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Standards of Care in Diabetes 2023
Standards of Care in Diabetes 2023
7. DIABETES TECHNOLOGY
cludes the ADA’s current clinical practice recommendations and is intended to
provide the components of diabetes care, general treatment goals and guide-
lines, and tools to evaluate quality of care. Members of the ADA Professional
Practice Committee, a multidisciplinary expert committee, are responsible for up-
dating the Standards of Care annually, or more frequently as warranted. For a de-
tailed description of ADA standards, statements, and reports, as well as the
evidence-grading system for ADA’s clinical practice recommendations and a full
list of Professional Practice Committee members, please refer to Introduction
and Methodology. Readers who wish to comment on the Standards of Care are
invited to do so 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 assist with self-management, ranging from
lifestyle modifications to glucose monitoring and therapy adjustments. Historically,
diabetes technology has been divided into two main categories: insulin adminis-
tered by syringe, pen, or pump (also called continuous subcutaneous insulin infu-
sion), and glucose as assessed by blood glucose monitoring (BGM) or continuous
glucose monitoring (CGM). Diabetes technology has expanded to include automated
insulin delivery (AID) systems, where CGM-informed algorithms modulate insulin de-
livery, as well as diabetes self-management support software serving as medical devi-
ces. Diabetes technology, when coupled with education, follow-up, and support, can
improve the lives and health of people with diabetes; however, the complexity and
rapid evolution of the diabetes technology landscape can also be a barrier to imple-
mentation for both people with diabetes and the health care team.
Recommendations
7.1 The type(s) and selection of devices should be individualized based on a Disclosure information for each author is
available at https://doi.org/10.2337/dc23-SDIS.
person’s specific needs, preferences, and skill level. In the setting of an
individual whose diabetes is partially or wholly managed by someone else Suggested citation: ElSayed NA, Aleppo G,
Aroda VR, et al., American Diabetes Association.
(e.g., a young child or a person with cognitive impairment or dexterity, psy- 7. Diabetes technology: Standards of Care in
chosocial, and/or physical limitations), the caregiver’s skills and preferences Diabetes—2023. Diabetes Care 2023;46(Suppl. 1):
are integral to the decision-making process. E S111–S127
7.2 When prescribing a device, ensure that people with diabetes/caregivers © 2022 by the American Diabetes Association.
receive initial and ongoing education and training, either in-person or Readers may use this article as long as the
remotely, and ongoing evaluation of technique, results, and their ability work is properly cited, the use is educational
to utilize data, including uploading/sharing data (if applicable), to moni- and not for profit, and the work is not altered.
tor and adjust therapy. C More information is available at https://www.
diabetesjournals.org/journals/pages/license.
S112 Diabetes Technology Diabetes Care Volume 46, Supplement 1, January 2023
7.3 People with diabetes who have assessed, particularly if outcomes are not snacks, after meals, at bedtime,
been using continuous glucose being met. prior to exercise, when hypo-
monitoring, continuous sub- glycemia is suspected, after
cutaneous insulin infusion, and/ Use in Schools treating low blood glucose
or automated insulin delivery Instructions for device use should be levels until they are normo-
for diabetes management should outlined in the student’s diabetes medi- glycemic, when hyperglycemia
have continued access across cal management plan (DMMP). A backup
is suspected, and prior to and
plan should be included in the DMMP
third-party payers, regardless while performing critical tasks
for potential device failure (e.g., BGM,
of age or A1C levels. E such as driving. B
CGM, and/or insulin delivery devices).
7.4 Students should be supported 7.8 Health care professionals should
School nurses and designees should
prandial insulin doses). The specific needs Surveillance Program provides information platforms (19). People with diabetes
and goals of the person with diabetes on the performance of devices used for should be taught how to use BGM data
should dictate BGM frequency and timing BGM (diabetestechnology.org/surveillance/). to adjust food intake, physical activity,
or the consideration of CGM use. As rec- In one analysis, 6 of the top 18 glucose or pharmacologic therapy to achieve
ommended by the device manufacturers meters met the accuracy standard (12). specific goals. The ongoing need for and
and the U.S. Food and Drug Administra- In a subsequent analysis with updated frequency of BGM should be reevaluated
tion (FDA), people with diabetes using glucose meters, 14 of 18 glucose meters at each routine visit to ensure its effec-
CGM must have access to BGM for mul- met the minimum accuracy requirements tive use (17,20,21).
tiple reasons, including whenever there (13). There are single-meter studies in
is suspicion that the CGM is inaccurate, which benefits have been found with People With Diabetes on Intensive Insulin
Table 7.1—Comparison of ISO 15197:2013 and FDA blood glucose meter accuracy standards
Setting FDA (248,254) ISO 15197:2013 (255)
Home use 95% within 15% for all BG in the usable BG range† 95% within 15% for BG $100 mg/dL
99% 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/dL 99% in A or B region of consensus error grid‡
95% within 12 mg/dL for BG <75 mg/dL
98% within 15% for BG $75 mg/dL
98% 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 endmemo.com/medical/unitconvert/Glucose.php. †The range of blood glucose values for which the meter has been proven accurate and
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 (256).
S114 Diabetes Technology Diabetes Care Volume 46, Supplement 1, January 2023
with type 2 diabetes taking basal insulin care professionals in intensive care unit
Table 7.2—Interfering substances for
with or without oral agents and/or non- settings need to be particularly aware of glucose meter readings
insulin injectables. However, for those the potential for abnormal meter readings Glucose oxidase monitors
taking basal insulin, assessing fasting glu- during critical illness, and laboratory-based Uric acid
cose with BGM to inform dose adjust- values should be used if there is any Galactose
ments to achieve blood glucose targets doubt. Xylose
results in lower A1C (23,24). Some meters give error messages if Acetaminophen
L-DOPA
In people with type 2 diabetes not meter readings are likely to be false (33).
taking insulin, routine glucose monitor- Ascorbic acid
ing may be of limited additional clinical Oxygen. Currently available glucose mon- Glucose dehydrogenase monitors
benefit. By itself, even when combined itors utilize an enzymatic reaction linked
7.15 In people with diabetes on levels are rising or falling rapidly). There with iCGM designation and FDA approval
multiple daily injections or are two basic types of CGM devices: for use with AID systems.
continuous subcutaneous insulin those that are owned by the user, un-
infusion, real-time continuous blinded, and intended for frequent/con- Benefits of Continuous Glucose
tinuous use, including real-time CGM Monitoring
glucose monitoring devices
should be used as close to (rtCGM) and intermittently scanned CGM Data From Randomized Controlled Trials
daily as possible for maximal (isCGM), and professional CGM devices Multiple randomized controlled trials (RCTs)
benefit. A Intermittently scanned that are owned and applied in the clinic, have been performed using rtCGM devices,
which provide data that are blinded or and the results have largely been positive
continuous glucose monitor-
unblinded for a discrete period of time. in terms of reducing A1C levels and/or
ing devices should be scanned
CGM, continuous glucose monitoring; isCGM, intermittently scanned CGM; rtCGM, real-time CGM.
S116 Diabetes Technology Diabetes Care Volume 46, Supplement 1, January 2023
type 1 diabetes and met its primary In an observational study in youth with births, length of stay, and neonatal hypo-
outcome of a reduction in rates of hy- type 1 diabetes, a slight increase in A1C glycemia (97). An observational cohort
poglycemia (49). In adults with type 2 di- and weight was seen, but the device was study that evaluated the glycemic vari-
abetes on insulin, two studies were associated with a high user satisfaction ables reported using rtCGM and isCGM
done; one study did not meet its pri- rate (82). found that lower mean glucose, lower
mary end point of A1C reduction (76) Retrospective data from rtCGM use in standard deviation, and a higher percentage
but achieved a secondary end point of a Veterans Affairs population (90) with of time in target range were associated
a reduction in hypoglycemia, and the type 1 and type 2 diabetes treated with with lower risk of large-for-gestational-age
other study met its primary end point insulin showed that the use of rtCGM births and other adverse neonatal out-
of an improvement in Diabetes Treat- significantly lowered A1C and reduced comes (98). Use of the rtCGM-reported
ment Satisfaction Questionnaire score rates of emergency department visits or mean glucose is superior to use of glu-
some cases, this has been linked to the syringes may be used for insu- available for purchase as either pens or
presence of isobornyl acrylate, a skin lin delivery considering individ- vials, others may be available in only one
sensitizer that can cause an additional ual and caregiver preference, form or the other, and there may be signif-
spreading allergic reaction (111–113). insulin type, dosing therapy, icant cost differences between pens and
Patch testing can sometimes identify cost, and self-management vials (see Table 9.4 for a list of insulin
the cause of contact dermatitis (114). capabilities. C product costs with dosage forms). Insulin
Identifying and eliminating tape allergens 7.21 Insulin pens or insulin injection pens may allow people with vision im-
is important to ensure the comfortable pairment or dexterity issues to dose
aids should be considered for
use of devices and promote self-care insulin accurately (145–147), and insulin
people with dexterity issues or
(115–118). In some instances, using an injection aids are also available to
vision impairment to facilitate
implanted sensor can help avoid skin reac- help with these issues. (For a helpful
the accurate dosing and ad-
tions in those sensitive to tape (119,120). list of injection aids, see consumerguide.
ministration of insulin. C
7.22 Connected insulin pens can be diabetes.org/collections/injection-aids). In-
Substances and Factors Affecting haled insulin can be useful in people who
helpful for diabetes manage-
Continuous Glucose Monitoring Accuracy have an aversion to injection.
ment and may be used in
Sensor interference due to several medi- The most common syringe sizes are
cations/substances is a known potential people with diabetes using
1 mL, 0.5 mL, and 0.3 mL, allowing doses
source of CGM measurement errors injectable therapy. E
of up to 100 units, 50 units, and 30 units
(Table 7.4). While several of these sub- 7.23 U.S. Food and Drug Adminis-
of U-100 insulin, respectively. In a few
stances have been reported in the various tration–approved insulin dose
parts of the world, insulin syringes still
CGM brands’ user manuals, additional calculators/decision support sys-
have U-80 and U-40 markings for older
interferences have been discovered after tems may be helpful for titrat-
insulin concentrations and veterinary in-
the market release of these products. Hy- ing insulin doses. C
sulin, and U-500 syringes are available
droxyurea, used for myeloproliferative dis- for the use of U-500 insulin. Syringes are
orders and hematologic conditions, is one Injecting insulin with a syringe or pen generally used once but may be reused
of the most recently identified interfer- (127–143) is the insulin delivery method by the same individual in resource-limited
ing substances that cause a temporary used by most people with diabetes settings with appropriate storage and
increase in sensor glucose values discrepant (134,144), although inhaled insulin is cleansing (147).
from actual glucose values (121–126). also available. Others use insulin pumps or Insulin pens offer added convenience
Therefore, it is crucial to routinely review AID devices (see INSULIN PUMPS AND AUTOMATED by combining the vial and syringe into a
the medication list of the person with di- INSULIN DELIVERY SYSTEMS). For people with dia- single device. Insulin pens, allowing push-
abetes to identify possible interfering betes who use insulin, insulin syringes button injections, come as disposable
substances and advise them accordingly and pens are both able to deliver insulin pens with prefilled cartridges or reusable
on the need to use additional BGM if sen- safely and effectively for the achievement insulin pens with replaceable insulin car-
sor values are unreliable due to these of glycemic targets. Individual preferences, tridges. Pens vary with respect to dosing
substances. cost, insulin type, dosing therapy, and increment and minimal dose, ranging
self-management capabilities should be from half-unit doses to 2-unit dose in-
INSULIN DELIVERY considered when choosing among delivery crements. U-500 pens come in 5-unit
Insulin Syringes and Pens systems. Trials with insulin pens generally dose increments. Some reusable pens
Recommendations show equivalence or small improvements include a memory function, which can
7.20 For people with insulin-requiring in glycemic outcomes compared with us- recall dose amounts and timing. Con-
diabetes on multiple daily injec- ing a vial and syringe. Many individuals nected insulin pens are insulin pens with
tions, insulin pens are preferred with diabetes prefer using a pen due to its the capacity to record and/or transmit in-
in most cases. Still, insulin simplicity and convenience. It is important sulin dose data. Insulin pen caps are also
to note that while many insulin types are available and are placed on existing insulin
S118 Diabetes Technology Diabetes Care Volume 46, Supplement 1, January 2023
pens and assist with calculating insulin 7.25 Insulin pump therapy alone with and adults (155). There is no consensus
doses. Some connected insulin pens and or without sensor-augmented to guide choosing which form of insulin
pen caps can be programmed to calculate pump low glucose suspend administration is best for a given individ-
insulin doses and provide downloadable feature and/or automated insu- ual, and research to guide this decision-
data reports. These pens and pen caps lin delivery systems should be making process is needed (155). Thus, the
are useful to people with diabetes for choice of MDI or an insulin pump is often
offered for diabetes manage-
real-time insulin dosing and allow clini- based upon the characteristics of the per-
ment to youth and adults on
cians to retrospectively review the insu- son with diabetes and which method is
multiple daily injections with
lin delivery times and in some cases most likely to benefit them. DiabetesWise
type 1 diabetes A or other
doses and glucose data in order to (DiabetesWise.org) and the PANTHER
types of insulin-deficient dia-
make informed insulin dose adjustments Program (pantherprogram.org) have help-
Complications of the pump can be quality of life, and preventing long-term systems eventually may be truly auto-
caused by issues with infusion sets (dis- complications. Based on shared decision- mated, currently used hybrid closed-
lodgement, occlusion), which place indi- making by people with diabetes and loop systems require the manual entry
viduals at risk for ketosis and DKA and health care professionals, insulin pumps of carbohydrates consumed to calcu-
thus must be recognized and managed may be considered in all children and late prandial doses, and adjustments for
early (165). Other pump skin issues adolescents with type 1 diabetes. In partic- physical activity must be announced. Mul-
included lipohypertrophy or, less fre- ular, pump therapy may be the preferred tiple studies using various systems with
quently, lipoatrophy (166,167) and pump mode of insulin delivery for children under varying algorithms, pumps, and sensors
site infection (168). Discontinuation of 7 years of age (185). Because of a paucity have been performed in adults and chil-
pump therapy is relatively uncommon of data in adolescents and youth with dren (191–200). Evidence suggests AID sys-
Do-It-Yourself Closed-Loop Systems diabetes clinic have been published (224). programs, which vary in terms of their
Recommendation The FDA approves and monitors clinically effectiveness (236,237). There are lim-
7.28 Individuals with diabetes may validated, digital, and usually online ited RCT data for many of these inter-
be using systems not approved health technologies intended to treat a ventions, and long-term follow-up is
by the U.S. Food and Drug medical or psychological condition; these lacking. However, for an individual with
Administration, such as do-it- are known as digital therapeutics or diabetes, opting into one of these pro-
“digiceuticals” (fda.gov/medical-devices/ grams can be helpful in providing support
yourself closed-loop systems
digital-health-center-excellence/device- and, for many, is an attractive option.
and others; health care profes-
software-functions-including-mobile-medical-
sionals cannot prescribe these
applications) (225). Other applications, Inpatient Care
systems but should assist in
such as those that assist in displaying or
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