Automated Insulin Delivery for Women with Type 1 Diabetes

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

Recruiting N/A Interventional Study
Diabete Type 1 Pregnancy Complications
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 45
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
305 (estimated)
Sponsor
Rigshospitalet, Denmark · Other
Who this trial is looking for

This trial is looking for women aged 18-45 with type 1 diabetes who are planning to become pregnant or are already pregnant. Participants will use an automated insulin delivery system to help manage their diabetes during this time.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a woman aged 18-45 years
  • I have had type 1 diabetes for at least 12 months
  • I am not pregnant and have a negative pregnancy test
  • I plan to become pregnant within 52 weeks
  • I am pregnant with one living baby confirmed by ultrasound
  • I agree to participate in the study during and after my pregnancy

You may not be able to join if

  • I cannot understand Danish
  • I have severe mental or psychiatric issues
  • I have other serious health problems that affect my participation

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility 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…
Contacts

Lene Ringholm Chief physician, PhD, Associate Professor

+45 35458671

lene.ringholm.02@regionh.dk

CONTACT