Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

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

NCT ID NCT07240012

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 305 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 during pregnancy planning and during pregnancy: * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diabete type 1 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.