Title: Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial
Author: Lori M. Laffel, Lauren G. Kanapka, Roy W. Beck, Katherine Bergamo, Mark A. Clements, Amy Criego, Daniel J. DeSalvo, Robin Goland, Korey Hood, David Liljenquist, Laurel H. Messer, Roshanak Monzavi, Thomas J. Mouse, Priya Prahalad, Jennifer Sherr, Jill H. Simmons, R. Paul Wadwa, Ruth S. Weinstock, Steven M. Willi, Kellee M. Miller
Abstract: Importance 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  years; 76 [50%] were female; mean [SD] diabetes duration, 9  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.