A twelve-month extension followed the randomised trial of the Omnipod 5 automated insulin delivery system, with 75 adults with type 1 diabetes in France either continuing on the system or transitioning to it from non-automated pump therapy.
From trial baseline to the end of the extension, time in range 70-180 mg/dL rose by 17.9 percentage points to 62.3%, about 4.3 extra hours a day. Time above range and mean sensor glucose both fell, and HbA1c dropped from 8.33% to 7.18%, a fall of 1.14 points. Quality-of-life and hypoglycaemia-confidence scores were maintained or improved. Adverse events were infrequent at 12 per 100 person-years.
The useful part is the duration rather than the size of the effect. Short trials of automated delivery routinely show a first-quarter improvement; the open question has been whether it survives contact with ordinary life once the novelty and the study contact fade. Here it did, in both those who started on the system and those who switched later. When counselling someone hesitant about the cost or the commitment, the honest framing is that the benefit is real, sustained, and larger than most drug intensifications achieve.
- Time in range up 17.9 points to 62.3%, roughly 4.3 hours a day
- HbA1c fell 1.14 points, from 8.33% to 7.18%
- Gains held at twelve months for both continuing and newly switched users
- Quality of life and hypoglycaemia confidence maintained or improved
The statistics, in plain English
All the glycaemic comparisons carry p-values below 0.0001, but the more informative number is the size: 17.9 percentage points of time in range is about 4.3 hours a day, which is a change a patient feels rather than a statistical one. Note this is an extension study without a concurrent control arm, so the comparison is against these same participants at baseline, not against a group who stayed on pump therapy.
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