AiDAPT
Trial question
What is the role of hybrid closed loop insulin therapy in pregnant patients with T1DM?
Study design
Multi-center
Open label
RCT
Population
124 female patients
Inclusion criteria: pregnant patients with T1DM and a glycated hemoglobin level ≥ 6.5%
Key exclusion criteria: non-T1DM; untreated celiac disease or hypothyroidism; known or suspected insulin allergy; advanced nephropathy, severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy; very good or very poor glycemic control
Interventions
N=61 closed loop (use of smartphone hosting CamAPS FX application communicating with Dana Diabecare RS insulin pump and Dexcom G6 continuous glucose monitor; glucose target < 5.5 mmol/L)
N=63 standard care (continued multiple daily injections or insulin pump therapy with insulin dose adjustment as directed by the local team aiming for standard glucose targets)
Primary outcome
Time with glucose level in range 63-140 mg/dL
68.2
55.6
68.2 %
51.2 %
34.1 %
17.1 %
0.0 %
Closed loop
Standard care
Significant increase ▲
NNH = 7
Significant increase in time with glucose level in range 63-140 mg/dL (68.2% vs. 55.6%; AD 10.5%, 95% CI 7 to 14)
Secondary outcomes
Significant decrease in time with glucose level > 140 mg/dL (29.2% vs. 41.4%; AD -10.2%, 95% CI -13.8 to -6.6)
Significant increase in overnight time with glucose level in range 63-140 mg/dL (70.8% vs. 56.7%; AD 12.3%, 95% CI 8.3 to 16.2)
Significant increase in time with glucose level in range 63-180 mg/dL (87% vs. 80%; AD 6%, 95% CI 3 to 9)
Safety outcomes
No significant differences in severe hypoglycemia, device-related adverse events with continuous glucose monitor.
Conclusion
In pregnant patients with T1DM and a glycated hemoglobin level ≥ 6.5%, closed loop was superior to standard care with respect to time with glucose level in range 63-140 mg/dL.
Reference
Tara T M Lee, Corinne Collett, Simon Bergford et al. Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes. N Engl J Med. 2023 Oct 5.
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