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Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes

RecruitingNAAges 18 Years - 45 YearsFemaleCopenhagen University Hospital, Rigshospitalet
NCT07240012 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Automated closed-loop insulin delivery
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Where

8 sites
Department of Gynecology and Obstetrics, Aalborg University Hospital
Aalborg, Denmark
Department of Gynecology and Obstetrics, Aarhus University Hospital
Aarhus, Denmark
Steno Diabetes Center Aarhus
Aarhus, Denmark
Steno Diabetes Center Nordjylland
Aalborg, Denmark
Steno Diabetes Center Copenhagen
Copenhagen, Denmark
Department of Gynecology and Obstetrics, Odense University Hospital
Odense, Denmark
Steno Diabetes Center Odense, Odense University Hospital
Odense, Denmark
Center for Pregnant Women with Diabetes, Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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