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)

March 30, 2020 updated by: Queen Fabiola Children's University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Recruiting
        • Hôpital Universitaire Des Enfants Reine Fabiola
        • Contact:
        • Principal Investigator:
          • Anissa Messaaoui, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGM Group
The study group will be provided with a Continuous Glucose Monitoring system (Guardian Connect from Medtronic).
Device: Guardian Connect, Medtronic
Guardian Connect is real-time continuous glucose sensor systems which provide glucose information updated every 5 minutes
Active Comparator: FGM Group
The control group will be provided with a Flash Glucose Monitoring system (Abbott Diabetes Care).
Device: Abbott 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the change in baseline hypoglycemia after 8-week Continuous Glucose Monitoring system use
Time Frame: At Baseline and after 8 weeks of Continuous Glucose Monitoring system use
% of Time-Below-Range (i.e. < 70 mg/dl)
At Baseline and after 8 weeks of Continuous Glucose Monitoring system use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the change in severe hypoglycemia frequency in patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
Time Frame: 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)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
To evaluate the change in HbA1c in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
HbA1c value in %
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
% of time spent in the target range (70 - 180 mg/dl)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
% of time spent above the target range (> 180 mg/dl and > 250 mg/dl)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
% of time spent below the target range (< 70 mg/dl and < 54 mg/dl)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Coefficient of variation (SD/Mean)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
To evaluate the change in glycemic variability in patients monitored with Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
low blood glucose index
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
To evaluate the change in the quality of life of patients using Continuous Glucose Monitoring system in comparison to Flash Glucose Monitoring system.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
EQ-5D-3L Questionnaire
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
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.
Time Frame: 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)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
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.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
HbA1c value in %
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
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.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
% of time spent in the target range (70 - 180 mg/dl)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
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.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
% of time spent above the target range (> 180 mg/dl and > 250 mg/dl)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
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.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
% of time spent below the target range (< 70 mg/dl and < 54 mg/dl)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
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.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
Coefficient of variation (SD/Mean)
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
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.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
low blood glucose index
At baseline and after 8 weeks of Continuous Glucose Monitoring system use
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.
Time Frame: At baseline and after 8 weeks of Continuous Glucose Monitoring system use
EQ-5D-3L Questionnaire
At baseline and after 8 weeks of Continuous Glucose Monitoring system use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Fabiola Children's University Hospital

Investigators

  • Principal Investigator: Anissa Messaaoui, MD, Queen Fabiola Children's University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2020

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGM2020/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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