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

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

Plain Language Summary

Simplified for easier understanding

This study is comparing an automated insulin delivery system (often called a "closed-loop" or "artificial pancreas" system) to standard insulin treatment for women with Type 1 diabetes who are pregnant or planning to become pregnant. Researchers want to see whether the automated system leads to better blood sugar control and safer pregnancies. **You may be eligible if...** - You are a woman aged 18–45 years with Type 1 diabetes for at least 12 months - You are either planning to become pregnant within 52 weeks (and have a negative pregnancy test at enrollment), OR you are already pregnant (confirmed singleton pregnancy at 8–14 weeks gestation) - You are willing to participate through delivery and up to 1 month after birth **You may NOT be eligible if...** - You are not proficient in Danish (language required for study materials) - You have severe mental health conditions or other major medical barriers as determined by your doctor - You do not meet other health criteria set by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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