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

Pregnant Women With Type 1 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292509
• Other study ID #: ROKSANA study
• Status: Completed
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: September 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes, Gestational
• Pregnancy in Diabetics
• Pregnant Women With Type 1 Diabetes

Intervention

Device:
• SAP with stop before low
cross-over comparison from stop on low to stop before low
• SAP with stop on low
cross-over comparison from stop before low to stop on low

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood ketones > 0.6mmol/l.	ketonaemia	4 weeks
Secondary	mean concentration of blood ketones		4 weeks
Secondary	mean time of suspension of insulin delivery		4 weeks
Secondary	frequency of hospitalization due to ketonaemia		4 weeks
Secondary	mean glucose based on CGM		4 weeks
Secondary	time >140 mg/dl		4 weeks
Secondary	time >180 mg/dl		4 weeks
Secondary	time <63 mg/dl		4 weeks
Secondary	time <50mg/dl		4 weeks
Secondary	coefficient of variation of glycaemic measurements		4 weeks
Secondary	standard deviation of glycaemic measurements		4 weeks
Secondary	mean amplitude of glucose excursions		4 weeks
Secondary	HbA1c		4 weeks
Secondary	time 70-180 mg/dL		4 weeks
Secondary	frequency of CGM use >80% of time	CGM compliance	4 weeks
Secondary	total insulin dose		4 weeks
Secondary	severe hypoglycemic episodes	defined as requiring third-party assistance and/or capillary glucose <50 mg/dL associated with clinical symptoms	4 weeks