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Effect of CGM on Glycemic Control in Adolescents and Young Adults With T1D
abstract
This abstract is available on the publisher's site.
Access this abstract nowImportance
Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated.
Objective
To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes.
Design, Setting, and Participants
Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%.
Interventions
Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79).
Main Outcomes and Measures
The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate.
Results
Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group).
Conclusions and Relevance
Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings.
Trial Registration
ClinicalTrials.gov Identifier: NCT03263494.
Additional Info
Disclosure statements are available on the authors' profiles:
Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial
JAMA 2020 Jun 16;323(23)2388-2396, LM Laffel, LG Kanapka, RW Beck, K Bergamo, MA Clements, A Criego, DJ DeSalvo, R Goland, K Hood, D Liljenquist, LH Messer, R Monzavi, TJ Mouse, P Prahalad, J Sherr, JH Simmons, RP Wadwa, RS Weinstock, SM Willi, KM MillerFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Since the first real-time continuous glucose monitors (CGMs) were approved for home use in 2006, CGMs have revolutionized the way clinicians and patients understand and manage type 1 diabetes (T1D). Adolescents and young adults are faced with unique developmental challenges when managing T1D, and only 14-17% meet glycemic targets.1 While previous data reported low rates of CGM use in adolescents and young adults with T1D,2 in this randomized trial of diverse youth with above target HbA1c levels, sustained CGM use was associated with a clinically significant 0.4% improvement in HbA1c at 26 weeks when compared to those using standard blood glucose monitoring.3 Time in the target range also improved by more than 1.5 hours per day on average, with less time spent in the hypoglycemic and hyperglycemic ranges. These results are encouraging, as CGM uptake will likely continue to improve now that many newer CGMs no longer require fingerstick calibrations to maintain accuracy.
In practice, however, CGMs may not be accessible to everyone with diabetes, especially those with public health insurance. At the end of 2019, only 14 state Medicaid programs covered CGMs for type 1 or type 2 diabetes, and at least 15 states had zero coverage for CGMs.4 This severely limits the ability of clinicians to prescribe CGMs for patients. Thus, there is a dire need to expand Medicaid coverage of these devices to prevent widening socioeconomic health disparities that already exist.
References