NCT04292509

Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy

Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy With Predictive Stop Before Low Compared to Stop on Low: an Open-label Crossover RCT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Pregnant Women With Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	SAP with stop before low	cross-over comparison from stop on low to stop before low
DEVICE	SAP with stop on low	cross-over comparison from stop before low to stop on low

Timeline

• Start date: 2020-02-15
• Primary completion: 2020-06-15
• Completion: 2020-07-15
• First posted: 2020-03-03
• Last updated: 2021-09-30

Locations

1 site across 1 country: Belgium