Status:
COMPLETED
Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
University Hospital, Ghent
Universitair Ziekenhuis Brussel
Conditions:
Type1 Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Multi-centric open-label randomized controlled trial (RCT) with 11 Belgian centers and one Dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility and cost-effectiv...
Detailed Description
Women will be recruited with a singleton pregnancy up to 12 weeks gestation. Participants will be randomized 1/1 to 780 pump or standard of care (continue with current treatment of insulin pump withou...
Eligibility Criteria
Inclusion
- Women with type 1 diabetes (T1DM), diagnosed with T1DM at least 1 year before pregnancy
- Age 18-45 years
- A singleton pregnancy confirmed by b-HCG in blood and/or ultrasound-confirmed gestational age up to 11 weeks and 6 days.
- Treated with intensive insulin treatment (either MDI or insulin pump). A closed-loop system can only be used in manual mode.
- Have a booking HbA1c (measurement taken at the first antenatal clinic visit after confirmed pregnancy) level ≤10%.
- Participants need to speak and understand Flemish, French or English and have e-mail access.
Exclusion
- The use of a closed-loop insulin delivery system in auto mode.
- A twin (multiple) pregnancy
- A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician)
- Medications known to interfere with glucose metabolism
- An insulin dose of ≥1.5 units/kg
- Known allergy to adhesives due to infusion set and/or CGM
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2023
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04520971
Start Date
January 15 2021
End Date
May 10 2023
Last Update
December 10 2024
Active Locations (12)
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1
OLV Aalst-Asse
Aalst, Oost-Vlaanderen, Belgium, 9300
2
Imelda Bonheiden
Bonheiden, Belgium, 2820
3
AZ St Jan Brugge
Bruges, Belgium, 8000
4
UZ Brussel
Brussels, Belgium, 1090