Impact of a Novel Diabetes Support System on a Cohort of Individuals With Type 1 Diabetes Treated With Multiple Daily Injections: A Multicenter Randomized Study

Author:

Bisio Alessandro1,Anderson Stacey1ORCID,Norlander Lisa2,O’Malley Grenye3,Robic Jessica1,Ogyaadu Selassie3,Hsu Liana2,Levister Camilla3,Ekhlaspour Laya2ORCID,Lam David W.3,Levy Carol3ORCID,Buckingham Bruce2,Breton Marc D.1ORCID

Affiliation:

1. 1Center for Diabetes Technology, School of Medicine, University of Virginia, Charlottesville, VA

2. 2School of Medicine, Stanford University, Stanford, CA

3. 3Icahn School of Medicine at Mount Sinai, New York, NY

Abstract

OBJECTIVE Achieving optimal glycemic control for many individuals with type 1 diabetes (T1D) remains challenging, even with the advent of newer management tools, including continuous glucose monitoring (CGM). Modern management of T1D generates a wealth of data; however, use of these data to optimize glycemic control remains limited. We evaluated the impact of a CGM-based decision support system (DSS) in patients with T1D using multiple daily injections (MDI). RESEARCH DESIGN AND METHODS The studied DSS included real-time dosing advice and retrospective therapy optimization. Adults and adolescents (age >15 years) with T1D using MDI were enrolled at three sites in a 14-week randomized controlled trial of MDI + CGM + DSS versus MDI + CGM. All participants (N = 80) used degludec basal insulin and Dexcom G5 CGM. CGM-based and patient-reported outcomes were analyzed. Within the DSS group, ad hoc analysis further contrasted active versus nonactive DSS users. RESULTS No significant differences were detected between experimental and control groups (e.g., time in range [TIR] +3.3% with CGM vs. +4.4% with DSS). Participants in both groups reported lower HbA1c (−0.3%; P = 0.001) with respect to baseline. While TIR may have improved in both groups, it was statistically significant only for DSS; the same was apparent for time spent <60 mg/dL. Active versus nonactive DSS users showed lower risk of and exposure to hypoglycemia with system use. CONCLUSIONS Our DSS seems to be a feasible option for individuals using MDI, although the glycemic benefits associated with use need to be further investigated. System design, therapy requirements, and target population should be further refined prior to use in clinical care.

Publisher

American Diabetes Association

Subject

Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference30 articles.

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2. Centers for Disease Control and Prevention . National Diabetes Statistics Report, 2020. Accessed 16 November 2021. Available from https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

3. Insulin pump use in young children in the T1D Exchange clinic registry is associated with lower hemoglobin A1c levels than injection therapy;Blackman;Pediatr Diabetes,2014

4. The T1D Exchange clinic registry;Beck;J Clin Endocrinol Metab,2012

5. Approach to the adult hospitalized patient on an insulin pump;Lansang;J Hosp Med,2013

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