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RecruitingNot ApplicableNCT07240012

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

Sponsor

Rigshospitalet, Denmark

Enrollment

305 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Pregnancy ComplicationsDiabete Type 1

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria9

  • 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 Criteria2

  • 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

Interventions

DEVICEAutomated closed-loop insulin delivery

Automated closed-loop insulin delivery and The mylife CamAPS FX algorithm combined with CGM

Locations(8)

Department of Gynecology and Obstetrics, Aalborg University Hospital

Aalborg, Aalborg, Denmark

Department of Gynecology and Obstetrics, Aarhus University Hospital

Aarhus, Aarhus N, Denmark

Steno Diabetes Center Aarhus

Aarhus, Aarhus N, Denmark

Steno Diabetes Center Nordjylland

Aalborg, Gistrup, Denmark

Steno Diabetes Center Copenhagen

Copenhagen, Herlev, Denmark

Department of Gynecology and Obstetrics, Odense University Hospital

Odense, Odense C, Denmark

Steno Diabetes Center Odense, Odense University Hospital

Odense, Odense C, Denmark

Center for Pregnant Women with Diabetes, Rigshospitalet

Copenhagen, Denmark

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NCT07240012

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