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

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

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

Conditions3

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