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

NCT04292509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-09-30

No results posted yet for this study

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.

Conditions

  • Pregnant Women With Type 1 Diabetes

Interventions

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Katrien Benhalima, MD PhD · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2020-06-15
Completion
2020-07-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04292509 on ClinicalTrials.gov