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A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes.

The New England journal of medicine2025-03-19PubMed
Total: 87.0Innovation: 8Impact: 9Rigor: 9Citation: 9

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