Actively Recruiting
Automated Insulin Delivery Versus Usual Insulin Treatment Modality 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
147 weeks
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
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
Official 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
- Have had type 1 diabetes for 12 months or more
- For pregnancy planning: Not currently pregnant confirmed by a negative pregnancy test on the day of randomization
- Planning to become pregnant within 52 weeks
- For pregnancy: Pregnant with a single living fetus confirmed by ultrasound between 8+0 and 13+6 weeks gestation
- Willing to participate during pregnancy, delivery, and up to one month after delivery
You will not qualify if you...
- Unable to understand spoken or written Danish
- Severe mental or psychiatric conditions or other serious diseases as decided by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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