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

NCT ID NCT07240012

First seen Nov 20, 2025 · Last updated Jun 23, 2026 · Updated 29 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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

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

    NOT_YET_RECRUITING

    Aarhus, Aarhus N, 8200, Denmark

  • Department of Gynecology and Obstetrics, Odense University Hospital

    RECRUITING

    Odense, Odense C, 5000, Denmark

  • Steno Diabetes Center Aarhus

    NOT_YET_RECRUITING

    Aarhus, Aarhus N, 8200, Denmark

  • Steno Diabetes Center Copenhagen

    NOT_YET_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

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.

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.