Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Feb;44(2):464-472.
doi: 10.2337/dc20-1060. Epub 2020 Dec 17.

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

Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group
Collaborators
Randomized Controlled Trial

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

Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group. Diabetes Care. 2021 Feb.

Abstract

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: This was 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: 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 <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, and Standard-CGM vs. BGM, P < 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.

Trial registration: ClinicalTrials.gov NCT02912728.

PubMed Disclaimer

Figures

Figure 1
Figure 1
TIR 70–180 mg/dL (A) and time with glucose level <70 mg/dL (B) by treatment group and visit.
See this image and copyright information in PMC

References

    1. Mauras N, Beck R, Xing D, et al. .; Diabetes Research in Children Network (DirecNet) Study Group . A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years. Diabetes Care 2012;35:204–210 - PMC - PubMed
    1. Sundberg F, Forsander G. Detection and treatment efficacy of hypoglycemic events in the everyday life of children younger than 7 yr. Pediatr Diabetes 2014;15:34–40 - PubMed
    1. Rovet JF, Ehrlich RM. The effect of hypoglycemic seizures on cognitive function in children with diabetes: a 7-year prospective study. J Pediatr 1999;134:503–506 - PubMed
    1. Rovet JF, Ehrlich RM, Hoppe M. Specific intellectual deficits in children with early onset diabetes mellitus. Child Dev 1988;59:226–234 - PubMed
    1. Ryan CM. Searching for the origin of brain dysfunction in diabetic children: going back to the beginning. Pediatr Diabetes 2008;9:527–530 - PubMed

Publication types