A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Finger-stick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes
Research Design and Methods: A multicenter (N=14), 6-month, randomized controlled trial including 143 youth 2 to <8 years of age with type 1 diabetes. Primary analysis included treatment group comparisons of percent time in range (TIR, 70-180 mg/dL) across follow-up visits.
Results: About 90% of participants in the CGM groups used CGM ≥ 6 days/week at 6-months. Between-group TIR comparisons showed no significant changes: CGM+FBI vs BGM = 3.2% [95% CI -0.5%, 7.0%], Standard-CGM vs BGM = 0.5% [-2.6% to 3.6%], CGM+FBI vs Standard-CGM = 2.7% [-0.6%, 6.1%]. Mean time <70 mg/dL was reduced from baseline to follow-up in the CGM+FBI (from 5.2% to 2.6%) and Standard-CGM (5.8% to 2.5%) groups , compared with 5.4% to 5.8% with BGM (CGM+FBI vs. BGM, p<0.001, Standard-CGM vs BGM p<0.001). No severe hypoglycemic events occurred in the CGM+FBI group, 1 in the Standard-CGM, and 5 in the BGM. CGM+FBI parents reported greater reductions in diabetes burden and fear of hypoglycemia compared with Standard-CGM (p=0.008 and 0.04) and BGM (p=0.02 and 0.002).Conclusions: CGM used consistently over a 6-month period in young children with type 1 diabetes did not improve TIR but did significantly reduce time in hypoglycemia. The FBI benefited parental well-being.