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. 2024 Mar;26(S3):53-65.
doi: 10.1089/dia.2023.0442.

Real-World Evidence of Automated Insulin Delivery System Use

Elizabeth G Considine  1 , Jennifer L Sherr  1
Affiliations

Real-World Evidence of Automated Insulin Delivery System Use

Elizabeth G Considine et al. Diabetes Technol Ther. 2024 Mar.

Abstract

Objective: Pivotal trials of automated insulin delivery (AID) closed-loop systems have demonstrated a consistent picture of glycemic benefit, supporting approval of multiple systems by the Food and Drug Administration or Conformité Européenne mark receipt. To assess how pivotal trial findings translate to commercial AID use, a systematic review of retrospective real-world studies was conducted. Methods: PubMed and EMBASE were searched for articles published after 2018 with more than five nonpregnant individuals with type 1 diabetes (T1D). Data were screened/extracted in duplicate for sample size, AID system, glycemic outcomes, and time in automation. Results: Of 80 studies identified, 20 met inclusion criteria representing 171,209 individuals. Time in target range 70-180 mg/dL (3.9-10.0 mmol/L) was the primary outcome in 65% of studies, with the majority of reports (71%) demonstrating a >10% change with AID use. Change in hemoglobin A1c (HbA1c) was reported in nine studies (range 0.1%-0.9%), whereas four reported changes in glucose management indicator (GMI) with a 0.1%-0.4% reduction noted. A decrease in HbA1c or GMI of >0.2% was achieved in two-thirds of the studies describing change in HbA1c and 80% of articles where GMI was described. Time below range <70 mg/dL (<3.9 mmol/L) was reported in 16 studies, with all but 1 study showing stable or reduced levels. Most systems had >90% time in automation. Conclusion: With larger and more diverse populations, and follow-up periods of longer duration (∼9 months vs. 3-6 months for pivotal trials), real-world retrospective analyses confirm pivotal trial findings. Given the glycemic benefits demonstrated, AID is rapidly becoming the standard of care for all people living with T1D. Individuals should be informed of these systems and differences between them, have access to and coverage for these technologies, and receive support as they integrate this mode of insulin delivery into their lives.

Keywords: Automated insulin delivery; Closed loop; Real world; Retrospective; Time in range.

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Conflict of interest statement

E.G.C. has no disclosures. J.S. serves, or has served, on advisory panels for Bigfoot Biomedical, Cecelia Health, Insulet Corporation, Medtronic Diabetes, StartUp Health Diabetes Moonshot, and Vertex. J.S. has served as a consultant to Abbott Diabetes, Bigfoot Biomedical, Insulet, Medtronic Diabetes, and Zealand. Yale School of Medicine has received research support for J.S. from Abbott Diabetes, JAEB Center for Health Research, JDRF, Insulet, Medtronic, NIH, and Provention Bio.

Figures

FIG. 1.
FIG. 1.
Systems reported in retrospective real-world publications plotted over time by the year of publication. As some studies included more than one device, those trials have more than one system represented on the graph.
FIG. 2.
FIG. 2.
The proportion of studies with a low risk of bias (high quality) or high risk of bias (low quality).
See this image and copyright information in PMC

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