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Clinical Trial 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 risk for ketonaemia during type 1 diabetes pregnancies.


Clinical Trial 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 stop on low. Participants will be cross-over to the other group after two weeks (from stop before low to stop on low or vice versa). During the study, participants will be asked to measure blood ketones three times per day. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04292509
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Contact
Status Completed
Phase N/A
Start date February 15, 2020
Completion date July 15, 2020