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 (GluMoCAY)

Queen Fabiola Children's University Hospital

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Device: Abbott Diabetes Care; Device: Guardian Connect, Medtronic

Study type: Interventional

Funder types: Other

Identifiers

NCT04249102

CGM2020/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 4 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

CGM Group

Experimental group

Description:

The study group will be provided with a Continuous Glucose Monitoring system (Guardian Connect from Medtronic).

Treatment:

Device: Guardian Connect, Medtronic

FGM Group

Active Comparator group

Description:

The control group will be provided with a Flash Glucose Monitoring system (Abbott Diabetes Care).

Treatment:

Device: Abbott Diabetes Care