Smart insulin system aims to protect moms and babies in diabetes pregnancy

NCT ID NCT07240012

Recruiting now Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests whether an automated insulin delivery system (CamAPS FX) can help women with type 1 diabetes maintain better blood sugar control before and during pregnancy, compared to their usual insulin routine. The trial will enroll 305 women aged 18-45 who are either planning pregnancy or in early pregnancy. The goal is to improve time in target blood sugar range and reduce risks like abnormal fetal growth.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Automated closed-loop insulin delivery system (CamAPS FX algorithm with continuous glucose monitor)
What this could lead to: If successful, this could offer a more effective way to manage blood sugar during pregnancy, potentially reducing complications for both mother and baby.
What could go wrong: This is a relatively early-stage trial with 305 participants, and results may not apply to all. The device may not work as well in real-world settings or could have technical issues.

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Conditions

The condition(s) this trial relates to.

pregnancy disorder type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DIABETE TYPE 1 PREGNANCY COMPLICATIONS

Contacts and locations

Locations

Center for Pregnant Women with Diabetes, Rigshospitalet
RECRUITING

Copenhagen, 2100, Denmark
Department of Gynecology and Obstetrics, Aalborg University Hospital
RECRUITING

Aalborg, Aalborg, 9000, Denmark
Department of Gynecology and Obstetrics, Aarhus University Hospital
RECRUITING

Aarhus, Aarhus N, 8200, Denmark
Department of Gynecology and Obstetrics, Odense University Hospital
RECRUITING

Odense, Odense C, 5000, Denmark
Steno Diabetes Center Aarhus
RECRUITING

Aarhus, Aarhus N, 8200, Denmark
Steno Diabetes Center Copenhagen
RECRUITING

Copenhagen, Herlev, 2730, Denmark
Steno Diabetes Center Nordjylland
RECRUITING

Aalborg, Gistrup, 9260, Denmark
Steno Diabetes Center Odense, Odense University Hospital
RECRUITING

Odense, Odense C, 5000, Denmark

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