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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
cross-over comparison from stop on low to stop before low
cross-over comparison from stop before low to stop on low
UZ Leuven
Leuven, Belgium
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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