Status:
COMPLETED
Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Pregnant Women With Type 1 Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The ROKSANA study is an open-label crossover RCT with the aim to evaluate whether sensor-augmented pump therapy (SAP) with predictive low glucose suspend technology is associated with an increased ris...
Detailed Description
10 pregnant women with type 1 diabetes will be included . Participants will be randomized 1/1 between 12-30 weeks of pregnancy to SAP with predictive stop before low during two weeks or predictive sto...
Eligibility Criteria
Inclusion
- type 1 diabetes
- age 18-45 years
- a singleton pregnancy with ultrasound-confirmed gestational age between 12- 30 weeks.
- treated with 640 insulin pump and have a baseline HbA1c level ≤10%.
Exclusion
- a physical or psychological disease likely to interfere with the conduct of the study
- medications known to interfere with glucose metabolism
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04292509
Start Date
February 15 2020
End Date
July 15 2020
Last Update
September 30 2021
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium