“DIY” Closed Loop System Safe, Effective for Adults, Children With Type-1 Diabetes

By Dave Quaile, /alert Contributor

The Loop open source “Do-It-Yourself” automated insulin delivery system can be initiated with community-developed resources and has been deemed safe and effective in child and adult patients with type-1 diabetes, according to new data published in Diabetes Technology and Therapeutics.

“Before closed-loop systems becoming commercially available, ‘Do-It-Yourself’ closed-loop systems were developed by individuals with a personal interest in automating insulin delivery for type 1 diabetes. One such system called ‘Loop’ was developed by Nate Racklyeft, Pete Schwamb, and others in the open-source diabetes software community in 2015,” John W. Lum, MS, from the Jaeb Center for Health Research, in Tampa, Florida, and colleagues wrote in the study. “Loop is being used worldwide by up to 9,000 individuals based on the RileyLink order history, despite limited data on the system's safety and efficacy.”

To provide information on the safety and efficacy of Loop, Lum and colleagues conducted an observational longitudinal study of existing and new Loop users. A total of 558 adults and children aged 1–71 years with a mean HbA1c 6.8% ± 1.0% who initiated Loop either on their own or with community-developed resources and provided data for 6 months were included in the study.

The study was conducted outside of the clinic in a real world setting with all data provided by study participants. Demographic and socioeconomic information, medications, diabetes history and management as well as height and weight were all provided by participants. 

According to the results of the study 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 < .001). 

There was an increase in TIR in both adults and children, across the full range of baseline HbA1c, and in participants with both high- and moderate-income levels, according to the study results.

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 at baseline was 6.8% ± 1.0% 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. 

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%) among users providing Loop data at 6 months (N = 481).

“Open-source AID systems are used by many adults and children to automate insulin delivery for management of T1D, with at least 9000 having used Loop,” the researchers wrote. “The benefits of Loop were seen in both adults and children, across the full range of baseline HbA1c, and with both high- and moderate-income levels.”

Disclosure: Lum reports receiving consulting fees from Bigfoot Biomedical, Eli Lilly and Tandem Diabetes Care.


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