NCT07240012Recruiting
Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 305 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- Oct 2028
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Type 1 diabetes
- NCT number
- NCT07240012
What you commit to
- Study type: Interventional
- Planned participants: 305
- From 1 Dec 2025 to the primary completion date, Oct 2028
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator
Other
- No proficiency in Danish to understand oral and written information
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Nordjylland Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Department of Gynecology and Obstetrics, Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Department of Gynecology and Obstetrics, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| steno diabetes center Aarhus Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Center for Pregnant Women with Diabetes, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Steno Diabetes Center Odense, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Department of Gynecology and Obstetrics, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.