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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

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posted on 18.12.2020, 00:38 by Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group, Linda A. DiMeglio, Lauren G. Kanapka, Daniel J. DeSalvo, Marisa E. Hilliard, Lori M. Laffel, William V. Tamborlane, Michelle A. Van Name, Stephanie Woerner, Saleh Adi, Anastasia Albanese-O'Neill, G. Todd Alonso, Barbara J. Anderson, Sarah D. Corathers, Kelly Fegan-Bohm, Greg P. Forlenza, Rachelle G. Gandica, Robin S. Goland, Michael J. Haller, Anat Hanono, Kara R. Harrington, Heba M Ismail, Heather A. Jolivette, Jennifer C. Kelley, Suzanne Kingery, Sarah A. MacLeish, Shideh Majidi, Kellee M. Miller, Pantea P. Minnock, Brandon M. Nathan, Nicole M. Sheanon, Jill H. Simmons, Muna Sunni, R. Paul Wadwa, Sara E. Watson, Kate Weyman, Kristen M. Williams, Steven M. Willi, Kupper A. Wintergerst, Jamie Wood
Objective: This study evaluated the effects of continuous glucose monitoring (CGM) combined with family behavioral intervention (CGM+FBI) and CGM alone (Standard-CGM) on glycemic outcomes and parental quality of life compared with blood glucose monitoring (BGM) in children ages 2 to <8 years 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.

Funding

Supported by the Leona M. and Harry B. Helmsley Trust; Dexcom Inc provided non-finacial support.

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