Automated insulin delivery during the first 6 months postpartum (AiDAPT): a prespecified extension study

Area of Science:

• Endocrinology
• Reproductive Medicine
• Medical Technology

Background:

• Clinical guidelines lack specific recommendations for hybrid closed loop (HCL) insulin therapy in the postpartum period.
• The postpartum phase presents unique challenges for managing type 1 diabetes due to newborn care demands.

Purpose of the Study:

• To evaluate the safety and efficacy of HCL use in the first six months postpartum compared to standard diabetes care.
• To assess glycemic control in women with type 1 diabetes during the postpartum period using HCL therapy.

Main Methods:

• A multicentre, randomized controlled trial extension followed 57 women with type 1 diabetes for 6 months postpartum.
• Participants continued their assigned treatment: either standard insulin therapy with continuous glucose monitoring (CGM) or HCL therapy (CamAPS FX).
• The primary outcome was the percentage of time in range (TIR) of 3.9-10.0 mmol/L.

Main Results:

• The HCL group achieved a significantly higher mean time in range (72% vs. 54%) compared to standard care.
• HCL therapy also resulted in reduced hyperglycemia and lower mean glucose levels, with no significant difference in hypoglycemia rates.
• No treatment effect changes were observed based on the postpartum period (0-3 months vs. 3-6 months), and no safety issues arose.

Conclusions:

• Hybrid closed loop therapy is safe and effective for managing type 1 diabetes in the postpartum period.
• Maintaining 70% time in range supports the continued use of HCL over standard insulin therapy after childbirth.