- Design
- Single-arm, multicentre pivotal trial, 13 weeks
- Population
- 307 adults aged 19 to 85 with insulin-treated type 2 diabetes
- Primary outcome
- Change in HbA1c from baseline to 13 weeks
- Effect
- 8.1% to 7.4%, change −0.7 (95% CI −0.9 to −0.6); time in range 57% to 73%
This was a single-arm, multicentre pivotal trial of one automated insulin delivery system in 307 adults aged 19 to 85 with insulin-treated type 2 diabetes. Baseline CGM data were collected, then participants used the system for 13 weeks. The primary outcome was change in HbA1c. Published in Diabetes Care in October 2026.
Mean HbA1c fell from 8.1% to 7.4%, a change of −0.7 percentage points (95% CI −0.9 to −0.6). Time in range 70–180 mg/dL rose from 57% to 73%. The largest effect was in people starting at HbA1c 9.0% or above, and the benefit held in those continuing a GLP-1 receptor agonist or SGLT2 inhibitor. Hypoglycaemia stayed low, there was no severe hypoglycaemia, and one participant had diabetic ketoacidosis.
There was no control arm, so some of the improvement may reflect trial attention and closer follow-up. It does show the approach is workable in type 2 diabetes on insulin, which until recently was largely a type 1 technology. Cost and access will decide its place in India.
- Consider automated insulin delivery for people on multiple daily injections with HbA1c persistently above 9%.
- Keep GLP-1 receptor agonists or SGLT2 inhibitors going alongside it; benefit held on top of them.
- Teach ketone checks with pump therapy, especially if an SGLT2 inhibitor is continued.
- Expect the gain to be smaller in people already near target.
Why it matters
Closed-loop insulin is no longer only a type 1 conversation for patients stuck on high-dose injections.
Don't overread it
Single-arm and 13 weeks long, so it cannot say how much better this is than optimised injections.
The statistics, in plain English
A fall of 0.7 percentage points is clinically meaningful. But with no comparison group, part of it could be regression to the mean (people enrol when their numbers are bad) and the effect of being in a trial. The 16-point rise in time in range is about four extra hours a day in range.
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