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

NCT07240012 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

  • Diabete Type 1
  • Pregnancy Complications

Interventions

DEVICE

Automated closed-loop insulin delivery

Automated closed-loop insulin delivery and The mylife CamAPS FX algorithm combined with CGM

Sponsors & Collaborators

  • The Novo Nordic Foundation

    collaborator OTHER

  • mylife Diabetes Care AG

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07240012 on ClinicalTrials.gov