). Another pump option inpeople with type 2 diabetes is a dispos-able patchlike device, which provides acontinuous, subcutaneous infusion ofrapid-acting insulin (basal) as well as2-unit increments of bolus insulin atthe press of a button (153,155,158).Use of an insulin pump as a means forinsulin delivery is an individual choice forpeople with diabetes and should beconsidered an option in patients whoare capable of safely using the device.

Combined Insulin Pump and SensorSystems

Recommendations

7.23 Sensor-augmentedpumptherapywith automatic low glucose sus-pend may be considered foradults and youth with diabetesto prevent/mitigate episodes ofhypoglycemia. B

7.24 Automated insulin delivery sys-temsmaybe considered in youthand adults with type 1 diabetesto improve glycemic control. A

7.25 Individual patients may be usingsystemsnot approvedby theU.S.Food and Drug Administration,suchasdo-it-yourself closed-loopsystems and others; providerscannot prescribe these systemsbut should provide safety infor-mation/troubleshooting/backupadvice for the individual devicesto enhance patient safety. E

Sensor-Augmented Pumps

Sensor-augmented pumps that suspendinsulin when glucose is low or predictedto 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 function sig-nificantly reduced nocturnal hypoglyce-mia over 3 months without increasingA1C levels (51). In a different sensor-augmentedpump,predictive lowglucosesuspend reduced timespentwithglucose,70mg/dL from3.6%atbaseline to2.6%(3.2% with sensor-augmented pumptherapy without predictive low glucosesuspend) without rebound hyperglyce-mia during a 6-week randomized cross-over trial (159). These devices may offer

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the opportunity to reduce hypoglycemiafor those with a history of nocturnal hy-poglycemia. Additional studies have beenperformed, in adults and children, showingthe benefits of this technology (160–162).

Automated Insulin Delivery Systems

Automated insulin delivery systems in-crease and decrease insulin deliverybased on sensor-derived glucose levelto begin to approximate physiologic in-sulin delivery. These systems consist ofthree components: an insulin pump, acontinuous glucose sensor, and an algo-rithm that determines insulin delivery.With these systems, insulin delivery cannot only be suspended but also increasedor decreased based on sensor glucosevalues. While eventually insulin deliveryin closed-loop systems may be trulyautomated, currently meals must be an-nounced. A so-called hybrid approach,hybrid closed-loop, has been adoptedin first-generation closed-loop systemsand requires users to bolus for mealsandsnacks.Multiplestudies,usingavarietyof systems with varying algorithms, pump,and sensors, have been performed inadults and children (163–173). Evidencesuggests such systems may reduce A1Clevels and improve time in range (174–178). They may lower the risk of exercise-related hypoglycemia (179) and may havepsychosocial benefits (180–183). Use ofthese systems depends on patient prefer-ence 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 anrtCGMwith a controller and an algorithmdesigned to automate insulin delivery(184–187). These systems are not ap-proved by the FDA, although there areefforts underway to obtain regulatoryapproval for them. The information onhow to set up andmanage these systemsis freely available on the internet, andthere are internet groups where peopleinform each other as to how to set up anduse them. Although these systems cannotbe prescribed by providers, it is importantto keep patients safe if they are usingthese methods for automated insulin de-livery. Part of this entails making surepeople have a “backup plan” in case ofpump failure. Additionally, in most DIYsystems, insulin doses are adjusted basedon the pump settings for basal rates,

carbohydrate ratios, correction doses,and insulin activity. Therefore, these set-tings canbeevaluatedand changedbasedon the patient’s insulin requirements.

Digital Health Technology

Recommendation

7.26 Systems that combine technologyand online coaching can be ben-eficial in treating prediabetes anddiabetes for some individuals. B

Increasingly, 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 technologies in-tended to treat a medical or psycholog-ical condition; these are known as digitaltherapeutics or “digiceuticals” (188).Otherapplications, such as those that assist indisplaying or storing data, encourage ahealthy lifestyle or provide limited clinicaldata support. Therefore, it is possible tofind apps that have been fully reviewedand approved and others designed andpromoted by peoplewith relatively littleskill or knowledge in the clinical treat-ment of diabetes.

An area of particular importance isthat of online privacy and security. Thereare established cloud-based data collec-tion programs, such as Tidepool, Glooko,and others, that have been developedwith appropriate data security featuresand are compliant with the U.S. HealthInsurance Portability and AccountabilityAct of 1996. These programs can beuseful for monitoring patients, both bythe patients themselves as well as theirhealth care team (189). Consumers shouldread the policy regarding data privacy andsharing before entering data into an ap-plication and learn how they can controlthe way their data will be used (someprograms offer the ability to sharemore orless information, such as being part of aregistry or data repository or not).

There are many online programs thatoffer lifestyle counseling to aidwithweightloss and increase physical activity (190).Many of these include a health coach andcan create small groups of similar patientsin socialnetworks.Thereareprogramsthataim to treat prediabetes and prevent pro-gression to diabetes, often following themodel of theDiabetes PreventionProgram

(191,192). Others assist in improving di-abetes outcomes by remotely monitoringpatient clinical data (for instance, wirelessmonitoring of glucose levels, weight, orblood pressure) and providing feedbackand coaching (193–198). There are textmessaging approaches that tie into a va-riety of different types of lifestyle andtreatment programs, which vary in termsof their effectiveness (199,200). For manyof these interventions, there are limitedRCT data and long-term follow-up is lack-ing. But for an individual patient, optinginto one of these programs can be helpfuland, for many, is an attractive option.

Inpatient Care

Recommendation

7.27 Patients using diabetes devicesshould be allowed to use themin an inpatient setting whenproper supervision is available. E

Patients who are comfortable using theirdiabetes devices, such as insulin pumpsandsensors, shouldbegiventhechancetouse them in an inpatient setting if they arecompetent to do so (201,202). Patientswho are familiar with treating their ownglucose levels can often adjust insulindoses more knowledgably than inpatientstaff who do not personally know thepatient or their management style. How-ever, 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.

With the advent of the coronavirusdisease 2019 pandemic, the FDA hasallowed CGM use in the hospital forpatient monitoring (203). This approachhas been employed to reduce the use ofpersonal protective equipment and moreclosely monitor patients, so that medicalpersonnel do not have to go into a patientroomsolely for thepurposeofmeasuring aglucose level. Studies are underway toassess the effectiveness of this approach,whichmay ultimately lead to the routineuse of CGM for monitoring hospitalizedpatients (204,205).

The FutureThe pace of development in diabetestechnology is extremely rapid. New

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approaches 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 appropri-ate for the individual. Simply having adevice or application does not changeoutcomes unless the human being en-gages with it to create positive healthbenefits. This underscores the need forthe health care team to assist thepatient in device/program selection andto support its use through ongoing ed-ucation and training. Expectations mustbe tempered by realitydwe do not yethave technology that completely elimi-nates the self-care tasks necessary fortreating diabetes, but the tools describedin this section can make it easier tomanage.

References1. Diabetes Control and Complications Trial Re-search Group; Nathan DM, Genuth S, Lachin J,et al. The effect of intensive treatment of diabeteson the development and progression of long-term complications in insulin-dependent diabe-tes mellitus. N Engl J Med 1993;329:977–9862. King F, Ahn D, Hsiao V, Porco T, Klonoff DC. Areview of blood glucose monitor accuracy.Diabetes Technol Ther 2018;20:843–8563. Brazg RL, Klaff LJ, Parkin CG. Performancevariability of seven commonly used self-moni-toring of blood glucose systems: clinical consid-erations for patients and providers. J DiabetesSci Technol 2013;7:144–1524. Klonoff DC, Parkes JL, Kovatchev BP, et al.Investigation of the accuracy of 18 marketedblood glucose monitors. Diabetes Care 2018;41:1681–16885. Grady M, Lamps G, Shemain A, Cameron H,MurrayL. Clinical evaluationofanew, lowerpain,one touch lancing device for people with di-abetes: virtually pain-free testing and improvedcomfort compared to current lancing systems.J Diabetes Sci Technol. 17 July 2019 [Epub aheadof print]. DOI: 10.1177/19322968198566656. Harrison B, Brown D. Accuracy of a bloodglucose monitoring system that recognizes in-sufficient sample blood volume and allows ap-plication of more blood to the same test strip.Expert Rev Med Devices 2020;17:75–827. Miller KM, Beck RW, Bergenstal RM, et al.;T1D Exchange Clinic Network. Evidence of astrong association between frequency of self-monitoring of blood glucose and hemoglobin A1clevels inT1Dexchangeclinic registryparticipants.Diabetes Care 2013;36:2009–20148. Grant RW,Huang ES,Wexler DJ, et al. Patientswho self-monitor blood glucoseand their unusedtesting results. Am J Manag Care 2015;21:e119–e1299. Katz LB, Stewart L, Guthrie B, Cameron H.Patient satisfaction with a new, high accuracy

blood glucose meter that provides personalizedguidance, insight, and encouragement. J Diabe-tes Sci Technol 2020;14:318–32310. Shaw RJ, Yang Q, Barnes A, et al. Self-monitoring diabetes withmultiplemobile healthdevices. J Am Med Inform Assoc 2020;27:667–67611. GelladWF,ZhaoX,ThorpeCT,MorMK,GoodCB, FineMJ. Dual use of Department of VeteransAffairs and Medicare benefits and use of teststrips in veterans with type 2 diabetes mellitus.JAMA Intern Med 2015;175:26–3412. Endocrine Society and ChoosingWisely. Fivethings physicians and patients should question.Accessed 1 November 2020. Available from http://www.choosingwisely.org/societies/endocrine-society/13. Ziegler R, Heidtmann B, Hilgard D, Hofer S,Rosenbauer J, Holl R; DPV-Wiss-Initiative. Fre-quency of SMBG correlates with HbA1c andacute complications in children and adolescentswith type 1 diabetes. Pediatr Diabetes 2011;12:11–1714. Rosenstock J, Davies M, Home PD, Larsen J,Koenen C, Schernthaner G. A randomised,52-week, treat-to-target trial comparing insulindetemir with insulin glargine when administeredas add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia2008;51:408–41615. Garber AJ. Treat-to-target trials: uses, in-terpretation and review of concepts. DiabetesObes Metab 2014;16:193–20516. Farmer A,Wade A, Goyder E, et al. Impact ofself monitoring of blood glucose in the manage-ment of patients with non-insulin treated di-abetes: open parallel group randomised trial.BMJ 2007;335:13217. O’Kane MJ, Bunting B, Copeland M, CoatesVE; ESMON study group. Efficacy of self moni-toring of blood glucose in patients with newlydiagnosed type 2 diabetes (ESMON study): rand-omised controlled trial. BMJ 2008;336:1174–117718. Simon J, Gray A, Clarke P, Wade A, Neil A,Farmer A; Diabetes Glycaemic Education andMonitoring Trial Group. Cost effectiveness of selfmonitoringof bloodglucose inpatientswithnon-insulin treated type 2 diabetes: economic eval-uation of data from the DiGEM trial. BMJ 2008;336:1177–118019. Young LA, Buse JB, Weaver MA, et al.;Monitor Trial Group. Glucose self-monitoringin non-insulin-treated patients with type 2 di-abetes in primary care settings: a randomizedtrial. JAMA Intern Med 2017;177:920–92920. Polonsky WH, Fisher L, Schikman CH, et al.Structured self-monitoring of blood glucose sig-nificantly reducesA1C levels in poorly controlled,noninsulin-treated type 2 diabetes: results fromthe Structured Testing Program study. DiabetesCare 2011;34:262–26721. Malanda UL, Welschen LMC, Riphagen II,Dekker JM, Nijpels G, Bot SDM. Self-monitoringof blood glucose in patients with type 2 diabetesmellitus who are not using insulin. CochraneDatabase Syst Rev 2012;1:CD00506022. Willett LR. ACP Journal Club. Meta-analysis:self-monitoring in non-insulin-treated type 2 di-abetes improved HbA1c by 0.25%. Ann InternMed 2012;156:JC6–JC1223. Mannucci E, Antenore A, Giorgino F, ScaviniM. Effects of structured versus unstructured self-

monitoringofbloodglucoseonglucosecontrol inpatients with non-insulin-treated type 2 diabe-tes: a meta-analysis of randomized controlledtrials. J Diabetes Sci Technol 2018;12:183–18924. Sai S, Urata M, Ogawa I. Evaluation oflinearity and interference effect on SMBG andPOCT devices, showing drastic high values, lowvalues, or error messages. J Diabetes Sci Technol2019;13:734–74325. Ginsberg BH. Factors affecting bloodglucosemonitoring: sources of errors in measurement.J Diabetes Sci Technol 2009;3:903–91326. Juvenile Diabetes Research Foundation Con-tinuousGlucoseMonitoringStudyGroup;TamborlaneWV, Beck RW, Bode BW, et al. Continuousglucose monitoring and intensive treatment oftype 1 diabetes. N Engl J Med 2008;359:1464–147627. Danne T, Nimri R, Battelino T, et al. Interna-tional consensus on use of continuous glucosemonitoring. Diabetes Care 2017;40:1631–164028. Beck RW, Riddlesworth T, Ruedy K, et al.;DIAMOND Study Group. Effect of continuousglucose monitoring on glycemic control in adultswith type 1 diabetes using insulin injections: theDIAMOND randomized clinical trial. JAMA 2017;317:371–37829. Lind M, Polonsky W, Hirsch IB, et al. Con-tinuous glucosemonitoring vs conventional ther-apy for glycemic control in adults with type 1diabetes treated with multiple daily insulin in-jections: the GOLD randomized clinical trial.JAMA 2017;317:379–38730. Cowart K, Updike W, Bullers K. Systematicreviewof randomized controlled trials evaluatingglycemic efficacy and patient satisfaction of in-termittent-scannedcontinuousglucosemonitor-ing in patients with diabetes. Diabetes TechnolTher 2020;22:337–34531. Evans M, Welsh Z, Ells S, Seibold A. Theimpact of flash glucose monitoring on glycaemiccontrolasmeasuredbyHbA1c:ameta-analysisofclinical trials and real-world observational stud-ies. Diabetes Ther 2020;11:83–9532. ReddyM, JugneeN, El LaboudiA, SpanudakisE, Anantharaja S, Oliver N. A randomized con-trolled pilot study of continuous glucose mon-itoring and flash glucose monitoring in peoplewith type 1 diabetes and impaired awareness ofhypoglycaemia. Diabet Med 2018;35:483–49033. Aleppo G, Ruedy KJ, Riddlesworth TD, et al.;REPLACE-BG Study Group. REPLACE-BG: a ran-domized trial comparing continuous glucosemonitoring with and without routine bloodglucosemonitoring in adultswithwell-controlledtype 1 diabetes. Diabetes Care 2017;40:538–54534. U.S. Food and Drug Administration. FDA newsrelease: FDA expands indication for continuousglucose monitoring system, first to replace fin-gerstick testing for diabetes treatment decisions.2016.Accessed1November2020.Available fromhttps://www.fda.gov/newsevents/newsroom/pressannouncements/ucm534056.htm35. U.S. Food and Drug Administration. FDAnews release:. FDA approves first continuousglucose monitoring system for adults not requi-ringbloodsamplecalibration.2017.Accessed1Nov-ember 2020. Available from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm36. Battelino T, Danne T, Bergenstal RM, et al.Clinical targets for continuous glucosemonitoring

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data interpretation: recommendations from theinternationalconsensusontime inrange.DiabetesCare 2019;42:1593–160337. Prahalad P, Addala A, Scheinker D, Hood KK,Maahs DM. CGM initiation soon after type 1diabetes diagnosis results in sustained CGM useand wear time. Diabetes Care 2020;43:e3–e438. Patton SR, Noser AE, Youngkin EM, Majidi S,ClementsMA. Early initiation of diabetes devicesrelates to improved glycemic control in childrenwith recent-onset type 1 diabetes mellitus. Di-abetes Technol Ther 2019;21:379–38439. Addala A, Maahs DM, Scheinker D, ChertowS, Leverenz B, Prahalad P. Uninterrupted con-tinuous glucose monitoring access is associatedwith a decrease in HbA1c in youth with type 1diabetes and public insurance. Pediatr Diabetes2020;21:1301–130940. HermannsN, EhrmannD, SchipferM, KrögerJ, Haak T, Kulzer B. The impact of a structurededucation and treatment programme (FLASH)for people with diabetes using a flash sensor-based glucose monitoring system: results of arandomized controlled trial. Diabetes Res ClinPract 2019;150:111–12141. PintusD,NgSM.FreeStyleLibreflashglucosemonitoring improves patient quality of life mea-sures in children with type 1 diabetes mellitus(T1DM) with appropriate provision of educationand support by healthcare professionals. Diabe-tes Metab Syndr 2019;13:2923–292642. Hilliard ME, Levy W, Anderson BJ, et al.Benefits and barriers of continuous glucosemonitoring in young children with type 1 di-abetes. Diabetes Technol Ther 2019;21:493–49843. Riddlesworth T, Price D, Cohen N, Beck RW.Hypoglycemic event frequency and the effect ofcontinuous glucose monitoring in adults withtype 1 diabetes using multiple daily insulininjections. Diabetes Ther 2017;8:947–95144. Sequeira PA, Montoya L, Ruelas V, et al.Continuous glucose monitoring pilot in low-income type 1 diabetes patients. Diabetes Tech-nol Ther 2013;15:855–85845. Tumminia A, Crimi S, Sciacca L, et al. Efficacyof real-time continuous glucose monitoring onglycaemiccontrol andglucosevariability in type1diabetic patients treated with either insulinpumps or multiple insulin injection therapy:a randomizedcontrolledcrossover trial.DiabetesMetab Res Rev 2015;31:61–6846. Bolinder J, AntunaR,Geelhoed-Duijvestijn P,Kröger J, Weitgasser R. Novel glucose-sensingtechnology and hypoglycaemia in type 1 diabe-tes: a multicentre, non-masked, randomisedcontrolled trial. Lancet 2016;388:2254–226347. Hermanns N, Schumann B, Kulzer B, Haak T.The impact of continuous glucose monitoring onlow interstitial glucose values and low bloodglucose values assessed by point-of-care bloodglucose meters: results of a crossover trial. JDiabetes Sci Technol 2014;8:516–52248. van Beers CAJ, DeVries JH, Kleijer SJ, et al.Continuous glucosemonitoring for patients withtype 1 diabetes and impaired awareness ofhypoglycaemia (IN CONTROL): a randomised,open-label, crossover trial. Lancet Diabetes En-docrinol 2016;4:893–90249. Battelino T, Conget I, Olsen B, et al.; SWITCHStudy Group. The use and efficacy of continuousglucose monitoring in type 1 diabetes treated

with insulin pump therapy: a randomised con-trolled trial. Diabetologia 2012;55:3155–316250. Deiss D, Bolinder J, Riveline J-P, et al. Im-proved glycemic control in poorly controlledpatients with type 1 diabetes using real-timecontinuous glucose monitoring. Diabetes Care2006;29:2730–273251. O’Connell MA, Donath S, O’Neal DN, et al.Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a rand-omised controlled trial. Diabetologia 2009;52:1250–125752. Battelino T, Phillip M, Bratina N, Nimri R,Oskarsson P, Bolinder J. Effect of continuousglucose monitoring on hypoglycemia in type 1diabetes. Diabetes Care 2011;34:795–80053. Heinemann L, Freckmann G, Ehrmann D,et al. Real-time continuous glucose monitoringin adults with type 1 diabetes and impairedhypoglycaemia awareness or severe hypoglycae-mia treated with multiple daily insulin injections(HypoDE): a multicentre, randomised controlledtrial. Lancet 2018;391:1367–137754. Juvenile Diabetes Research FoundationContinuous Glucose Monitoring Study Group;Beck RW, Hirsch IB, Laffel L, et al. The effect ofcontinuous glucose monitoring in well-controlledtype 1 diabetes. Diabetes Care 2009;32:1378–138355. Wong JC, Foster NC, Maahs DM, et al.; T1DExchange Clinic Network. Real-time continuousglucose monitoring among participants in theT1DExchange clinic registry. Diabetes Care 2014;37:2702–270956. Juvenile Diabetes Research Foundation Con-tinuous Glucose Monitoring Study Group; BeckRW, Buckingham B, Miller K, et al. Factors pre-dictive of use and of benefit from continuousglucose monitoring in type 1 diabetes. DiabetesCare 2009;32:1947–195357. Juvenile Diabetes Research Foundation Con-tinuous Glucose Monitoring Study Group. Effec-tiveness of continuous glucose monitoring in aclinical care environment: evidence from theJuvenile Diabetes Research Foundation contin-uous glucose monitoring (JDRF-CGM) trial. Di-abetes Care 2010;33:17–2258. ChaseHP, Beck RW, XingD, et al. Continuousglucosemonitoring in youthwith type1diabetes:12-month follow-up of the Juvenile DiabetesResearch Foundation continuous glucose mon-itoring randomized trial. Diabetes Technol Ther2010;12:507–51559. Pickup JC, Freeman SC, Sutton AJ. Glycaemiccontrol in type 1 diabetes during real timecontinuous glucose monitoring compared withself monitoring of blood glucose: meta-analysisof randomised controlled trials using individualpatient data. BMJ 2011;343:d380560. Mauras N, Beck R, Xing D, et al.; DiabetesResearch in Children Network (DirecNet) StudyGroup. A randomized clinical trial to assess theefficacy and safety of real-time continuous glu-cose monitoring in the management of type 1diabetes in young children aged 4 to,10 years.Diabetes Care 2012;35:204–21061. Jeha GS, Karaviti LP, Anderson B, et al.Continuous glucose monitoring and the realityof metabolic control in preschool children withtype 1 diabetes. Diabetes Care 2004;27:2881–288662. Gandrud LM, Xing D, Kollman C, et al. TheMedtronic Minimed Gold continuous glucose

monitoring system: an effective means to dis-cover hypo- and hyperglycemia in children under7 years of age. Diabetes Technol Ther 2007;9:307–31663. Tsalikian E, Fox L, Weinzimer S, et al.; Di-abetes Research in Children Network StudyGroup. Feasibility of prolonged continuous glu-cosemonitoring in toddlerswith type 1 diabetes.Pediatr Diabetes 2012;13:301–30764. Foster NC, Miller KM, Tamborlane WV,Bergenstal RM, Beck RW; T1D Exchange ClinicNetwork. Continuous glucose monitoring in pa-tients with type 1 diabetes using insulin injec-tions. Diabetes Care 2016;39:e81–e8265. Zabeen B, Craig ME, Virk SA, et al. Insulinpump therapy is associated with lower rates ofretinopathy and peripheral nerve abnormality.PLoS One 2016;11:e015303366. Sundberg F, Barnard K, Cato A, et al. ISPADGuidelines. Managing diabetes in preschool chil-dren. Pediatr Diabetes 2017;18:499–51767. Yoo HJ, An HG, Park SY, et al. Use of a realtime continuous glucose monitoring system as amotivational device for poorly controlled type 2diabetes. Diabetes Res Clin Pract 2008;82:73–7968. Ehrhardt NM, Chellappa M, Walker MS,Fonda SJ, Vigersky RA. The effect of real-timecontinuous glucose monitoring on glycemic con-trol in patients with type 2 diabetes mellitus. JDiabetes Sci Technol 2011;5:668–67569. Beck RW, Riddlesworth TD, Ruedy K, et al.;DIAMOND Study Group. Continuous glucosemonitoring versus usual care in patients withtype 2 diabetes receiving multiple daily insulininjections: a randomized trial. Ann Intern Med2017;167:365–37470. Davis TME, Dwyer P, England M, Fegan PG,Davis WA. Efficacy of intermittently scannedcontinuous glucosemonitoring in the preventionof recurrent severe hypoglycemia. DiabetesTechnol Ther 2020;22:367–37371. Haak T, Hanaire H, Ajjan R, Hermanns N,Riveline J-P, Rayman G. Flash glucose-sensingtechnology as a replacement for blood glucosemonitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Ther2017;8:55–7372. Yaron M, Roitman E, Aharon-Hananel G,et al. Effect of flash glucose monitoring technol-ogy on glycemic control and treatment satisfac-tion in patients with type 2 diabetes. DiabetesCare 2019;42:1178–118473. Paris I, Henry C, Pirard F, Gérard A-C, ColinIM. The new FreeStyle Libre flash glucose mon-itoring system improves the glycaemic controlin a cohort of people with type 1 diabetesfollowed in real-life conditions over a periodof one year. Endocrinol Diabetes Metab 2018;1:e0002374. Vergier J, Samper M, Dalla-Vale F, et al.Evaluationofflash glucosemonitoring after long-term use: a pediatric survey. Prim Care Diabetes2019;13:63–7075. Landau Z, Abiri S, GruberN, et al. Use of flashglucose-sensing technology (FreeStyle Libre) inyouth with type 1 diabetes: AWeSoMe studygroup real-life observational experience. ActaDiabetol 2018;55:1303–131076. Deja G, Kłeczek M, Chumięcki M, Strzała-Kłeczek A, Deja R, Jarosz-Chobot P. The useful-ness of the FlashStyle Libre system in glycemic

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control in children with type 1 diabetes duringsummer camp. Pediatr Endocrinol DiabetesMetab 2018;24:11–1977. Kröger J, Fasching P, Hanaire H. Three Eu-ropean retrospective real-world chart reviewstudies to determine the effectiveness of flashglucose monitoring on HbA1c in adults withtype 2 diabetes. Diabetes Ther 2020;11:279–29178. Messaaoui A, Tenoutasse S, Crenier L. Flashglucose monitoring accepted in daily life ofchildren and adolescents with type 1 diabetesand reduction of severe hypoglycemia in real-life use. Diabetes Technol Ther 2019;21:329–33579. Charleer S, De Block C, Van Huffel L, et al.Quality of life and glucose control after 1 year ofnationwide reimbursement of intermittentlyscanned continuous glucosemonitoring in adultsliving with type 1 diabetes (FUTURE): a prospec-tive observational real-world cohort study. Di-abetes Care 2020;43:389–39780. Norwegian Institute of Public Health. Free-Style Libre flash glucose self-monitoring system:a single-technology assessment. 2017. Accessed1 November 2020. Available from http://www.fhi.no/en/publ/2017/freestyle-libre-systemet-for-egenmaling-av-blodsukker-en-hurtigmetodevurder/81. Palylyk-Colwell E, Ford C. Flash glucosemonitoring system for diabetes. In CADTH Issuesin Emerging Health Technologies. Ottawa, ON,Canadian Agency for Drugs and Technologies inHealth, 2016. Accessed 1 November 2020. Avail-able from http://www.ncbi.nlm.nih.gov/books/NBK476439/82. Leelarathna L, Wilmot EG. Flash forward:a reviewof flash glucosemonitoring. DiabetMed2018;35:472–48283. Castellana M, Parisi C, Di Molfetta S, et al.Efficacy and safety of flash glucose monitoring inpatients with type 1 and type 2 diabetes: a sys-tematic review and meta-analysis. BMJ OpenDiabetes Res Care 2020;8:e00109284. Ang E, Lee ZX, Moore S, Nana M. Flashglucose monitoring (FGM): a clinical review onglycaemicoutcomesand impact onqualityof life.J Diabetes Complications 2020;34:10755985. Al Hayek AA, Robert AA, Al Dawish MA.Acceptability of the FreeStyle Libre flash glucosemonitoring system: the experience of young pa-tients with type 1 diabetes. Clin Med InsightsEndocrinol Diabetes 2020;13:117955142091012286. Babaya N, Noso S, Hiromine Y, et al. Flashglucose monitoring in type 1 diabetes: a com-parison with self-monitoring blood glucose. JDiabetes Investig 2020;11:1222–122987. Halbron M, Bourron O, Andreelli F, et al.Insulin pump combined with flash glucose mon-itoring: a therapeutic option to improve glycemiccontrol in severely nonadherent patients withtype 1 diabetes. Diabetes Technol Ther 2019;21:409–41288. Feig DS, Donovan LE, Corcoy R, et al.; CON-CEPTT Collaborative Group. Continuous glucosemonitoring in pregnant women with type 1 di-abetes (CONCEPTT): a multicentre internationalrandomised controlled trial. Lancet 2017;390:2347–235989. Kristensen K, Ögge LE, Sengpiel V, et al.Continuous glucose monitoring in pregnantwomen with type 1 diabetes: an observationalcohort study of 186 pregnancies. Diabetologia2019;62:1143–1153

90. Law GR, Gilthorpe MS, Secher AL, et al.Translating HbA1c measurements into estimatedaverage glucose values in pregnant women withdiabetes. Diabetologia 2017;60:618–62491. Secher AL, Ringholm L, Andersen HU, DammP, Mathiesen ER. The effect of real-time contin-uous glucose monitoring in pregnant womenwith diabetes: a randomized controlled trial.Diabetes Care 2013;36:1877–188392. Wei Q, Sun Z, Yang Y, Yu H, Ding H, Wang S.Effect of a CGMS and SMBG on maternal andneonatal outcomes in gestational diabetes mel-litus: a randomized controlled trial. Sci Rep 2016;6:1992093. Ajjan RA, Jackson N, Thomson SA. Reduc-tion in HbA1c using professional flash glucosemonitoring in insulin-treated type 2 diabetespatients managed in primary and secondarycare settings: a pilot, multicentre, randomisedcontrolled trial. Diab Vasc Dis Res 2019;16:385–39594. Wada E, Onoue T, Kobayashi T, et al. Flashglucose monitoring helps achieve better glyce-mic control than conventional self-monitoring ofblood glucose in non-insulin-treated type 2 di-abetes: a randomized controlled trial. BMJ OpenDiabetes Res Care 2020;8:e00111595. Pleus S, Ulbrich S, Zschornack E, Kamann S,Haug C, Freckmann G. Documentation of skin-related issues associated with continuous glu-cose monitoring use in the scientific literature.Diabetes Technol Ther 2019;21:538–54596. Herman A, deMontjoye L, BaeckM. Adversecutaneous reaction to diabetic glucose sensorsand insulin pumps: irritant contact dermatitis orallergic contact dermatitis? Contact Dermat2020;83:25–3097. Rigo RS, Levin LE, Belsito DV, Garzon MC,Gandica R, Williams KM. Cutaneous reactions tocontinuous glucose monitoring and continuoussubcutaneous insulin infusion devices in type 1diabetes mellitus. J Diabetes Sci Technol. 9 May2020 [Epub ahead of print]. DOI: 10.1177/193229682091889498. Kamann S, Aerts O, Heinemann L. Furtherevidence of severe allergic contact dermatitisfrom isobornyl acrylate while using a continuousglucose monitoring system. J Diabetes Sci Tech-nol 2018;12:630–63399. Aerts O, Herman A, Bruze M, Goossens A,Mowitz M FreeStyle Libre: contact irritationversus contact allergy. Lancet 2017;390:1644100. Herman A, Aerts O, Baeck M, et al. Allergiccontact dermatitis caused by isobornyl acrylatein Freestyle� Libre, a newly introduced glucosesensor. Contact Dermat 2017;77:367–373101. Hyry HSI, Liippo JP, Virtanen HM. Allergiccontact dermatitis caused by glucose sensors intype 1 diabetes patients. Contact Dermat 2019;81:161–166102. Asarani NAM, Reynolds AN, Boucher SE, deBock M, Wheeler BJ. Cutaneous complicationswith continuous or flash glucose monitoringuse: systematic review of trials and observa-tional studies. J Diabetes Sci Technol 2020;14:328–337103. Lombardo F, Salzano G, Crisafulli G, et al.Allergic contact dermatitis in pediatric patientswith type1diabetes: anemerging issue.DiabetesRes Clin Pract 2020;162:108089104. Oppel E, Kamann S, Heinemann L, ReichlF-X, Högg C. The implanted glucose monitoring

system Eversense: an alternative for diabetespatients with isobornyl acrylate allergy. ContactDermat 2020;82:101–104105. FreckmannG, Buck S,WaldenmaierD, et al.Skin reaction report form: development anddesign of a standardized report form for skinreactions due to medical devices for diabetesmanagement. J Diabetes Sci Technol. 22 March2020 [Epub ahead of print]. DOI: 10.1177/1932296820911105106. Deiss D, Irace C, Carlson G, Tweden KS,Kaufman FR. Real-world safety of an implantablecontinuousglucose sensorovermultiple cyclesofuse: a post-market registry study. Diabetes Tech-nol Ther 2020;22:48–52107. Sanchez P, Ghosh-Dastidar S, Tweden KS,Kaufman FR. Real-world data from the first U.S.commercial users of an implantable continuousglucose sensor. Diabetes Technol Ther 2019;21:677–681108. Lasalvia P, Barahona-Correa JE, Romero-Alvernia DM, et al. Pen devices for insulin self-administration compared with needle and vial:systematic review of the literature and meta-analysis. J Diabetes Sci Technol 2016;10:959–966109. Hanas R, de Beaufort C, Hoey H, AndersonB. Insulin delivery by injection in children andadolescents with diabetes. Pediatr Diabetes2011;12:518–526110. Pfützner A, Schipper C, Niemeyer M, et al.Comparison of patient preference for two insulininjection pen devices in relation to patientdexterity skills. J Diabetes Sci Technol 2012;6:910–916111. Williams AS, Schnarrenberger PA. A com-parison of dosing accuracy: visually impaired andsighted people using insulin pens. J Diabetes SciTechnol 2010;4:514–521112. Reinauer KM, Joksch G, Renn W, EggsteinM. Insulin pens in elderly diabetic patients.Diabetes Care 1990;13:1136–1137113. Thomas DR, Fischer RG, Nicholas WC,Beghe C, Hatten KW, Thomas JN. Disposableinsulin syringe reuse and aseptic practices indiabeticpatients. JGenInternMed1989;4:97–100114. Gomez-Peralta F, Abreu C, Gomez-RodriguezS, et al. Efficacy of Insulclock in patients with poorlycontrolled type 1 diabetes mellitus: a pilot, ran-domized clinical trial. Diabetes Technol Ther 2020;22:686–690115. Bailey TS, Stone JY. A novel pen-basedBluetooth-enabled insulin delivery systemwith insulin dose tracking and advice. ExpertOpin Drug Deliv 2017;14:697–703116. EilandL,McLarneyM,ThangaveluT,DrincicA App-based insulin calculators: current andfuture state. Curr Diab Rep 2018;18:123117. HuckvaleK, Adomaviciute S, Prieto JT, LeowMK-S, Car J. Smartphone apps for calculatinginsulin dose: a systematic assessment. BMCMed2015;13:106118. Breton MD, Patek SD, Lv D, et al. Contin-uous glucose monitoring and insulin informedadvisory system with automated titration anddosing of insulin reduces glucose variability intype 1 diabetes mellitus. Diabetes Technol Ther2018;20:531–540119. 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;393:1138–1148

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120. Yeh H-C, Brown TT, Maruthur N, et al.Comparative effectiveness and safety of meth-odsof insulin delivery andglucosemonitoring fordiabetesmellitus: a systematic review andmeta-analysis. Ann Intern Med 2012;157:336–347121. Pickup JC. The evidence base for diabetestechnology: appropriate and inappropriatemeta-analysis. J Diabetes Sci Technol 2013;7:1567–1574122. 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;15:564–572123. LinMH, Connor CG, Ruedy KJ, et al.; PediatricDiabetes Consortium. Race, socioeconomic status,and treatment center are associated with insulinpump therapy in youth in the first year followingdiagnosis of type 1 diabetes. Diabetes Technol Ther2013;15:929–934124. 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;135:424–434125. 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;41:1017–1024126. Ramchandani N, Ten S, Anhalt H, et al.Insulin pump therapy from the time of diagnosisof type1diabetes.DiabetesTechnol Ther2006;8:663–670127. BerghaeuserMA, Kapellen T, Heidtmann B,Haberland H, Klinkert C, Holl RW; German work-ing group for insulin pump treatment in paedi-atric patients. Continuous subcutaneous insulininfusion in toddlers starting at diagnosis of type 1diabetes mellitus. A multicenter analysis of104 patients from 63 centres in Germany andAustria. Pediatr Diabetes 2008;9:590–595128. Peters AL, Ahmann AJ, Battelino T, et al.Diabetes technology-continuous subcutaneousinsulin infusion therapy and continuous glucosemonitoring in adults: an Endocrine Society clin-ical practice guideline. J Clin Endocrinol Metab2016;101:3922–3937129. Gill M, Chhabra H, Shah M, Zhu C,Grunberger G. C-peptide and beta-cell autoan-tibody testing prior to initiating continuous sub-cutaneous insulin infusion pump therapy did notimprove utilization ormedical costs among olderadults with diabetesmellitus. Endocr Pract 2018;24:634–645130. Vigersky RA, Huang S, Cordero TL, et al.;OpT2mise Study Group. Improved HbA1c, totaldaily insulin dose, and treatment satisfactionwith insulin pump therapy compared tomultipledaily insulin injections in patients with type 2diabetes irrespective of baseline C-peptide lev-els. Endocr Pract 2018;24:446–452131. Wheeler BJ, Heels K, Donaghue KC, ReithDM, Ambler GR. Insulin pump-associated ad-verse events in children and adolescentsdaprospective study. Diabetes Technol Ther2014;16:558–562132. Kordonouri O, Lauterborn R, Deiss D. Lip-ohypertrophy in young patients with type 1diabetes. Diabetes Care 2002;25:634133. Kordonouri O, HartmannR, Remus K, BläsigS, SadeghianE, DanneT. Benefit of supplementary

fat plus protein counting as compared with con-ventional carbohydrate counting for insulin boluscalculation in childrenwith pump therapy. PediatrDiabetes 2012;13:540–544134. Guinn TS, Bailey GJ, Mecklenburg RS. Fac-tors related to discontinuation of continuoussubcutaneous insulin-infusion therapy. DiabetesCare 1988;11:46–51135. Wong JC, Boyle C, DiMeglio LA, et al.; T1DExchange Clinic Network. Evaluation of pumpdiscontinuationandassociated factors in theT1DExchange clinic registry. J Diabetes Sci Technol2017;11:224–232136. Wong JC, Dolan LM, Yang TT, Hood KK.Insulin pump use and glycemic control in ado-lescents with type 1 diabetes: predictors ofchange in method of insulin delivery acrosstwo years. Pediatr Diabetes 2015;16:592–599137. Plotnick LP,ClarkLM,Brancati FL, ErlingerT.Safety and effectiveness of insulin pump therapyin children and adolescents with type 1 diabetes.Diabetes Care 2003;26:1142–1146138. Redondo MJ, Connor CG, Ruedy KJ, et al.;Pediatric Diabetes Consortium. Pediatric Diabe-tes Consortium Type 1 Diabetes New Onset(NeOn) Study: factors associated with HbA1clevels one year after diagnosis. Pediatr Diabetes2014;15:294–302139. Doyle EA, Weinzimer SA, Steffen AT, AhernJAH, Vincent M, Tamborlane WVA. A random-ized, prospective trial comparing the efficacy ofcontinuous subcutaneous insulin infusion withmultiple daily injections using insulin glargine.Diabetes Care 2004;27:1554–1558140. Alemzadeh R, Ellis JN, Holzum MK, PartonEA, Wyatt DT. Beneficial effects of continuoussubcutaneous insulin infusion and flexible mul-tiple daily insulin regimen using insulin glarginein type 1 diabetes. Pediatrics 2004;114:e91–e95141. Sherr JL, Hermann JM, Campbell F, et al.;T1D Exchange Clinic Network, the DPV Initiative,and the National Paediatric Diabetes Audit andthe Royal College of Paediatrics and Child Healthregistries.Useof insulinpumptherapy inchildrenand adolescents with type 1 diabetes and itsimpact on metabolic control: comparison ofresults from three large, transatlantic paediatricregistries. Diabetologia 2016;59:87–91142. Jeitler K, Horvath K, Berghold A, et al.Continuous subcutaneous insulin infusion versusmultiple daily insulin injections in patients withdiabetes mellitus: systematic review and meta-analysis. Diabetologia 2008;51:941–951143. Karges B, Schwandt A, Heidtmann B, et al.Association of insulin pump therapy vs insulininjection therapy with severe hypoglycemia, ke