Status:
RECRUITING
Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
The Novo Nordic Foundation
mylife Diabetes Care AG
Conditions:
Diabete Type 1
Pregnancy Complications
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 preg...
Detailed Description
This is a national multi-center open-label randomized controlled trial investigating whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early ...
Eligibility Criteria
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:
- 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 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT07240012
Start Date
December 1 2025
End Date
October 1 2028
Last Update
January 14 2026
Active Locations (8)
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1
Department of Gynecology and Obstetrics, Aalborg University Hospital
Aalborg, Aalborg, Denmark, 9000
2
Department of Gynecology and Obstetrics, Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
3
Steno Diabetes Center Aarhus
Aarhus, Aarhus N, Denmark, 8200
4
Steno Diabetes Center Nordjylland
Aalborg, Gistrup, Denmark, 9260