Type 1 Diabetes Clinical Trial
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
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.
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.
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