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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Pregnant Women With Type 1 Diabetes

Treatments: Device: SAP with stop on low; Device: SAP with stop before low

Study type: Interventional

Funder types: Other

Identifiers

NCT04292509

ROKSANA study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

SAP with predictive stop before low

Experimental group

Description:

Sensor-augmented pump therapy with the use of the predictive stop before low mode of action

Treatment:

Device: SAP with stop before low

SAP with stop on low

Active Comparator group

Description:

Sensor-augmented pump therapy with the use of the predictive stop on low mode of action

Treatment:

Device: SAP with stop on low