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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)

Primary Purpose

Type 1 Diabetes

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Guardian Connect, Medtronic

Abbott Diabetes Care

About this trial

This is an interventional diagnostic trial for Type 1 Diabetes

Eligibility Criteria

4 Years - 20 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Hôpital Universitaire Des Enfants Reine FabiolaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CGM Group

FGM Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

To evaluate the change in baseline hypoglycemia after 8-week Continuous Glucose Monitoring system use

% of Time-Below-Range (i.e. < 70 mg/dl)

Secondary Outcome Measures

To evaluate the change in severe hypoglycemia frequency in patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.

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.

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.

% of time spent in the target range (70 - 180 mg/dl)

To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.

% of time spent above the target range (> 180 mg/dl and > 250 mg/dl)

To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.

% of time spent below the target range (< 70 mg/dl and < 54 mg/dl)

To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.

Coefficient of variation (SD/Mean)

To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.

low blood glucose index

To evaluate the change in the quality of life of patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.

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.

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.

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.

% of time spent in the target range (70 - 180 mg/dl)

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.

% of time spent above the target range (> 180 mg/dl and > 250 mg/dl)

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.

% of time spent below the target range (< 70 mg/dl and < 54 mg/dl)

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.

Coefficient of variation (SD/Mean)

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.

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.

EQ-5D-3L Questionnaire

Full Information

NCT ID

NCT04249102

First Posted

January 23, 2020

Last Updated

March 30, 2020

Sponsor

Queen Fabiola Children's University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04249102

Brief Title

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

Acronym

GluMoCAY

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 12, 2020 (Actual)

Primary Completion Date

February 2022 (Anticipated)

Study Completion Date

February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Queen Fabiola Children's University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CGM Group

Arm Type

Experimental

Arm Description

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

Arm Title

FGM Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Guardian Connect, Medtronic

Intervention Description

Guardian Connect is real-time continuous glucose sensor systems which provide glucose information updated every 5 minutes

Intervention Type

Device

Intervention Name(s)

Abbott Diabetes Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

To evaluate the change in baseline hypoglycemia after 8-week Continuous Glucose Monitoring system use

Description

% of Time-Below-Range (i.e. < 70 mg/dl)

Time Frame

At Baseline and after 8 weeks of Continuous Glucose Monitoring system use

Secondary Outcome Measure Information:

Title

To evaluate the change in severe hypoglycemia frequency in patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.

Description

Number of severe hypoglycaemia (i.e. hypoglycemic event leading leading to loss of consciousness)

Time Frame