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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnant Women With Type 1 Diabetes
• Intervention / Treatment: Device: SAP with stop before low; Device: SAP with stop on low

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAP with predictive stop before low; Sensor-augmented pump therapy with the use of the predictive stop before low mode of action	Device: SAP with stop before low; cross-over comparison from stop on low to stop before low
Active Comparator: SAP with stop on low; Sensor-augmented pump therapy with the use of the predictive stop on low mode of action	Device: SAP with stop on low; cross-over comparison from stop before low to stop on low

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood ketones > 0.6mmol/l.	ketonaemia	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean concentration of blood ketones		4 weeks
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
coefficient of variation of glycaemic measurements		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	CGM compliance	4 weeks
total insulin dose		4 weeks
severe hypoglycemic episodes	defined as requiring third-party assistance and/or capillary glucose <50 mg/dL associated with clinical symptoms	4 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Katrien Benhalima, MD PhD, UZ Leuven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: ROKSANA study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No