Clinical trial NCT04292509: Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women With Type 1 Diabetes
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: open-label cross-over RCT
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: blood ketones > 0.6mmol/l.
timeFrame: 4 weeks
Secondary outcomes:
measure: mean concentration of blood ketones
timeFrame: 4 weeks
measure: mean time of suspension of insulin delivery
timeFrame: 4 weeks
measure: frequency of hospitalization due to ketonaemia
timeFrame: 4 weeks
measure: mean glucose based on CGM
timeFrame: 4 weeks
measure: time >140 mg/dl
timeFrame: 4 weeks
measure: time >180 mg/dl
timeFrame: 4 weeks
measure: time <63 mg/dl
timeFrame: 4 weeks
measure: time <50mg/dl
timeFrame: 4 weeks
measure: coefficient of variation of glycaemic measurements
timeFrame: 4 weeks
measure: standard deviation of glycaemic measurements
timeFrame: 4 weeks
measure: mean amplitude of glucose excursions
timeFrame: 4 weeks
measure: HbA1c
timeFrame: 4 weeks
measure: time 70-180 mg/dL
timeFrame: 4 weeks
measure: frequency of CGM use >80% of time
timeFrame: 4 weeks
measure: total insulin dose
timeFrame: 4 weeks
measure: severe hypoglycemic episodes
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Katrien Benhalima, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benhalima K, van Nes F, Laenen A, Gillard P, Mathieu C. Risk for ketonaemia in type 1 diabetes pregnancies with sensor-augmented pump therapy with predictive low glucose suspend compared with low glucose suspend: a crossover RCT. Diabetologia. 2021 Dec;64(12):2725-2730. doi: 10.1007/s00125-021-05589-y. Epub 2021 Oct 13.