1、7. Diabetes Technology:Standards of Medical Care inDiabetes2022Diabetes Care 2022;45(Suppl. 1):S97S112 | https:/doi.org/10.2337/dc22-S007American Diabetes AssociationProfessional Practice Committee*The American Diabetes Association (ADA) “Standards of Medical Care in Dia-betes” includes the ADAs cur
2、rent clinical practice recommendations and isintended to provide the components of diabetes care, general treatment goalsand guidelines, and tools to evaluate quality of care. Members of the ADA Profes-sional Practice Committee, a multidisciplinary expert committee (https:/doi.org/10.2337/dc22-SPPC)
3、, are responsible for updating the Standards of Care annually,or more frequently as warranted. For a detailed description of ADA standards,statements, and reports, as well as the evidence-grading system for ADAs clinicalpractice recommendations, please refer to the Standards of Care Introduction(htt
4、ps:/doi.org/10.2337/dc22-SINT). Readers who wish to comment on the Stand-ards of Care are invited to doso at professional.diabetes.org/SOC.Diabetes technology is the term used to describe the hardware, devices, and soft-ware that people with diabetes use to help manage their condition, from lifestyl
5、eto blood glucose levels. Historically, diabetes technology has been divided into twomain categories: insulin administered by syringe, pen, or pump (also called continu-ous subcutaneous insulin infusion CSII), and blood glucose as assessed by bloodglucose monitoring (BGM) or continuous glucose monit
6、oring (CGM). More recently,diabetes technology has expanded to include hybrid devices that both monitor glu-cose 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 an
7、d 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 imple-mentation.GENERAL DEVICE PRINCIPLESRecommendations7.1The type(s) and selection of devices should be i
8、ndividualized based ona persons specific needs, desires, skill level, and availability of devices.In the setting of an individual whose diabetes is partially or whollymanaged by someone else (e.g., a young child or a person with cogni-tive impairment), the caregivers skills and desires are integral
9、to thedecision-making process. E7.2When prescribing a device, ensure that people with diabetes/caregiversreceive initial and ongoing education and training, either in-person orremotely, and regular evaluation of technique, results, and their ability*A complete list of members of the AmericanDiabetes
10、AssociationProfessionalPracticeCommittee can be found at https:/doi.org/10.2337/dc22-SPPC.Suggested citation: American Diabetes Asso-ciation Professional Practice Committee. 7. Dia-betes technology: Standards of Medical CareinDiabetes2022.DiabetesCare2022;45(Suppl. 1):S97S112 2021 by the American Di
11、abetes Association.Readers may use this article as long as thework is properly cited, the use is educationaland not for profit, and the work is not altered.Moreinformationisavailableathttps:/diabetesjournals.org/journals/pages/license.7. DIABETES TECHNOLOGYDiabetes Care Volume 45, Supplement 1, Janu
12、ary 2022S97Downloaded from http:/diabetesjournals.org/care/article-pdf/45/Supplement_1/S97/637511/dc22s007.pdf by guest on 10 July 2022to use data, including upload-ing/sharing data (if applica-ble), to adjust therapy. C7.3People who have been usingcontinuous glucose monitoring,continuous subcutaneo
13、us insu-lin infusion, and/or automatedinsulin delivery for diabetesmanagement should have con-tinuedaccessacrossthird-party payers. E7.4Students must be supportedat school in the use of diabe-tes technology including con-tinuous subcutaneous insulininfusion,connectedinsulinpens, and automated insuli
14、ndeliverysystemsaspre-scribed by their diabetes careteam. E7.5Initiation of continuous glu-cose monitoring, continuoussubcutaneousinsulininfu-sion, and/or automated insu-lindeliveryearlyinthetreatment of diabetes can bebeneficialdependingonapersons/caregivers needs andpreferences. CTechnology is rap
15、idly changing, butthere is no “one-size-fits-all” approachto technology use in people with diabe-tes. Insurance coverage can lag behinddevice availability, patient interest indevices and willingness to change canvary, and providers may have troublekeeping up with newly released technol-ogy. Not-for-
16、profit websites can helpproviders and patients make decisionsas to the initial choice of devices. Othersources, including health care providersand device manufacturers, can helppeople troubleshoot when difficultiesarise.Education and TrainingIn general, no device used in diabetesmanagement works opt
17、imally withouteducation,training,andfollow-up.Therearemultipleresourcesforonline tutorials and training videos aswell as written material on the use ofdevices. Patients vary in terms of com-fort level with technology, and someprefer in-person training and support.Patients with more education regard-
18、ing device use have better outcomes(1); therefore, the need for additionaleducationshouldbeperiodicallyassessed, particularly if outcomes arenot being met.Use in SchoolsInstructions for device use should beoutlined in the students diabetes medi-cal management plan (DMMP). A back-up plan should be in
19、cluded in theDMMP for potential device failure (e.g.,BGM and/or injected insulin). Schoolnurses and designees should completetraining to stay up to date on diabetestechnologies prescribed for use in theschool setting. Updated resources tosupport diabetes care at school, includ-ing training materials
20、 and a DMMP tem-plate, can be found online at www.diabetes.org/safeatschool.Initiation of Device UseUse of CGM devices should be consideredfrom the outset of the diagnosis of diabe-tes that requires insulin management(2,3). This allows for close tracking of glu-cose levels with adjustments of insuli
21、ndosing and lifestyle modifications andremoves the burden of frequent BGM. Inappropriate individuals, early use of auto-mated insulin delivery (AID) systems orcontinuous subcutaneous insulin infusion(CSII) may be considered. Interruption ofaccess to CGM is associated with a wors-ening of outcomes (4
22、); therefore, it isimportant for individuals on CGM to haveconsistent access to devices.BLOOD GLUCOSE MONITORINGRecommendations7.6People with diabetes shouldbe provided with blood glu-cosemonitoringdevicesasindicated by their circumstan-ces, preferences, and treat-ment. People using continuousglucos
23、emonitoringdevicesmust have access to blood glu-cose monitoring at all times. A7.7People who are on insulinusing blood glucose monitor-ing should be encouraged tocheck when appropriate basedon their insulin regimen. Thismay include checking whenfasting, prior to meals andsnacks, at bedtime, prior to
24、exercise,whenlowbloodglucoseissuspected,aftertreating low blood glucose lev-els until they are normoglyce-mic, and prior to and whileperforming critical tasks suchas driving. B7.8Providers should be aware ofthedifferencesinaccuracyamong blood glucose metersonly U.S. Food and Drug Admin-istrationappr
25、oved meters withprovenaccuracyshouldbeused, with unexpired strips pur-chased from a pharmacy orlicensed distributor. E7.9Although blood glucose moni-toring in individuals on nonin-sulintherapieshasnotconsistentlyshownclinicallysignificant reductions in A1C, itmay be helpful when alteringdiet, physic
26、al activity, and/ormedications (particularly medi-cations that can cause hypogly-cemia) in conjunction with atreatmentadjustmentpro-gram. E7.10Health care providers shouldbe aware of medications andother factors, such as high-dose vitamin C and hypoxemia,that can interfere with glucosemeter accuracy
27、 and provideclinical management as indi-cated. EMajor clinical trials of insulin-treatedpatients have included BGM as part ofmultifactorial interventions to demon-strate the benefit of intensive glycemiccontrol on diabetes complications (5).BGM is thus an integral component ofeffective therapy of pa
28、tients taking insu-lin. In recent years, CGM has emergedas a method for the assessment of glu-cose levels (discussed below). Glucosemonitoring allows patients to evaluatetheir individual response to therapyand assess whether glycemic targetsare being safely achieved. Integratingresults into diabetes
29、 management canbe a useful tool for guiding medicalnutrition therapy and physical activity,preventing hypoglycemia, or adjustingmedications (particularly prandial insulindoses). The patients specific needs andgoals should dictate BGM frequencyand timing or the consideration of CGMuse. As recommended
30、 by the deviceS98Diabetes TechnologyDiabetes Care Volume 45, Supplement 1, January 2022Downloaded from http:/diabetesjournals.org/care/article-pdf/45/Supplement_1/S97/637511/dc22s007.pdf by guest on 10 July 2022manufacturers and the U.S. Food andDrugAdministration(FDA),patientsusing CGM must have ac
31、cess to BGMtesting for multiple reasons, includingwhenever there is suspicion that theCGM is inaccurate, while waiting forwarm-up, for calibration (some sensors)or if a warning message appears, and inany clinical setting where glucose levelsare changing rapidly (2 mg/dL/min),whichcouldcauseadiscrepa
32、ncybetween CGM and blood glucose.Meter StandardsGlucose meters meeting FDA guidancefor meter accuracy provide the mostreliable data for diabetes management.There are several current standards foraccuracy of blood glucose monitors, butthe two most used are those of theInternational Organization for S
33、tandardi-zation (ISO) (ISO 15197:2013) and theFDA. The current ISO and FDA standardsare compared in Table 7.1. In Europe,currently marketed monitors must meetcurrent ISO standards. In the U.S., cur-rently marketed monitors must meetthe standard under which they wereapproved, which may not be the cur
34、-rent standard. Moreover, the monitor-ing of current accuracy is left to themanufacturer and not routinely checkedby an independent source.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 ofwide
35、ly used BGM systems (6,7). The Dia-betes Technology Society Blood GlucoseMonitoring System Surveillance Programprovides information on the performanceof devices used for BGM (www.diabetestechnology.org/surveillance/). In oneanalysis, only 6 of the top 18 glucosemeters met the accuracy standard (8).T
36、here are single-meter studies in whichbenefits have been found with individualmeter systems, but few studies havecompared meters in a head-to-head man-ner. Certain meter system characteristics,such as the use of lancing devices thatare less painful (9) and the ability to reap-ply blood to a strip wi
37、th an insufficientinitial sample, may also be beneficial topatients (10) and may make BGM lessburdensome for patients to perform.Counterfeit StripsPatients should be advised against pur-chasing or reselling preowned or second-hand test strips, as these may give incor-rect results. Only unopened and
38、unex-pired vials of glucose test strips shouldbe used to ensure BGM accuracy.Optimizing Blood GlucoseMonitoring Device UseOptimal use of BGM devices requiresproper review and interpretation of data,by both the patient and the provider, toensure that data are used in an effectiveand timely manner. In
39、 patients with type1 diabetes, there is a correlation betweengreater BGM frequency and lower A1C(11). Among patients who check theirblood glucose at least once daily, manyreport taking no action when results arehigh or low (12). Some meters now pro-vide advice to the user in real time whenmonitoring
40、 glucose levels (13), whereasothers can be used as a part of inte-grated health platforms (14). Patientsshould be taught how to use BGM datato adjust food intake, exercise, or phar-macologic therapy to achieve specificgoals.Theongoingneedforandfrequency of BGM should be reevaluatedat each routine vi
41、sit to ensure its effec-tive use (12,15,16).Patients on Intensive Insulin RegimensBGM 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 MDI orinsulin pump therapy)
42、 should be encour-aged to assess glucose levels using BGM(and/or CGM) prior to meals and snacks,at bedtime, occasionally postprandially,prior to exercise, when they suspect lowblood glucose, after treating low bloodglucose until they are normoglycemic,and prior to and while performing criticaltasks
43、such as driving. For many patientsusing BGM this requires checking up to610 times daily, although individualneeds may vary. A database study ofalmost 27,000 children and adolescentswith type 1 diabetes showed that, afteradjustment for multiple confounders,increased daily frequency of BGM wassignific
44、antly associated with lower A1C(?0.2% per additional check per day)and with fewer acute complications (17).Patients Using Basal Insulin and/or OralAgentsThe evidence is insufficient regardingwhen to prescribe BGM and how oftenmonitoring is needed for insulin-treatedpatients who do not use intensive
45、insulinregimens, such as those with type 2 dia-betes using basal insulin with or withoutoral agents. However, for patients usingbasal insulin, assessing fasting glucosewith BGM to inform dose adjustments toachieve blood glucose targets results inlower A1C (18,19).Table 7.1Comparison of ISO 15197:201
46、3 and FDA blood glucose meter accuracy standardsSettingFDA (224,225)ISO 15197:2013 (226)Home use95% within 15% for all BG in the usable BG range99% within 20% for all BG in the usable BG range95% within 15% for BG $100 mg/dL95% within 15 mg/dL for BG 100 mg/dL99% in A or B region of consensus error
47、gridHospital use95% within 12% for BG $75 mg/dL95% within 12 mg/dL for BG 75 mg/dL98% within 15% for BG $75 mg/dL98% within 15 mg/dL for BG 75 mg/dLBG, blood glucose; FDA, U.S. Food and Drug Administration; ISO, International Organization for Standardization. To convert mg/dL to mmol/L,see The range
48、 of blood glucose values for which the meter has been proven accurate andwill 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 (228).care.diabetesjou
49、rnals.orgDiabetes TechnologyS99Downloaded from http:/diabetesjournals.org/care/article-pdf/45/Supplement_1/S97/637511/dc22s007.pdf by guest on 10 July 2022In people with type 2 diabetes notusing insulin, routine glucose monitor-ing may be of limited additional clinicalbenefit. By itself, even when combinedwith education, it has showed limitedimprovementinoutcomes(2023).However, for some individuals, glucosemonitoring can provide insight into theimpact of diet, physical activity, andmedicationmanagementonglucoselevels. Glucose monitoring may also beuseful in assessing hypoglycemia, glu-cose le
