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

Not Applicable

Completed

• Conditions: Pregnant Women With Type 1 Diabetes
• Interventions: Device: SAP with stop on low; Device: SAP with stop before low

• Registration Number: NCT04292509
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 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.

Study Timeline

• Study Start: 2020-02-15
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Primary Completion: 2020-06-15
• Study Completion: 2020-07-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• 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 Criteria

• a physical or psychological disease likely to interfere with the conduct of the study
• medications known to interfere with glucose metabolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SAP with stop on low	SAP with stop on low	Sensor-augmented pump therapy with the use of the predictive stop on low mode of action
SAP with predictive stop before low	SAP with stop before low	Sensor-augmented pump therapy with the use of the predictive stop before low mode of action

Primary Outcome Measures

Name	Time	Method
blood ketones > 0.6mmol/l.	4 weeks	ketonaemia

Secondary Outcome Measures

Name	Time	Method
mean time of suspension of insulin delivery	4 weeks
frequency of hospitalization due to ketonaemia	4 weeks
time >140 mg/dl	4 weeks
time <50mg/dl	4 weeks
standard deviation of glycaemic measurements	4 weeks
HbA1c	4 weeks
mean glucose based on CGM	4 weeks
frequency of CGM use >80% of time	4 weeks	CGM compliance
time <63 mg/dl	4 weeks
mean concentration of blood ketones	4 weeks
time >180 mg/dl	4 weeks
coefficient of variation of glycaemic measurements	4 weeks
mean amplitude of glucose excursions	4 weeks
time 70-180 mg/dL	4 weeks
total insulin dose	4 weeks
severe hypoglycemic episodes	4 weeks	defined as requiring third-party assistance and/or capillary glucose \<50 mg/dL associated with clinical symptoms

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium