Automated insulin delivery for women with type 1 diabetes planning or starting pregnancy
Compares an automated insulin system with usual insulin treatment in women with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, and Odense, DenmarkSee the 8 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT07240012, who can take part
Where in Denmark
- Department of Gynecology and Obstetrics, Aalborg University HospitalAalborg, DenmarkTaking people
- Steno Diabetes Center NordjyllandAalborg, DenmarkTaking people
- Department of Gynecology and Obstetrics, Aarhus University HospitalAarhus, DenmarkTaking people
- steno diabetes center AarhusAarhus, DenmarkTaking people
- Center for Pregnant Women with Diabetes, RigshospitaletCopenhagen, DenmarkTaking people
- Steno Diabetes Center CopenhagenCopenhagen, DenmarkTaking people
- Department of Gynecology and Obstetrics, Odense University HospitalOdense, DenmarkTaking people
- Steno Diabetes Center Odense, Odense University HospitalOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Trial code
- NCT07240012
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
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: 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:; Women, age 18-45 years; Duration of type 1 diabetes ≥ 12 months; Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks; Accepting participation in the DDBR2 study during pregnancy, delivery and until one month after delivery.
Exclusion: Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator; No proficiency in Danish to understand oral and written information.