Findings from the first randomized controlled clinical trial to show the benefit and safety of an open-source automated insulin delivery (AID) system — also known as a do-it-yourself (DIY) artificial pancreas or closed-loop system — have now been published, along with a commentary supporting its use.
Data from the CREATE (Community Derived Automated Insulin Delivery) trial were first released at the American Diabetes Association 82nd Scientific Sessions in June, as reported by Medscape Medical News.
The findings have now been published online in the New England Journal of Medicine by Mercedes J. Burnside, MBChB, and colleagues.
AID systems link an insulin pump and a continuous glucose monitor (CGM) with an algorithm that automatically adjusts insulin delivery to optimize glycemic control.
Open-source DIY AID systems were developed prior to commercial approval of branded AIDs and are used by thousands of people worldwide with type 1 diabetes. They are not approved by regulatory bodies, and concerns about their safety remain. In 2019, the US Food and Drug Administration warned against the use of any nonapproved devices or algorithms.
CREATE was designed to address those concerns by comparing an open-source AID system (OpenAPS with modified AndroidAPS) to insulin pump therapy and CGM (without any communication between the two) in 97 adults and children with type 1 diabetes, most of whom were naive to AID systems, explain Burnside, of the University of Otago and the Canterbury District Health Board, Christchurch, New Zealand, and coauthors.
In an accompanying editorial, Sue A. Brown, MD, writes that the CREATE data “further support the feasibility of implementing an open-source system in a multisite study of new open-source users.”
Brown notes that open-source technologies often permit “customizations” that are not available with current commercially available AIDs. The benefits of this for tailored glycemic control “and the availability of open-source documentation have been balanced against perceived concerns about difficulty in configuration and maintenance, lack of regulatory approval, and the limited availability of trial data for evaluation,” she notes.
CREATE Shows Superior Performance, “Reassuring” Data on AIDs
In the CREATE trial, time spent in target blood glucose range increased from 61.2% to 71.2% in the AID group at 24 weeks but declined from 57.7% to 54.5% in controls (P < .001), with no significant difference by age.
There were no severe hypoglycemic or diabetic ketoacidosis events in either group, although two patients in the AID group withdrew from the trial because of connectivity issues.
Brown, of the Division of Endocrinology, Center for Diabetes Technology, University of Virginia, Charlottesville, calls the CREATE safety data “reassuring” and points out that although the study did not show between-group differences in hypoglycemia, previous observational trials have shown reduced levels of hypoglycemia with AID systems.
Brown also writes that the time-in-range data seen in CREATE are “remarkably consistent” with the 70%-75% seen in prior studies of different device types and algorithms. (The system used in CREATE was a modified version of AndroidAPS 2.8 with a standard OpenAPS 0.7.0 algorithm, paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, with an Android smartphone application as the user interface.)
She concludes: “This trial of an open-source configuration showed the superior performance of an AID system in yet another clinical trial…In the face of an alarming trend in which technology use is resulting in increased healthcare disparities, these advances need to be accompanied by efforts to ensure that these beneficial systems are equitably accessible.”
Burnside had no disclosures. Brown has reported receiving research grants from Insulet, Dexcom, Roche Diabetes Care, Tandem Diabetes Care, and Tolerion.
N Engl J Med. Published online September 7, 2022. Article, Editorial
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter: @MiriamETucker.
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