AiDAPT Trial: Automated Insulin Delivery in Pregnancy Complicated by T1DM

aidapt trial insulin

Year: 2023 Title: AiDAPT TRIAL Subtitle: Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes Type of Trial: Interventional, randomized controlled trial

Objective: To find definitive proof of a benefit to women by using automated closed-loop for about 24 weeks throughout pregnancy in a real-life NHS antenatal care setting.

Participants: 124

Inclusion Criteria:

  • Age 18-45 years
  • A diagnosis of type 1 diabetes
  • A viable pregnancy confirmed by ultrasound and currently on intensive insulin therapy (≥3 injections or CSII)

Exclusion Criteria:

  • Non-type 1 diabetes
  • Any other physical or psychological disease or current treatment with drugs known to interfere with glucose metabolism.


  • Closed-loop group
  • Standard-care group

Primary Outcome:

  • Percentage of time in the target glucose range %
  • Closed-loop group: 68.2 ±10.5
  • Standard-care group: 55.6 ±12.5
  • Mean adjusted difference, 10.5 percentage points (P<0.001)

Secondary Outcomes:

  • Number of instances of adverse events (Severe hypoglycemia)
    • Closed-loop group: 6
    • Standard-care group: 5
  • Number of instances of adverse events (Diabetic ketoacidosis)
    • Closed-loop group: 1
    • Standard-care group: 1

Conclusion: This study provides evidence that among patients with pregnancy complicated by type 1 diabetes, hybrid closed-loop insulin therapy significantly improved maternal glycemic control.

Reference: Lee TTM et al. N Engl J Med 2023; 389:1566-1578

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