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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Recruiting
        • Hopital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen Fabiola Children's University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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