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
- Conditions
- Type 1 Diabetes
- Interventions
- Device: Abbott Diabetes CareDevice: Guardian Connect, Medtronic
- Registration Number
- NCT04249102
- Lead Sponsor
- Queen Fabiola Children's University Hospital
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- Subject with mental disability
- Previous use of Continuous Glucose Monitoring system
- Subject currently participating to another clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FGM Group Abbott Diabetes Care The control group will be provided with a Flash Glucose Monitoring system (Abbott Diabetes Care). CGM Group Guardian Connect, Medtronic The study group will be provided with a Continuous Glucose Monitoring system (Guardian Connect from Medtronic).
- Primary Outcome Measures
Name Time Method To evaluate the change in baseline hypoglycemia after 8-week Continuous Glucose Monitoring system use At Baseline and after 8 weeks of Continuous Glucose Monitoring system use % of Time-Below-Range (i.e. \< 70 mg/dl)
- Secondary Outcome Measures
Name Time Method 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. At baseline and after 8 weeks of Continuous Glucose Monitoring system use HbA1c value in %
To evaluate the change in severe hypoglycemia frequency in patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system. At baseline and after 8 weeks of Continuous Glucose Monitoring system use Number of severe hypoglycaemia (i.e. hypoglycemic event leading leading to loss of consciousness)
To evaluate the change in the quality of life of patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system. At baseline and after 8 weeks of Continuous Glucose Monitoring system use EQ-5D-3L Questionnaire
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. At baseline and after 8 weeks of Continuous Glucose Monitoring system use Number of severe hypoglycaemia (i.e. hypoglycemic event leading leading to loss of consciousness)
To evaluate the change in HbA1c in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system. At baseline and after 8 weeks of Continuous Glucose Monitoring system use HbA1c value in %
To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system. At baseline and after 8 weeks of Continuous Glucose Monitoring system use low blood glucose index
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. At baseline and after 8 weeks of Continuous Glucose Monitoring system use low blood glucose index
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. At baseline and after 8 weeks of Continuous Glucose Monitoring system use EQ-5D-3L Questionnaire
Trial Locations
- Locations (1)
Hôpital Universitaire Des Enfants Reine Fabiola
🇧🇪Brussels, Belgium