An interventional study of SAP with stop before low and SAP with stop on low in Pregnant Women With Type 1 Diabetes, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Other
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.
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.
149 studies on the registry are indexed under Pregnancy in Diabetics; 33 are open to participants now.
This study's enrollment of 12 is below the median of 90 across 88 interventional studies indexed under Pregnancy in Diabetics.
Browse Pregnancy in Diabetics studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sensor-augmented pump therapy with the use of the predictive stop before low mode of action
Device: SAP with stop before low
Sensor-augmented pump therapy with the use of the predictive stop on low mode of action
Device: SAP with stop on low
cross-over comparison from stop on low to stop before low
cross-over comparison from stop before low to stop on low
blood ketones > 0.6mmol/l.
ketonaemia
Time frame: 4 weeks
mean concentration of blood ketones
Time frame: 4 weeks
mean time of suspension of insulin delivery
Time frame: 4 weeks
frequency of hospitalization due to ketonaemia
Time frame: 4 weeks
mean glucose based on CGM
Time frame: 4 weeks
time >140 mg/dl
Time frame: 4 weeks
time >180 mg/dl
Time frame: 4 weeks
time <63 mg/dl
Time frame: 4 weeks
time <50mg/dl
Time frame: 4 weeks
coefficient of variation of glycaemic measurements
Time frame: 4 weeks
standard deviation of glycaemic measurements
Time frame: 4 weeks
mean amplitude of glucose excursions
Time frame: 4 weeks
HbA1c
Time frame: 4 weeks
time 70-180 mg/dL
Time frame: 4 weeks
frequency of CGM use >80% of time
CGM compliance
Time frame: 4 weeks
total insulin dose
Time frame: 4 weeks
severe hypoglycemic episodes
defined as requiring third-party assistance and/or capillary glucose \<50 mg/dL associated with clinical symptoms
Time frame: 4 weeks
Plan to share: No
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven