Open AccessA Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System
Author(s) -
John Lum,
Ryan Bailey,
Victoria Barnes-Lomen,
Diaranjo,
Korey K. Hood,
Rayhan Lal,
Brandon Arbiter,
Adam S. Brown,
Daniel J. DeSalvo,
Jeremy Pettus,
Peter Calhoun,
Roy W. Beck
Publication year - 2021
Publication title -
diabetes technology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.142
H-Index - 88
eISSN - 1557-8593
pISSN - 1520-9156
DOI - 10.1089/dia.2020.0535
Subject(s) - medicine , interquartile range , confidence interval , hypoglycemia , prospective cohort study , incidence (geometry) , rate ratio , observational study , insulin , physics , optics
Objective: To evaluate the safety and effectiveness of the Loop Do-It-Yourself automated insulin delivery system. Research Design and Methods: 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. Results: 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%; P < 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%, P < 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%, P < 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%). Conclusions: 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.