‘Do-it-yourself’ artificial pancreas system beats production line pump in controlled trial

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Diving brief:

  • The ability to customize open-source, do-it-yourself automated insulin delivery (AID) systems can make them more effective control blood sugar than conventional sensor-based insulin pumps, according to a study published last month in the New England Journal of Medicine.
  • This conclusion is supported by the results of a clinical trial of 97 subjects which found that people with type 1 diabetes who used the AID system spent more time in the target range.
  • The AID system consisted of an open-source artificial pancreas running on Android devices, a DANA-i insulin pump, and a Dexcom G6 continuous glucose meter.

Overview of the dive:

Medical technology makers are developing closed-loop artificial pancreas systems, though the pace of progress has lagged behind expectations in some parts of the diabetes community, leading some people to raise the bar on their own. challenge. The result is a free, open-source algorithm known as OpenAPS and a companion application for Android mobile devices, AndroidAPS.

To evaluate the technology, New Zealand researchers randomized 97 patients with type 1 diabetes, including 48 children, to use the AID system or Dexcom G6 CGM with high and low glucose alerts and an insulin pump, either the pre-production DANA-i used in the DIY group or their usual pump.

After 24 weeks, the mean time in target range increased by 10 percentage points in the AID group while decreasing in the control cohort, resulting in a statistically significant difference of 14 percentage points between the two arms. The difference caused the trial to meet its primary endpoint. Patients in the AID group spent 3 hours and 21 minutes longer in the target range per day than their counterparts in the control group.

Investigators recorded no severe hypoglycemia or diabetic ketoacidosis in either group. Two patients in the AID group, a child and an adult, withdrew from the trial due to connectivity issues and frustration with the trial devices. The authors of the NEJM paper stated that “hardware malfunction rather than algorithm performance was the primary burden for patients in the AID group.”

“Open source AIDs may be more customizable and more widely available than commercial systems, although these potential benefits must be weighed against possible difficulties in configuring open source systems, lack of regulatory approval, and data availability. ‘limited trial’, a doctor not connected to the study wrote in an accompanying editorial.

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