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

Primary Purpose

Pregnant Women With Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SAP with stop before low
SAP with stop on low
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pregnant Women With Type 1 Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAP with predictive stop before low

SAP with stop on low

Arm Description

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

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

Outcomes

Primary Outcome Measures

blood ketones > 0.6mmol/l.
ketonaemia

Secondary Outcome Measures

mean concentration of blood ketones
mean time of suspension of insulin delivery
frequency of hospitalization due to ketonaemia
mean glucose based on CGM
time >140 mg/dl
time >180 mg/dl
time <63 mg/dl
time <50mg/dl
coefficient of variation of glycaemic measurements
standard deviation of glycaemic measurements
mean amplitude of glucose excursions
HbA1c
time 70-180 mg/dL
frequency of CGM use >80% of time
CGM compliance
total insulin dose
severe hypoglycemic episodes
defined as requiring third-party assistance and/or capillary glucose <50 mg/dL associated with clinical symptoms

Full Information

First Posted
February 25, 2020
Last Updated
September 29, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04292509
Brief Title
Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy
Acronym
ROKSANA
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women With Type 1 Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
open-label cross-over RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAP with predictive stop before low
Arm Type
Experimental
Arm Description
Sensor-augmented pump therapy with the use of the predictive stop before low mode of action
Arm Title
SAP with stop on low
Arm Type
Active Comparator
Arm Description
Sensor-augmented pump therapy with the use of the predictive stop on low mode of action
Intervention Type
Device
Intervention Name(s)
SAP with stop before low
Intervention Description
cross-over comparison from stop on low to stop before low
Intervention Type
Device
Intervention Name(s)
SAP with stop on low
Intervention Description
cross-over comparison from stop before low to stop on low
Primary Outcome Measure Information:
Title
blood ketones > 0.6mmol/l.
Description
ketonaemia
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
mean concentration of blood ketones
Time Frame
4 weeks
Title
mean time of suspension of insulin delivery
Time Frame
4 weeks
Title
frequency of hospitalization due to ketonaemia
Time Frame
4 weeks
Title
mean glucose based on CGM
Time Frame
4 weeks
Title
time >140 mg/dl
Time Frame
4 weeks
Title
time >180 mg/dl
Time Frame
4 weeks
Title
time <63 mg/dl
Time Frame
4 weeks
Title
time <50mg/dl
Time Frame
4 weeks
Title
coefficient of variation of glycaemic measurements
Time Frame
4 weeks
Title
standard deviation of glycaemic measurements
Time Frame
4 weeks
Title
mean amplitude of glucose excursions
Time Frame
4 weeks
Title
HbA1c
Time Frame
4 weeks
Title
time 70-180 mg/dL
Time Frame
4 weeks
Title
frequency of CGM use >80% of time
Description
CGM compliance
Time Frame
4 weeks
Title
total insulin dose
Time Frame
4 weeks
Title
severe hypoglycemic episodes
Description
defined as requiring third-party assistance and/or capillary glucose <50 mg/dL associated with clinical symptoms
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrien Benhalima, MD PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34647140
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.
Results Reference
derived

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

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