Clinical Outcomes
International diabetes experts recently collaborated to provide recommendations on how to optimize CGM-derived glucose data collection in clinical studies, including the specific glucose metrics and specific glucose metrics that should be evaluated. These consensus recommendations have been endorsed by key professional organizations, including the American Association of Clinical Endocrinologists, the American Diabetes Association, the Association of Diabetes Care and Education Specialists, Diabetes India, the European Association for the Study of Diabetes, the International Society for Pediatric and Adolescent Diabetes, the Japanese Diabetes Society, and the Juvenile Diabetes Research Foundation. This recommended standardized approach to CGM data collection and reporting in clinical trials will encourage the use of uniform metrics and enhance the interpretability of CGM data. Managed care and payer professionals should note that these metrics offer a body of useful information beyond HbA1c to inform therapeutic and treatment decisions, particularly related to hypoglycemia, postprandial hyperglycemia, and glucose variability.
Battelino T, Alexander CM, Amiel SA, et al. Continuous glucose monitoring and metrics for clinical trials: an international consensus statement. Lancet Diabetes Endocrinol. 2023;11:42-57.
Learn MoreThe 2023 Standards of Medical Care in Diabetes found Grade A evidence supporting the use of RT-CGM in adults with T1D or T2D on intensive insulin therapy and in adults with T2D on basal insulin. The American Diabetes Association (ADA) found Grade B evidence supporting the use of RT-CGM in children and adolescents with T1D on intensive insulin therapy and Grade E evidence for use of RT-CGM in children and adolescents with T2D on intensive insulin therapy. When used as an adjunct to pre- and postprandial BGM, RT-CGM can help to achieve HbA1c targets in pregnant patients with diabetes (Grade B). Based on input from experts, the ADA recommends continued access to RT-CGM through third party payers to people who have been using this technology.
American Diabetes Association. 7. Diabetes Technology: Standards of Care in Diabetes—2023. Diabetes Care. 2022; 46(Suppl 1):S111-S27.
Learn MoreDuring a session at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease held in December, Dr. Peter Reaven discussed the benefits of continuous glucose monitoring (CGM) beyond improved glycemic control. In an analysis of electronic health records from adults with type 1 diabetes (T1D) and type 2 diabetes (T2D) seen in Veterans Affairs (VA) clinics, use of CGM was associated with superior HbA1c reduction and a lower risk of hospitalization. The cohort included >50,000 adults with T1D or T2D who were either CGM users or non-users. CGM users with T1D had a lower risk of admissions to emergency rooms or hospitals for hypoglycemia-related events (HR=0.69 95% CI, 0.48, 0.98; P=0.04), a lower risk of hypoglycemia events in general (HR=0.72; 95% CI, 0.57-0.91; P=0.01), and a lower risk of all-cause hospitalization (HR=0.75; 95% CI, 0.63-0.9; P=0.002) than non-users. CGM users with T2D had a lower risk of hyperglycemia events (HR=0.87; 95% CI, 0.77-0.99; P=0.04) and all-cause hospitalization (HR=0.89; 95% CI, 0.82-0.97; P=0.004) than non-users. In a preliminary analysis, the researchers also calculated mortality risk using propensity score overlap weighting. CGM users with T1D had a lower risk for mortality at 18 months than non-CGM users (adjusted HR=0.38; 95% CI, 0.28-0.51; P<0.001). CGM users with T2D likewise had a reduced mortality risk compared with non-users (aHR=0.79; 95% CI, 0.7-0.88; P<0.001). Dr. Reaven noted that these findings signal a call-to-action for more widespread CGM use, giving managed care and payer professionals cause for consideration in developing coverage policies.
Reaven P. Presented at: 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. December 1-3, 2022; Universal City, CA.
Learn MoreIn an analysis of available data, accuracy metrics from preapproval trials of the G5, G6, and G7 real-time continuous glucose monitoring (RT-CGM) systems were compared after propensity score adjustments were applied to balance baseline demographic characteristics. Metrics included mean absolute relative differences (MARD) between CGM and YSI values (from the YSI, Inc., 2300 Stat Plus system) and the proportion of CGM values within 20% or 20 mg/dL of the YSI values (“%20/20”). Ease-of-use was also evaluated by formal task analysis in the study. Accuracy performance of the G7 sensors, whether placed on the arm or abdomen, was similar to that of abdomen-placed G5 and G6 sensors, and egregious errors were rare with all three systems. Based on the formal task analysis, the authors concluded that simplification of the sensor insertion process should result in G7 being even easier to learn and several software improvements may contribute to better glycemic outcomes. Payer professionals may well find confidence in the comparative usability data for the latest RT-CGM system versus previous versions of the technology when considering updates to coverage policies.
Welsh JB, Psavko S, Zhang X, Gao P, Balo AK. Comparisons of Fifth-, Sixth-, and Seventh-Generation Continuous Glucose Monitoring Systems. J Diabetes Sci Technol. 2022:19322968221099879.
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