- Design
- Single-arm, multicentre pivotal trial, 13 weeks
- Population
- 307 adults aged 19-85 with insulin-treated type 2 diabetes
- Primary outcome
- Change in HbA1c from baseline to 13 weeks
- Effect
- -0.7 percentage points (95% CI -0.9 to -0.6); time in range 57% to 73%
The twiist-T2D pivotal study enrolled 307 adults aged 19 to 85 with insulin-treated type 2 diabetes. After a baseline period on CGM, all switched to an automated insulin delivery (AID) system for 13 weeks. There was no comparison group. Published in Diabetes Care on 7 October 2026.
HbA1c fell by 0.7 percentage points, from 8.1% to 7.4%. Time in range (70 to 180 mg/dL) rose from 57% to 73%. The largest falls were in people starting at 9% or above, and benefit was seen even in those already taking a GLP-1 receptor agonist or SGLT2 inhibitor. CGM-measured hypoglycaemia stayed low, there was no severe hypoglycaemia, and one participant had diabetic ketoacidosis.
AID has become standard for type 1 diabetes; this adds to a growing body of evidence in type 2. The design limits what can be concluded: a before-and-after study cannot separate the device from the extra attention and closer follow-up of a trial.
In practice, the candidates are people on multiple daily injections whose HbA1c stays high despite adherence and add-on agents. Cost and access will decide uptake in most Indian clinics; the regulatory position of this device in India is not known.
- Consider AID for adults on intensive insulin whose HbA1c stays at 9% or above despite good adherence
- Keep GLP-1 receptor agonists and SGLT2 inhibitors going when insulin delivery is automated
- Teach ketone checks on pump failure or infusion-set problems, since ketoacidosis can still occur
- Use time in range as well as HbA1c to judge response at follow-up
- Expect the trial setting to flatter results compared with routine clinic use
Why it matters
Automated delivery is no longer only a type 1 conversation; the poorly controlled insulin user with type 2 diabetes is now a candidate.
Don't overread it
Single-arm and 13 weeks long: it shows improvement on the system, not superiority over optimised injections.
The statistics, in plain English
The 95% confidence interval for the HbA1c fall (-0.9 to -0.6 points) is narrow and well away from zero, so the improvement is real within the trial. Without a control group, though, some of it may reflect regression to the mean and the extra support every trial participant receives.
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