Actively Recruiting
Automated Insulin Delivery Versus Usual Insulin Treatment Before and During Pregnancy in Women With Type 1 Diabetes
Led by Rigshospitalet, Denmark · Updated on 2026-01-14
305
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
T
The Novo Nordic Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether using the automated insulin delivery system CamAPS FX during pregnancy planning or early pregnancy can improve blood sugar control and fetal growth in women with type 1 diabetes. This national multi-center open-label randomized controlled trial compares the CamAPS FX system to usual insulin treatment methods combined with continuous glucose monitoring. The study focuses on women aged 18 to 45 with type 1 diabetes who are planning pregnancy or are in early pregnancy. Participants will be randomly assigned to either start using the CamAPS FX automated insulin delivery system or continue their usual insulin treatment with continuous glucose monitoring. Women planning pregnancy will begin their assigned treatment before conception and continue throughout pregnancy until one month after delivery, or for up to 52 weeks if they do not become pregnant. Those pregnant at the start will follow their assigned treatment until one month post-delivery. During the study, participants will be closely monitored through continuous glucose data, insulin and carbohydrate tracking, blood tests including HbA1c, and fetal growth assessments via ultrasound. Researchers will evaluate time spent in target blood sugar range and birthweight as primary outcomes, along with various secondary measures such as pregnancy and birth complications, neonatal health, and maternal weight. The study lasts until one month after delivery or up to 52 weeks for those not becoming pregnant, with ongoing safety and health assessments.
CONDITIONS
Brief Title
Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years
- Diagnosed with type 1 diabetes for at least 12 months
- Planning to become pregnant within 52 weeks with a negative pregnancy test at randomization (for pregnancy planning group)
- Pregnant with a single living fetus confirmed by ultrasound between 8+0 and 13+6 weeks gestation (for early pregnancy group)
- Agree to participate during pregnancy, delivery, and until one month after delivery
You will not qualify if you...
- Unable to understand Danish language for oral and written information
- Severe mental, psychiatric barriers, or concurrent disease as determined by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks if not pregnant; otherwise from pregnancy planning or early pregnancy until one month post-delivery
Participants begin either automated insulin delivery or continue their usual insulin treatment modality combined with continuous glucose monitoring, starting during pregnancy planning or early pregnancy and continuing through pregnancy, delivery, and up to one month post-delivery.
Study visits during pregnancy, delivery, and one month post-delivery
Trial Site Locations
Total: 8 locations
1
Department of Gynecology and Obstetrics, Aalborg University Hospital
Aalborg, Aalborg, Denmark, 9000
Actively Recruiting
2
Department of Gynecology and Obstetrics, Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
Not Yet Recruiting
3
Steno Diabetes Center Aarhus
Aarhus, Aarhus N, Denmark, 8200
Not Yet Recruiting
4
Steno Diabetes Center Nordjylland
Aalborg, Gistrup, Denmark, 9260
Actively Recruiting
5
Steno Diabetes Center Copenhagen
Copenhagen, Herlev, Denmark, 2730
Not Yet Recruiting
6
Department of Gynecology and Obstetrics, Odense University Hospital
Odense, Odense C, Denmark, 5000
Actively Recruiting
7
Steno Diabetes Center Odense, Odense University Hospital
Odense, Odense C, Denmark, 5000
Actively Recruiting
8
Center for Pregnant Women with Diabetes, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
L
Lene Ringholm Chief physician, PhD, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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