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

Author:

Van Name Michelle A.1,Kanapka Lauren G.2,DiMeglio Linda A.3ORCID,Miller Kellee M.2,Albanese-O’Neill Anastasia4ORCID,Commissariat Persis5ORCID,Corathers Sarah D.6,Harrington Kara R.5,Hilliard Marisa E.7,Anderson Barbara J.7,Kelley Jennifer C.8,Laffel Lori M.5ORCID,MacLeish Sarah A.9,Nathan Brandon M.10,Tamborlane William V.1,Wadwa R. Paul11,Willi Steven M.12,Williams Kristen M.13ORCID,Wintergerst Kupper A.14,Woerner Stephanie3,Wong Jenise C.15ORCID,DeSalvo Daniel J.7

Affiliation:

1. Yale School of Medicine, New Haven, CT, USA

2. Jaeb Center for Health Research, Tampa, FL, USA

3. Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA

4. Department of Pediatrics, University of Florida, Gainesville, FL, USA

5. Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA

6. Cincinnati Children’s Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA

7. Texas Children’s Hospital, Baylor College of Medicine, Houston, TX, USA

8. Vanderbilt University Medical Center, Nashville, TN, USA

9. Rainbow Babies and Children’s Hospital, Cleveland, OH, USA

10. University of Minnesota, Minneapolis, MN, USA

11. Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA

12. Children’s Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

13. Naomi Berrie Diabetes Center, Columbia University, New York, NY, USA

14. Wendy Novak Diabetes Center, University of Louisville, Norton Children’s Hospital, Louisville, KY, USA

15. Madison Clinic for Pediatric Diabetes, University of California San Francisco, San Francisco, CA, USA

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.

Funder

Leona M. and Harry B. Helmsley Charitable Trust

Publisher

SAGE Publications

Subject

Biomedical Engineering,Bioengineering,Endocrinology, Diabetes and Metabolism,Internal Medicine

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