Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes: a Randomized Controlled Trial: the CRISTAL Study (CRISTAL)

  • End date
    Jun 24, 2023
  • participants needed
  • sponsor
    Universitaire Ziekenhuizen KU Leuven
Updated on 24 October 2022


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-effectiveness of 780 MiniMed Medtronic hybrid closed-loop insulin system (intervention group) compared to standard of care therapy (control group).


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 without closed-loop or multiple daily insulin injections). Participants will be stratified according to study center, baseline Hba1c, and method of insulin delivery (pump or injections). Participants will be followed-up till delivery. To account for differences in the type of continuous glucose monitoring (CGM) used between the intervention group and the control group, the same CGM system as in the 780 insulin pump group (Guardian™ Sensor 3 and once available the Guardian 4 sensor) will be used in a blinded manner in the control group to collect CGM data during at least four different time points in pregnancy: at 14-17 weeks, 20-23 weeks, 26-29 weeks and 33-36 weeks.

Condition Type1 Diabetes
Treatment Standard of Care, 780G
Clinical Study IdentifierNCT04520971
SponsorUniversitaire Ziekenhuizen KU Leuven
Last Modified on24 October 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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