Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes (AID-DM)

Rigshospitalet

Status

Enrolling

Conditions

Pregnancy Complications

Diabete Type 1

Treatments

Device: Automated closed-loop insulin delivery

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07240012

3080181

Details and patient eligibility

About

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.

Full description

This is a national multi-center open-label randomized controlled trial investigating whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy (<14 completed weeks) improves maternal glycemic control in women with type 1 diabetes during pregnancy, delivery and post-delivery and leads to more appropriate fetal growth compared to usual insulin treatment modality (multiple day injections or insulin pump) combined with continuous glucose monitoring.

Women planning pregnancy will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring, as per randomisation allocation before conception and throughout pregnancy until one month post-delivery or for up to 52 weeks if not becoming pregnant. Women who become pregnant during the 52-week study period will be referred to their local center for pregnant women with diabetes and followed during pregnancy until one month post-delivery. Women who do not become pregnant during the 52-week study period will leave the study and continue usual diabetes care at their usual diabetes center.

Women who are pregnant at randomisation will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring as per randomisation allocation, throughout the pregnancy period until one month post-delivery.

Enrollment

305 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and 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