Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in… (NCT07240012) | Clinical Trial Compass
RecruitingNot Applicable
Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
Denmark305 participantsStarted 2025-12-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time in range
Timeframe: From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.
2
Neonatal outcome: Birthweight
Timeframe: At delivery
Trial details
NCT IDNCT07240012
SponsorRigshospitalet, Denmark
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-10
Contact for this trial
Lene Ringholm Chief physician, PhD, Associate Professor