A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes
Authors:   Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group, Laffel Lori , Harrington Kara , Hanono Anat , Naik Nisha , Ambler-Osborn Louise , Schultz Alan , DiMeglio Linda , Woerne Stephanie , Jolivette Heather , Ismail Heba , Tebbe Megan , Newman America , Legge Megan , Tamborlane William , Van Name Michelle , Weyman Kate , Finnegan Jennifer , Steffen Amy , Zgorski Melinda , DeSalvo Daniel , Hilliard Marisa , DeLaO Kylie , Xie Cicilyn , Levy Wendy , Wadwa R. Paul , Forlenza Greg , Majidi Shideh , Alonso Guy , Weber Isabel , Clay Michelle , Simmons Emily , Nathan Brandon , Sunni Muna , Sweet Jessica , Pappenfus Beth , Kogler Anne , Ludwig Marrissa , Nelson Brittney , Street Anne , Weingartner Darcy , Albanese-O’Neill Anastasia , Haller Michael , Adams Janey , Cintron Miriam , Thomas Nicole , Kelley Jennifer , Simmons Jill , William George , Brendle Faith , Goland Robin , Williams Kristen , Gandica Rachelle , Pollak Sarah , Casciano Emily , Robinson Elizabeth , Willi Steven , Minnock Pantea , Olivos Diana , Carchidi Cathy , Grant Brian , Wong Jenise C. , Adi Saleh , Corathers Sarah , Sheanon Nicole , Fox Cathy , Weis Tammy , MacLeish Sarah , Wood Jamie , Casey Terri , Campbell Wendy , McGuigan Paul , Wintergerst Kupper , Watson Sara , Kingery Suzanne , Pierce Gwen , Ruch Heather , Rayborn Lauren , Rodriguez-Luna Manuel , Deuser Amy 
Published: December 2020

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 &lt;8 years with type 1 diabetes.

RESEARCH DESIGN AND METHODS
This was a multicenter (N = 14), 6-month, randomized controlled trial including 143 youth 2 to &lt;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
Approximately 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 with glucose level &lt;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 &lt; 0.001, and Standard-CGM vs. BGM, P &lt; 0.001). No severe hypoglycemic events occurred in the CGM+FBI group, one occurred in the Standard-CGM group, and five occurred in the BGM group. 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.