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Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
Sponsor: Rigshospitalet, Denmark
Summary
A national multi-center open-label randomized controlled trial that investigates whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy improves maternal time in glycemic targets and fetal growth in women with type 1 diabetes compared to usual insulin treatment modality combined with Continuous Glucose Monitoring.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
305
Start Date
2025-12-01
Completion Date
2028-10
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
Automated closed-loop insulin delivery
Automated closed-loop insulin delivery and The mylife CamAPS FX algorithm combined with CGM
Locations (8)
Department of Gynecology and Obstetrics, Aalborg University Hospital
Aalborg, Aalborg, Denmark
Department of Gynecology and Obstetrics, Aarhus University Hospital
Aarhus, Aarhus N, Denmark
Steno Diabetes Center Aarhus
Aarhus, Aarhus N, Denmark
Steno Diabetes Center Nordjylland
Aalborg, Gistrup, Denmark
Steno Diabetes Center Copenhagen
Copenhagen, Herlev, Denmark
Department of Gynecology and Obstetrics, Odense University Hospital
Odense, Odense C, Denmark
Steno Diabetes Center Odense, Odense University Hospital
Odense, Odense C, Denmark
Center for Pregnant Women with Diabetes, Rigshospitalet
Copenhagen, Denmark