Type 1 Diabetes
Conditions
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.
Interventions
DEVICEGuardian Connect, Medtronic
Guardian Connect is real-time continuous glucose sensor systems which provide glucose information updated every 5 minutes
DEVICEAbbott 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.
Sponsors
Queen Fabiola Children's University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Subjects will be randomized in a 1:1 ratio either in the control group (Flash Glucose Monitoring system) or in the investigational group (Continuous Glucose Monitoring system). Randomization will be stratified according to the subject impaired hypoglycaemia awareness score (\< 4 vs ≥ 4)
Eligibility
Sex/Gender
ALL
Age
4 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | % of time spent in the target range (70 - 180 mg/dl) |
| 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 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 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 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 | % of time spent in the target range (70 - 180 mg/dl) |
| 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 |
| 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) |
Countries
Belgium
Contacts
Primary ContactAnissa Messaaoui, MD
Outcome results
None listed