medwireNews: Closed-loop insulin delivery with the open-source OpenAPS algorithm results in significantly better glucose control than sensor-augmented pump delivery in children and adults in the randomized CREATE trial.
This is the first direct, randomized comparison of an open-source approach with an existing approved technology, and was funded by the Health Research Council of New Zealand.
Presenting the findings, Martin de Bock (University of Otago, New Zealand) said: “I guess we’re hoping that, in some groups where you can’t get commercial automation, that this might provide an avenue for people that deserve to be getting the glucose benefits from automated insulin delivery.”
Previous, nonrandomized trials of open-source closed-loop technologies have generally involved people who are comfortable with diabetes technologies and highly engaged with their blood glucose management.
This current trial recruited people who had been using an insulin pump for at least 6 months, because, explained de Bock, “it was a lot to take on in the first place, so we didn’t want to shift people all the way from [multiple daily injections] through to open-source [closed-loop insulin delivery].”
However, many of the participants had not previously used a continuous glucose monitor (CGM), necessitating a 4-week run-in period to allow them to get used to it. The full closed-loop system involved a Bluetooth-enabled pump, a CGM, and the OpenAPS algorithm on a standard Android phone.
In general, the trial and its findings are “like every other automated insulin delivery trial you’ve seen,” de Bock told delegates at the 82nd ADA Scientific Sessions in New Orleans, Louisiana.
During the last 2 weeks of the 6-month randomized phase, time in range (TIR; 3.9–10.1 mmol/L, 70–180 mg/dL) was an average of 14% higher among participants using the closed-loop system than those using sensor-augmented pump delivery.
The significant improvement was seen from weeks 0–3 and occurred among both the 48 children (median age 13.0 years) and the 49 adults (median age 40.0 years) who were randomized. Six percent of the children and 18% of the adults had previously used a closed-loop system. Baseline glycated hemoglobin was an average of 7.5% (58.4 mmol/mol) in the children and 7.7% (61.1 mmol/mol) in the adults, and TIR was 56.1% and 62.4%, respectively.
By the end of the trial, TIR had improved from 61.2% to 71.2% in the closed-loop group, compared with a 57.7% to 54.5% fall in the sensor-augmented pump group. Sixty percent of people in the closed-loop group achieved TIR above 70%, compared with just 15% of the sensor-augmented pump group.
In common with other closed-loop systems, the OpenAPS-based one was most effective during the night, particularly among adults, in whom TIR was improved by approximately 30% versus sensor-augmented pump delivery. Time in tight range (3.9–7.8 mmol/L, 70–140 mg/dL) improved by an average of 15.8% between the groups and there was no increase in hypoglycemia.
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ADA Scientific Sessions; New Orleans, Louisiana: 3–7 June 2022