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A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System.

Citation
Lum, J. W., et al. “A Real-World Prospective Study Of The Safety And Effectiveness Of The Loop Open Source Automated Insulin Delivery System.”. Diabetes Technology & Therapeutics, pp. 367-375.
Center Stanford University
Author John W Lum, Ryan J Bailey, Victoria Barnes-Lomen, Diana Naranjo, Korey K Hood, Rayhan A Lal, Brandon Arbiter, Adam S Brown, Daniel J DeSalvo, Jeremy Pettus, Peter Calhoun, Roy W Beck
Keywords Automated insulin delivery, Closed-loop control, Continuous glucose monitors, Safety, type 1 diabetes
Abstract

To evaluate the safety and effectiveness of the Loop Do-It-Yourself automated insulin delivery system. A prospective real-world observational study was conducted, which included 558 adults and children (age range 1-71 years, mean HbA1c 6.8% ± 1.0%) who initiated Loop either on their own or with community-developed resources and provided data for 6 months. Mean time-in-range 70-180 mg/dL (TIR) increased from 67% ± 16% at baseline (before starting Loop) to 73% ± 13% during the 6 months (mean change from baseline 6.6%, 95% confidence interval [CI] 5.9%-7.4%;  < 0.001). TIR increased in both adults and children, across the full range of baseline HbA1c, and in participants with both high- and moderate-income levels. Median time <54 mg/dL was 0.40% at baseline and changed by -0.05% (95% CI -0.09% to -0.03%,  < 0.001). Mean HbA1c was 6.8% ± 1.0% at baseline and decreased to 6.5% ± 0.8% after 6 months (mean difference = -0.33%, 95% CI -0.40% to -0.26%,  < 0.001). The incidence rate of reported severe hypoglycemia events was 18.7 per 100 person-years, a reduction from the incidence rate of 181 per 100 person-years during the 3 months before the study. Among the 481 users providing Loop data at 6 months, median continuous glucose monitoring use was 96% (interquartile range [IQR] 91%-98%) and median time Loop modulating basal insulin was at least 83% (IQR 73%-88%). The Loop open source system can be initiated with community-developed resources and used safely and effectively by adults and children with type 1 diabetes.

Year of Publication
2021
Journal
Diabetes technology & therapeutics
Volume
23
Issue
5
Number of Pages
367-375
Date Published
05/2021
ISSN Number
1557-8593
DOI
10.1089/dia.2020.0535
Alternate Journal
Diabetes Technol Ther
PMID
33226840
PMCID
PMC8080906
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