NCT07240012

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Dec 2025Oct 2028

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

January 14, 2026

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

November 16, 2025

Last Update Submit

January 13, 2026

Conditions

Diabete Type 1Pregnancy Complications

Outcome Measures

Primary Outcomes (2)

  • Time in range

    The between group difference in time in range in pregnancy (3.5-7.8 mmol/L) between intervention and controls

    From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.

  • Neonatal outcome: Birthweight

    Offspring birthweight standard deviation score adjusted for gestational age and infant gender.

    At delivery

Secondary Outcomes (14)

  • Continuous glucose monitoring data

    From randomisation during pregnancy planning until delivery or leaving study after 52 weeks (randomized during pregnancy planning) or from randomization in early pregnancy to delivery

  • Insulin and carbohydrates

    Randomization, during pregnancy planning, study visits during pregnancy, around delivery and at one month post-delivery

  • System features

    From inclusion until one month post-delivery

  • HbA1c

    Inclusion, last before pregnancy, at 9, 21, 33 and 35 weeks

  • Severe hypoglycemia

    2 years - if not becoming pregnant in the study period - until leaving the study

  • +9 more secondary outcomes

Study Arms (2)

Automated closed-loop insulin delivery (AID)

EXPERIMENTAL
Device: Automated closed-loop insulin delivery

Usual insulin treatment modality

NO INTERVENTION

Interventions

Automated closed-loop insulin deliveryDEVICE

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

Automated closed-loop insulin delivery (AID)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Department of Gynecology and Obstetrics, Aalborg University Hospital

Aalborg, Aalborg, 9000, Denmark

RECRUITING

Department of Gynecology and Obstetrics, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

NOT YET RECRUITING

Steno Diabetes Center Aarhus

Aarhus, Aarhus N, 8200, Denmark

NOT YET RECRUITING

Steno Diabetes Center Nordjylland

Aalborg, Gistrup, 9260, Denmark

RECRUITING

Steno Diabetes Center Copenhagen

Copenhagen, Herlev, 2730, Denmark

NOT YET RECRUITING

Department of Gynecology and Obstetrics, Odense University Hospital

Odense, Odense C, 5000, Denmark

RECRUITING

Steno Diabetes Center Odense, Odense University Hospital

Odense, Odense C, 5000, Denmark

RECRUITING

Center for Pregnant Women with Diabetes, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Lene Ringholm Chief physician, PhD, Associate Professor

CONTACT

+45 35458671lene.ringholm.02@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician, PhD, Associate Professor

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

January 14, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

IPD will be shared if it is a requirement at our institution.

Locations

DK(8)