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
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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.
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In young children with type 1 diabetes, rtCGM use reduced hypoglycemia.
“Data in children show that rtCGM use in young children with type 1 diabetes reduced hypoglycemia”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [49]
Behavioral support of parents of young children with diabetes using rtCGM reduced hypoglycemia concerns and diabetes distress.
“children with diabetes using rtCGM showed the benefits of reducing hypoglycemia concerns and diabetes distress (38,49,58).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [49]
Continuous glucose monitoring, when combined with individualized diabetes education or behavioral interventions, has demonstrated greater improvement on glycemic and psychosocial outcomes compared with continuous glucose monitoring alone.
“Continuous glucose monitoring, when combined with individualized diabetes education or behavioral interventions, has demonstrated greater improvement on glycemic and psychosocial outcomes compared with continuous glucose monitoring alone (63,64).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:<i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [64]
Behavioral family interventions support adjustment to a new treatment plan or technology.
“or to support adjustment to a new treatment plan or technology (64).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:<i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [64]
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- Authors
- Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group, Laffel, L., Harrington, K., Hanono, A., Naik, N., Ambler-Osborn, L., Schultz, A., DiMeglio, L., Woerne, S., Jolivette, H., Ismail, H., Tebbe, M., Newman, A., Legge, M., Tamborlane, W., Van Name, M., Weyman, K., Finnegan, J., Steffen, A., Zgorski, M., DeSalvo, D., Hilliard, M., DeLaO, K., Xie, C., Levy, W., Wadwa, R. P., Forlenza, G., Majidi, S., Alonso, G., Weber, I., Clay, M., Simmons, E., Nathan, B., Sunni, M., Sweet, J., Pappenfus, B., Kogler, A., Ludwig, M., Nelson, B., Street, A., Weingartner, D., Albanese-O’Neill, A., Haller, M., Adams, J., Cintron, M., Thomas, N., Kelley, J., Simmons, J., William, G., Brendle, F., Goland, R., Williams, K., Gandica, R., Pollak, S., Casciano, E., Robinson, E., Willi, S., Minnock, P., Olivos, D., Carchidi, C., Grant, B., Wong, J. C., Adi, S., Corathers, S., Sheanon, N., Fox, C., Weis, T., MacLeish, S., Wood, J., Casey, T., Campbell, W., McGuigan, P., Wintergerst, K., Watson, S., Kingery, S., Pierce, G., Ruch, H., Rayborn, L., Rodriguez-Luna, M., & Deuser, A.
- ORCID
- Laffel, Lori
- Harrington, Kara
- Hanono, Anat
- Schultz, Alan
- DiMeglio, Linda
- Ismail, Heba
- Tamborlane, William
- DeSalvo, Daniel
- Hilliard, Marisa
- Levy, Wendy
- Majidi, Shideh
- Alonso, Guy
- Nathan, Brandon
- Sunni, Muna
- Albanese-O’Neill, Anastasia
- Haller, Michael
- Thomas, Nicole
- Kelley, Jennifer
- Williams, Kristen
- Robinson, Elizabeth
- Willi, Steven
- Wong, Jenise C.
- Corathers, Sarah
- Sheanon, Nicole
- MacLeish, Sarah
- Wood, Jamie
- Wintergerst, Kupper
- Watson, Sara
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2020-12-17
- Volume
- 44
- Issue
- 2
- Pages
- 464-472
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC9162100
- OpenAlex
- W3111935839
- Cited by
- 95
- References
- 30
- Citations by year
- 2026: 20 · 2025: 11 · 2024: 11 · 2023: 20 · 2022: 26 · 2021: 7
- FWCI
- 9.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- The Leona M. And Harry B. Helmsley Charitable Trust
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- continuous glucose monitoring, type 1 diabetes, young children, glycemic control, time in range, hypoglycemia, parental quality of life, diabetes education, pediatric diabetes
- MeSH terms
- Adolescent, Blood Glucose, Child, Child, Preschool, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Quality of Life, Blood Glucose Self-Monitoring
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