Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes
NCT ID: NCT04520971
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2021-01-15
2023-05-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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780G closed-loop
780 closed-loop insulin delivery system
780G
780G closed-loop insulin delivery system (Medtronic)
standard of care
standard of care treatment (continue with current treatment of insulin pump without closed-loop or multiple daily insulin injections).
standard of care
continue with standard of care treatment (pump without closed-loop or MDI)
Interventions
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780G
780G closed-loop insulin delivery system (Medtronic)
standard of care
continue with standard of care treatment (pump without closed-loop or MDI)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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University Hospital, Ghent
OTHER
Universitair Ziekenhuis Brussel
OTHER
University Hospital, Antwerp
OTHER
Imelda Hospital, Bonheiden
OTHER
AZ Sint-Jan AV
OTHER
AZ Delta
OTHER
Onze Lieve Vrouw Hospital
OTHER
General Hospital Groeninge
OTHER
AZ Nikolaas
OTHER
AZ Turnhout
OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Amsterdam UMC
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Katrien Benhalima, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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OLV Aalst-Asse
Aalst, Oost-Vlaanderen, Belgium
Imelda Bonheiden
Bonheiden, , Belgium
AZ St Jan Brugge
Bruges, , Belgium
UZ Brussel
Brussels, , Belgium
UCLouvain
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
AZ Groeninge Kortrijk
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
AZ Roeselare
Roeselare, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
AZ Turnhout
Turnhout, , Belgium
Amsterdam UMC
Amsterdam, , Netherlands
Countries
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References
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Beunen K, Van Wilder N, Ballaux D, Vanhaverbeke G, Taes Y, Aers XP, Nobels F, Marlier J, Lee D, Cuypers J, Preumont V, Siegelaar SE, Painter RC, Laenen A, Gillard P, Mathieu C, Benhalima K. Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial - study protocol. BMC Pregnancy Childbirth. 2023 Mar 16;23(1):180. doi: 10.1186/s12884-023-05481-0.
Benhalima K, Beunen K, Van Wilder N, Ballaux D, Vanhaverbeke G, Taes Y, Aers XP, Nobels F, Marlier J, Lee D, Cuypers J, Preumont V, Siegelaar SE, Painter RC, Laenen A, Gillard P, Mathieu C. Comparing advanced hybrid closed loop therapy and standard insulin therapy in pregnant women with type 1 diabetes (CRISTAL): a parallel-group, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2024 Jun;12(6):390-403. doi: 10.1016/S2213-8587(24)00089-5. Epub 2024 Apr 30.
Other Identifiers
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S64308
Identifier Type: -
Identifier Source: org_study_id