NCT07240012
Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
Recruiting · Not Applicable · Copenhagen University Hospital, Rigshospitalet · registry updated 2026-08-12
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Inclusion criteria during pregnancy planning
- Women, age 18-45 years
- Duration of type 1 diabetes ≥ 12 months
- Women who are not pregnant confirmed by a negative pregnancy test on the day of randomization
- Planning pregnancy within 52 weeks
- Inclusion during pregnancy:
Exclusion
- Exclusion criteria during pregnancy planning and during pregnancy:
- No proficiency in Danish to understand oral and written information
- Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator