A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes.
Summary
In 319 insulin-treated adults with type 2 diabetes, automated insulin delivery reduced HbA1c by 0.6 percentage points more than control over 13 weeks and increased time-in-range by 14 percentage points, with low hypoglycemia risk. All CGM hyperglycemia metrics favored AID.
Key Findings
- HbA1c decreased by 0.9% with AID vs 0.3% with control; adjusted difference −0.6% (95% CI −0.8 to −0.4; P<0.001).
- Time-in-range (70–180 mg/dL) increased from 48% to 64% with AID vs 51% to 52% with control; mean difference 14 percentage points (P<0.001).
- CGM hyperglycemia metrics were significantly better with AID; hypoglycemia was low in both groups with one severe event in AID.
Clinical Implications
Clinicians can consider AID to improve glycemic control and time-in-range in insulin-treated type 2 diabetes, with minimal increased hypoglycemia risk over 13 weeks.
Why It Matters
This multicenter RCT in NEJM provides high-level evidence that AID benefits insulin-treated type 2 diabetes, a population historically excluded from closed-loop trials.
Limitations
- Short follow-up duration (13 weeks) limits assessment of long-term safety and durability.
- Potential lack of blinding and single-industry sponsorship may introduce bias.
Future Directions
Longer-term, diverse-population trials assessing durability, cost-effectiveness, quality of life, and rare adverse events; head-to-head comparisons among AID algorithms in type 2 diabetes.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Multicenter randomized controlled trial with prespecified outcomes.
- Study Design
- OTHER