Pregnant Women With Type 1 Diabetes
Conditions
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.
Interventions
DEVICESAP with stop before low
cross-over comparison from stop on low to stop before low
DEVICESAP with stop on low
cross-over comparison from stop before low to stop on low
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
open-label cross-over RCT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood ketones > 0.6mmol/l. | 4 weeks | ketonaemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean time of suspension of insulin delivery | 4 weeks | — |
| frequency of hospitalization due to ketonaemia | 4 weeks | — |
| mean glucose based on CGM | 4 weeks | — |
| time >140 mg/dl | 4 weeks | — |
| time >180 mg/dl | 4 weeks | — |
| time <63 mg/dl | 4 weeks | — |
| time <50mg/dl | 4 weeks | — |
| mean concentration of blood ketones | 4 weeks | — |
| standard deviation of glycaemic measurements | 4 weeks | — |
| mean amplitude of glucose excursions | 4 weeks | — |
| HbA1c | 4 weeks | — |
| time 70-180 mg/dL | 4 weeks | — |
| frequency of CGM use >80% of time | 4 weeks | CGM compliance |
| 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 |
| coefficient of variation of glycaemic measurements | 4 weeks | — |
Countries
Belgium
Outcome results
None listed