Prospective Randomized Clinical Trial Assessing the Short Term Clinical Impact of Continuous vs Flash Glucose Monitoring in Children, Adolescents and Young Adults With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— GluMoCAY  

Official title:

Prospective Randomized Clinical Study Assessing the Clinical Impact of Continuous vs Flash Glucose Monitoring During a 8 Weeks Period in Children, Adolescents and Young Adults 4 to 20 Years Old With Type 1 Diabetes Previously Using Flash Glucose Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249102
• Other study ID #: CGM2020/1
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: February 2022

Study information

• Verified date: January 2020
• Source: Queen Fabiola Children's University Hospital
• Contact: Anissa Messaaoui, MD
• Phone: +32.2.477.33.84
• Email: anissa.messaaoui[@]huderf.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Impaired hypoglycemia awareness, a significant problem for children with type 1 diabetes, is defined as neurogenic symptom response before autonomic response to hypoglycemia. Avoiding hypoglycemia appears to restore hypoglycemia awareness.

Investigators have previously demonstrated in a retrospective study that Flash Glucose Monitoring system decreased the risk of severe hypoglycemia in type 1 diabetic children and adolescents, even though Flash Glucose Monitoring system, unlike Continuous Glucose Monitoring system, does not provide glucose alerts.

Continuous Glucose Monitoring system, by providing real-time data with alarms, could benefit to subjects still experiencing severe hypoglycemia with Flash Glucose Monitoring system. Besides, in adults, Continuous Glucose Monitoring system reduced more effectively impaired hypoglycemia awareness compared to Flash Glucose Monitoring system.

In that context, investigators would like to assess the impact of Continuous Glucose Monitoring system instead of Flash Glucose Monitoring system on hypoglycemia in children and adolescents with type 1 diabetes.

Description:

All subjects will start with a 7 days run-in phase using their current Flash Glucose Monitoring System associated with a blind Continuous Glucose Monitoring system (Envision, Medtronic).

After one week, subjects randomized in the the interventional group will be provided with the Continuous Glucose Monitoring (Guardian Connect, Medtronic) and trained by dedicated diabetes educators for Continuous Glucose Monitoring usage including insertion of the sensor, calibration of the device twice daily and interpretation of the data. Subjects will use the sensors according to the license.

For both groups, insulin doses decisions are made by the participant according the received education.

After one week, all subjects will be contacted by phone focusing on the use of the technology. The treatment period is 8 weeks. The last week of the treatment period, subjects will use the blind Continuous Glucose Monitoring system (Envision, Medtronic) in addition to their allocated Glucose Monitoring system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 20 Years

Eligibility

Inclusion Criteria:

• Male and female aged from 4 to 20 years

• Subjects with onset of diabetes before 16 years of age

• Diabetes duration of more than 1 year

• Subject currently using Flash Glucose Monitoring system in daily practice

Exclusion Criteria:

• Subject with mental disability

• Previous use of Continuous Glucose Monitoring system

• Subject currently participating to another clinical study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Guardian Connect, Medtronic
Guardian Connect is real-time continuous glucose sensor systems which provide glucose information updated every 5 minutes
• Abbott Diabetes Care
Abbott Diabetes Care is a Flash Glucose Monitoring system that provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor.

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the change in baseline hypoglycemia after 8-week Continuous Glucose Monitoring system use	% of Time-Below-Range (i.e. < 70 mg/dl)	At Baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in severe hypoglycemia frequency in patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	Number of severe hypoglycaemia (i.e. hypoglycemic event leading leading to loss of consciousness)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in HbA1c in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	HbA1c value in %	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	% of time spent in the target range (70 - 180 mg/dl)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	% of time spent above the target range (> 180 mg/dl and > 250 mg/dl)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	% of time spent below the target range (< 70 mg/dl and < 54 mg/dl)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	Coefficient of variation (SD/Mean)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	low blood glucose index	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in the quality of life of patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	EQ-5D-3L Questionnaire	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in severe hypoglycemia frequency in patients with and without impaired hypoglycemia awareness using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	Number of severe hypoglycaemia (i.e. hypoglycemic event leading leading to loss of consciousness)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in HbA1c in patients with and without impaired hypoglycemia awareness using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	HbA1c value in %	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To assess the change in glycemic variability in patients with and without impaired hypoglycemia awareness using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	% of time spent in the target range (70 - 180 mg/dl)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To assess the change in glycemic variability in patients with and without impaired hypoglycemia awareness using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	% of time spent above the target range (> 180 mg/dl and > 250 mg/dl)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To assess the change in glycemic variability in patients with and without impaired hypoglycemia awareness using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	% of time spent below the target range (< 70 mg/dl and < 54 mg/dl)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To assess the change in glycemic variability in patients with and without impaired hypoglycemia awareness using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	Coefficient of variation (SD/Mean)	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To assess the change in glycemic variability in patients with and without impaired hypoglycemia awareness using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	low blood glucose index	At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary	To evaluate the change in the quality of life of patients with and without impaired hypoglycemia awareness using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.	EQ-5D-3L Questionnaire	At baseline and after 8 weeks of Continuous Glucose Monitoring system use