Automated insulin delivery versus usual insulin care before and during pregnancy for women with type 1 diabetes
Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
This study tries to see if starting the CamAPS FX automated insulin delivery system before or in early pregnancy helps women with type 1 diabetes keep blood sugar in range more and supports healthier fetal growth compared with usual insulin care with continuous glucose monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 305 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 8 sites (Aalborg, Aalborg and 7 other locations) |
| Trial ID | NCT07240012 on ClinicalTrials.gov |
What this trial studies
This is a national, open-label, randomized controlled trial in Denmark comparing the CamAPS FX automated closed-loop insulin delivery system with usual insulin modality (multiple daily injections or pump) combined with compatible continuous glucose monitoring. Women planning pregnancy (randomized before conception and followed for up to 52 weeks) or women already pregnant at under 14 completed weeks are randomized to start CamAPS FX or continue usual insulin care. Participants are followed through pregnancy, delivery, and until one month after delivery, with primary outcomes including maternal time in glycemic target ranges and fetal growth measures. The trial is conducted at multiple university-affiliated centers with local referral back to pregnancy diabetes care as needed.
Who should consider this trial
Good fit: Women aged 18–45 with type 1 diabetes for at least 12 months who are either planning pregnancy within 52 weeks or are pregnant with a single intrauterine fetus under 14 weeks and who can read and speak Danish are ideal candidates.
Not a fit: Women who cannot communicate in Danish, have severe psychiatric or other medical barriers, have multiple pregnancies, or do not meet the age or diabetes-duration criteria are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the intervention could increase time spent with blood glucose in target and reduce abnormal fetal growth and pregnancy-related complications.
How similar studies have performed: Automated closed-loop systems have improved time-in-range in nonpregnant adults and small pregnancy pilot studies have shown promising results, but large randomized trials in early pregnancy remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg, Aalborg and 7 other locations
- Department of Gynecology and Obstetrics, Aalborg University Hospital — Aalborg, Aalborg, Denmark (Recruiting)
- Department of Gynecology and Obstetrics, Aarhus University Hospital — Aarhus, Aarhus N, Denmark (Not_yet_recruiting)
- Steno Diabetes Center Aarhus — Aarhus, Aarhus N, Denmark (Not_yet_recruiting)
- Steno Diabetes Center Nordjylland — Aalborg, Gistrup, Denmark (Recruiting)
- Steno Diabetes Center Copenhagen — Copenhagen, Herlev, Denmark (Not_yet_recruiting)
- Department of Gynecology and Obstetrics, Odense University Hospital — Odense, Odense C, Denmark (Recruiting)
- Steno Diabetes Center Odense, Odense University Hospital — Odense, Odense C, Denmark (Recruiting)
- Center for Pregnant Women with Diabetes, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Lene Ringholm Chief physician, PhD, Associate Professor
- Email: lene.ringholm.02@regionh.dk
- Phone: +45 35458671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.