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A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System.
A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System. Diabetes technology & therapeutics Lum, J., Bailey, R., Barnes-Lomen, V., Naranjo, D., Hood, K., Lal, R. A., Arbiter, B., Brown, A., DeSalvo, D. J., Pettus, J., Calhoun, P., Beck, R. W. 2020Abstract
OBJECTIVE: To evaluate the safety and effectiveness of the Loop Do-It-Yourself (DIY) 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 to 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 (prior to starting Loop) to 73±13% during the 6 months (mean change from baseline 6.6%, 95% confidence interval 5.9% to 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% confidence interval -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% confidence interval -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 prior to the study. Among the 481 users providing Loop data at 6 months, median CGM use was 96% (interquartile range 91% to 98%) and median time Loop was modulating basal insulin was at least 83% (interquartile range 73% to 88%).CONCLUSIONS: The Loop open source system can be initiated with community-developed resources and used safely and effectively by adults and children with T1D.
View details for DOI 10.1089/dia.2020.0535
View details for PubMedID 33226840