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.
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
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
Rigshospitalet, Denmark
Lead sponsor
The Novo Nordic Foundation
Collaborator
mylife Diabetes Care AG
Collaborator
Abbott
Collaborator