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type1.science
Phase 2CompletedACTRN12620000034932

CREATE: open-source automated insulin delivery vs sensor-augmented pump

The first randomized controlled trial of a do-it-yourself, open-source closed-loop system (OpenAPS algorithm in AndroidAPS, the "AnyDANA-loop"). In 97 children and adults with type 1 diabetes, it significantly improved time-in-range versus sensor-augmented pump therapy over 24 weeks, with no severe hypoglycemia or DKA — landmark evidence that community-built automated insulin delivery is safe and effective.

Primary endpoints

  • Percentage of time in target glucose range (70-180 mg/dL; 3.9-10.0 mmol/L) during the final 2 weeks (days 155-168) of the 24-week trial

Results so far

Time-in-range rose from 61.2% to 71.2% with open-source AID but fell from 57.7% to 54.5% in the control group — an adjusted difference of 14 percentage points (95% CI 9.2 to 18.8; P<0.001), equal to about 3 hours 21 minutes more time in range per day, with the largest gains overnight. The benefit was the same in children and adults. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. A 24-week continuation phase confirmed durable benefit (treatment effect +12.2 percentage points over 48 weeks) and safety across different pumps.

The full picture

For years, thousands of people with type 1 diabetes built their own "artificial pancreas" at home — pairing an insulin pump and glucose sensor with free, community-written software that automatically adjusts insulin. These do-it-yourself (DIY) or "open-source" systems were popular and clearly helped users, but they had never been tested in a proper randomized trial, so doctors and regulators couldn't formally recommend them.1 CREATE was the study that changed that.2

What was tested and why it matters. CREATE put a community-built closed-loop system head-to-head against standard care. The open-source system — nicknamed the "AnyDANA-loop" — combined the OpenAPS algorithm running inside a modified AndroidAPS smartphone app, a DANA-i insulin pump, and a Dexcom G6 sensor.13 The comparison group used a sensor-augmented pump: the same kind of pump and sensor, but with the insulin dosing left to the person rather than automated.3

Who it was for. The trial enrolled both children (ages 7-15) and adults (16-70) with type 1 diabetes at four sites in New Zealand, most of whom had not used automated insulin delivery before.24

Design. This was a 24-week, open-label, randomized controlled trial. Of 97 participants (48 children and 49 adults), 44 were assigned to the open-source system and 53 to the control group.2 The main measure was "time in range" — the share of the day glucose sat between 70 and 180 mg/dL — over the final two weeks.2

Key results. Time in range climbed from 61.2% to 71.2% with the open-source system, while slipping from 57.7% to 54.5% in the control group — a 14-percentage-point advantage (95% CI 9.2 to 18.8; P<0.001).2 That works out to about 3 hours 21 minutes more time in a healthy glucose range each day, with the biggest gains coming overnight.25 Children and adults benefited equally, and crucially there were no episodes of severe hypoglycemia or diabetic ketoacidosis in either group.2

What it means and what's next. CREATE is the first randomized evidence that a community-developed, open-source closed-loop system is both safe and effective.5 A 24-week extension found the improvement held up — about a 12-percentage-point gain over 48 weeks — even when participants switched to different pumps.6 The findings give clinicians firmer ground to support patients who choose open-source automated insulin delivery, and they validate a movement built by the diabetes community itself.5

References

  1. Burnside MJ, Lewis DM, Crocket HR, et al. CREATE (Community deRivEd AutomaTEd insulin delivery) trial. Randomised parallel arm open label clinical trial comparing automated insulin delivery using a mobile controller (AnyDANA-loop) with an open-source algorithm with sensor augmented pump therapy in type 1 diabetes. J Diabetes Metab Disord (2020). https://doi.org/10.1007/s40200-020-00547-8 ↩ ↩2

  2. Burnside MJ, Lewis DM, Crocket HR, et al. Open-Source Automated Insulin Delivery in Type 1 Diabetes. N Engl J Med (2022);387:869-881. https://doi.org/10.1056/NEJMoa2203913 ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7

  3. Burnside MJ, Lewis DM, Crocket HR, et al. CREATE trial protocol — AnyDANA-loop system components (OpenAPS algorithm in AndroidAPS, DANA-i pump, Dexcom G6 CGM). J Diabetes Metab Disord (2020). https://doi.org/10.1007/s40200-020-00547-8 ↩ ↩2

  4. Burnside MJ, et al. CREATE trial: recruitment of 100 participants aged 7-70 years (stratified into children 7-15 and adults 16-70) across four sites in New Zealand. J Diabetes Metab Disord (2020). https://doi.org/10.1007/s40200-020-00547-8 ↩

  5. OpenAPS.org. News: NEJM Publishes RCT On Open Source Automated Insulin Delivery Using OpenAPS Algorithm. OpenAPS.org (2022). https://openaps.org/2022/09/08/news-nejm-publishes-rct-on-open-source-automated-insulin-delivery-using-openaps-algorithm/ ↩ ↩2 ↩3

  6. Burnside MJ, Lewis DM, Crocket HR, et al. Extended Use of an Open-Source Automated Insulin Delivery System in Children and Adults with Type 1 Diabetes: The 24-Week Continuation Phase Following the CREATE Randomized Controlled Trial. Diabetes Technol Ther (2023);25:250-259. https://doi.org/10.1089/dia.2022.0484 ↩