Automated insulin delivery versus usual insulin care before and during pregnancy for women with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Gynecology and Obstetrics, Aalborg University Hospital
  Aalborg, Aalborg, Denmark Recruiting
• Department of Gynecology and Obstetrics, Aarhus University Hospital
  Aarhus, Aarhus N, Denmark Recruiting
• Steno Diabetes Center Aarhus
  Aarhus, Aarhus N, Denmark Recruiting
• Steno Diabetes Center Nordjylland
  Aalborg, Gistrup, Denmark Recruiting
• Steno Diabetes Center Copenhagen
  Copenhagen, Herlev, Denmark Recruiting
• Department of Gynecology and Obstetrics, Odense University Hospital
  Odense, Odense C, Denmark Recruiting

Study contacts

• Study coordinator: Lene Ringholm Chief physician, PhD, Associate Professor
• Email: lene.ringholm.02@regionh.dk
• Phone: +45 35458671

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.