Clinical trial NCT04249102: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the change in baseline hypoglycemia after 8-week Continuous Glucose Monitoring system use
timeFrame: At Baseline and after 8 weeks of Continuous Glucose Monitoring system use
Secondary outcomes:
measure: To evaluate the change in severe hypoglycemia frequency in patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: To evaluate the change in HbA1c in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: To evaluate the change in the quality of life of patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: 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.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: 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.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: 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.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: 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.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: 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.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: 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.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: 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.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
measure: 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.
timeFrame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire Des Enfants Reine Fabiola
Study officials:
affiliation: Queen Fabiola Children's University Hospital
name: Anissa Messaaoui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Messaaoui A, Tenoutasse S, Hajselova L, Crenier L. Comparison Between Continuous Versus Flash Glucose Monitoring in Children, Adolescents, and Young Adults with Type 1 Diabetes: An 8-Week Prospective Randomized Trial. Diabetes Ther. 2022 Sep;13(9):1671-1681. doi: 10.1007/s13300-022-01297-x. Epub 2022 Jul 23.