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
. 2023 Jul;17(4):976-987.
doi: 10.1177/19322968221084667. Epub 2022 Mar 26.

Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study

Michelle A Van Name  1 , Lauren G Kanapka  2 , Linda A DiMeglio  3 , Kellee M Miller  2 , Anastasia Albanese-O'Neill  4 , Persis Commissariat  5 , Sarah D Corathers  6 , Kara R Harrington  5 , Marisa E Hilliard  7 , Barbara J Anderson  7 , Jennifer C Kelley  8 , Lori M Laffel  5 , Sarah A MacLeish  9 , Brandon M Nathan  10 , William V Tamborlane  1 , R Paul Wadwa  11 , Steven M Willi  12 , Kristen M Williams  13 , Kupper A Wintergerst  14 , Stephanie Woerner  3 , Jenise C Wong  15 , Daniel J DeSalvo  7
Affiliations
Randomized Controlled Trial

Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study

Michelle A Van Name et al. J Diabetes Sci Technol. 2023 Jul.

Abstract

Objectives: Achieving optimal glycemic outcomes in young children with type 1 diabetes (T1D) is challenging. This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia.

Study design: This one-year study included an initial 26-week randomized controlled trial of CGM with FBI (CGM+FBI) and CGM alone (Standard-CGM) compared with blood glucose monitoring (BGM), followed by a 26-week extension phase wherein the BGM Group received the CGM+FBI (BGM-Crossover) and both original CGM groups continued this technology.

Results: Time in range (70-180 mg/dL) did not improve with CGM use (CGM+FBI: baseline 37%, 52 weeks 41%; Standard-CGM: baseline 41%, 52 weeks 44%; BGM-Crossover: 26 weeks 38%, 52 weeks 40%). All three groups sustained decreases in hypoglycemia (<70 mg/dL) with CGM use (CGM+FBI: baseline 3.4%, 52 weeks 2.0%; Standard-CGM: baseline 4.1%, 52 weeks 2.1%; BGM-Crossover: 26 weeks 4.5%, 52 weeks 1.7%, P-values <.001). Hemoglobin A1c was unchanged with CGM use (CGM+FBI: baseline 8.3%, 52 weeks 8.2%; Standard-CGM: baseline 8.2%, 52 weeks 8.0%; BGM-Crossover: 26 weeks 8.1%, 52 weeks 8.3%). Sensor use remained high (52-week study visit: CGM+FBI 91%, Standard-CGM 92%, BGM-Crossover 88%).

Conclusion: Over 12 months young children with T1D using newer CGM technology sustained reductions in hypoglycemia and, in contrast to prior studies, persistently wore CGM. However, pervasive hyperglycemia remained unmitigated. This indicates an urgent need for further advances in diabetes technology, behavioral support, and diabetes management educational approaches to optimize glycemia in young children.

Keywords: behavioral intervention; continuous glucose monitoring; glycemic control; hypoglycemia; young children.

PubMed Disclaimer

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: M.A.V.N., L.G.K., L.A.D., K.M.M., A.A.-O., P.C., S.D.C., K.R.H., M.E.H., B.J.A., J.C.K., S.A.M., B.M.N., W.V.T., K.M.W., K.A.W., S.W., and J.C.W. have no disclosures to report. L.M.L. reports grants and personal fees from Dexcom, outside the submitted work. R.P.W. reports grants from Dexcom, Eli Lilly, and Tandem Diabetes Care and personal fees from Dompe and Tandem Diabetes Care outside the submitted work. S.M.W. reports personal fees from Roche Diagnostics and Boehringer Ingelheim, outside the submitted work. D.J.D. reports research support from Insulet and personal fees from Dexcom outside the submitted work.

Figures

Figure 1.
Figure 1.
Flowchart of study. Abbreviations: CGM, continuous glucose monitoring; FBI, family behavioral intervention; BGM, blood glucose monitoring; RCT, randomized controlled trial.
Figure 2.
Figure 2.
Percent of time in range 70 to 180 mg/dL by treatment group and visit. Abbreviations: CGM, continuous glucose monitoring; FBI, family behavioral intervention; BGM, blood glucose monitoring; RCT, randomized controlled trial.
Figure 3.
Figure 3.
Percent of time <70 mg/dL by treatment group and visit. Center line represents median, center dot represents mean. Abbreviations: CGM, continuous glucose monitoring; FBI, family behavioral intervention; BGM, blood glucose monitoring; RCT, randomized controlled trial.
See this image and copyright information in PMC

References

    1. Mauras N, Beck R, Xing D, et al.. 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. DiMeglio LA, Kanapka LG, DeSalvo DJ, et al.. Time spent outside of target glucose range for young children with type 1 diabetes: a continuous glucose monitor study. Diabet Med. 2020;37:1308-1315. - PMC - PubMed
    1. Laffel LM, Kanapka LG, Beck RW, et al.. Effect of continuous glucose monitoring on glycemic control in adolescents and young adults with type 1 diabetes: a randomized clinical trial. JAMA. 2020;323:2388-2396. - PMC - PubMed
    1. Pratley RE, Kanapka LG, Rickels MR, et al.. Effect of continuous glucose monitoring on hypoglycemia in older adults with type 1 diabetes: a randomized clinical trial. JAMA. 2020;323:2397-2406. - PMC - PubMed

Publication types