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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabete Type 1 Pregnancy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Automated closed-loop insulin delivery (AID)

Group Type EXPERIMENTAL

Automated closed-loop insulin delivery

Intervention Type DEVICE

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

Usual insulin treatment modality

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Automated closed-loop insulin delivery

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No