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OpenTrials
Completed

NCT Number: NCT04292509

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

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.

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Key information

Conditions

Pregnant Women With Type 1 Diabetes

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAP with stop before low

Device

cross-over comparison from stop on low to stop before low

SAP with stop on low

Device

cross-over comparison from stop before low to stop on low

Primary outcomes

  1. blood ketones > 0.6mmol/l.

    Time frame: 4 weeks

    ketonaemia

Secondary outcomes

  1. mean concentration of blood ketones

    Time frame: 4 weeks

  2. mean time of suspension of insulin delivery

    Time frame: 4 weeks

  3. frequency of hospitalization due to ketonaemia

    Time frame: 4 weeks

  4. mean glucose based on CGM

    Time frame: 4 weeks

  5. time >140 mg/dl

    Time frame: 4 weeks

  6. time >180 mg/dl

    Time frame: 4 weeks

  7. time <63 mg/dl

    Time frame: 4 weeks

  8. time <50mg/dl

    Time frame: 4 weeks

  9. coefficient of variation of glycaemic measurements

    Time frame: 4 weeks

  10. standard deviation of glycaemic measurements

    Time frame: 4 weeks

  11. mean amplitude of glucose excursions

    Time frame: 4 weeks

  12. HbA1c

    Time frame: 4 weeks

  13. time 70-180 mg/dL

    Time frame: 4 weeks

  14. frequency of CGM use >80% of time

    Time frame: 4 weeks

    CGM compliance

  15. total insulin dose

    Time frame: 4 weeks

  16. severe hypoglycemic episodes

    Time frame: 4 weeks

    defined as requiring third-party assistance and/or capillary glucose <50 mg/dL associated with clinical symptoms

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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

Acronym: ROKSANA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2020
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.