Open-Source Automated Insulin Delivery Shown to Be Safe, Effective for Type 1 Diabetes

Using an open-source automated insulin[1] delivery system — a software program that is freely shared, without ownership by any company or regulatory approval — was shown to be safe and effective for both adults and children with type 1 diabetes[2], according to a new study[3] presented at the 2022 Scientific Sessions of the American Diabetes Association (ADA) and described in a news release[4] from the organization.

Automated insulin delivery systems — also known as hybrid closed-loop systems[5], or artificial pancreases — use a software algorithm to adjust insulin delivery on an insulin pump[6], based on a person’s individual glucose trends and input from a continuous glucose monitoring (CGM) system[7]. The first such system was approved by the U.S Food and Drug Administration (FDA) in 2016, but many people with diabetes have been using automated insulin delivery technology since before then — by using an open-source system. Open-source software effectively isn’t owned by anyone, and can be used by anyone free of charge. Its developers often create and maintain it as a labor of love, taking user feedback into account when updating it.

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The most widely used open-source automated insulin delivery software is known as OpenAPS, and the latest study compared this software — using an Android smartphone with the DANA-i insulin pump and Dexcom G6 GCM system — with standard sensor-augmented insulin pump therapy, without automated insulin delivery. The study participants were 48 children and 49 adults with type 1 diabetes, who were randomly assigned to use either OpenAPS or standard sensor-augmented insulin delivery for 24 weeks. The main outcome the researchers were interested in was the amount of time spent within a target glucose range of 70 to 180 mg/dl during the final two weeks of the study.

Open-source automated insulin delivered linked to increased time in range

The researchers found that both children and adults benefited from the open-source automated insulin delivery, with adults spending an average of 9.6% more time and children spending an average of 9.9% more time spent in the target glucose range compared with the beginning of the study. The average amount of time spent in range for automated insulin delivery users during the final two weeks of the study was 74.5% for adults and 67.5% for children. Participants who were assigned to standard sensor-augmented insulin pump therapy, on the other hand, did not experience any overall increase in time spent in the target glucose range.

What’s more, 60% of participants in the open-source automated insulin delivery group met the widely used threshold of 70% of their time spent in the target glucose range. In comparison, only 15% of participants in the sensor-augmented pump therapy group met the threshold of 70% of time spend in the target glucose range.

“While open-source [automated insulin delivery] is not yet approved by the FDA, we know people worldwide are using it to manage their diabetes,” said study author Martin de Bock, PhD, a pediatric endocrinologist at the University of Otago in Christchurch, New Zealand, in the news release. “Our findings demonstrate that this is a safe and effective technology and adds to the body of evidence supporting use of open-source [automated insulin delivery] for improving glycemic outcomes.”

Want to learn more about automated insulin delivery? Read “Hybrid Closed-Loop Insulin Pump Systems”[9] and “Hybrid Closed-Loop Technology.”[10]

  1. insulin:
  2. type 1 diabetes:
  3. a new study:
  4. news release:
  5. hybrid closed-loop systems:
  6. insulin pump:
  7. continuous glucose monitoring (CGM) system:
  8. sign up for our free newsletters:
  9. “Hybrid Closed-Loop Insulin Pump Systems”:
  10. “Hybrid Closed-Loop Technology.”:

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