Type 1 DiabetesGluMoCAYNCT04249102

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

A study testing Guardian Connect, Medtronic and Abbott Diabetes Care in people with Type 1 Diabetes, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 4 to 20 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Guardian Connect, Medtronic and Abbott Diabetes Care
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteBelgium
Study dates: 12 Mar 2020to Feb 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

Subject with mental disability
Previous use of Continuous Glucose Monitoring system
Subject currently participating to another clinical study

Trial locations and contacts

1 site in 1 country.

Anissa Messaaoui, MD contact

+32.2.477.33.84

anissa.messaaoui@huderf.be

Belgium1 site, 1 recruiting

Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020
Anissa Messaaoui, MD, +32.2.477.33.84, Anissa.messaaoui@huderf.be
Anissa Messaaoui, MD
Recruiting

Other trials in Belgium

About this study

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

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.

Read the 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.

Conditions: Type 1 Diabetes
Being tested: Guardian Connect, Medtronic, Abbott Diabetes Care
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Guardian Connect, MedtronicDevice
Guardian Connect is real-time continuous glucose sensor systems which provide glucose information updated every 5 minutes
Abbott Diabetes CareDevice
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.

Study groups in NCT04249102
Study group	Role	What they receive
CGM Group	Experimental	The study group will be provided with a Continuous Glucose Monitoring system (Guardian Connect from Medtronic). Receives: Device: Guardian Connect, Medtronic
FGM Group	Active comparator	The control group will be provided with a Flash Glucose Monitoring system (Abbott Diabetes Care). Receives: Device: Abbott Diabetes Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (16)

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)
Measured: 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.
HbA1c value in %
Measured: 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.
% of time spent in the target range (70 - 180 mg/dl)
Measured: 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.
% of time spent above the target range (> 180 mg/dl and > 250 mg/dl)
Measured: 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.
% of time spent below the target range (< 70 mg/dl and < 54 mg/dl)
Measured: 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.
Coefficient of variation (SD/Mean)
Measured: 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.
low blood glucose index
Measured: 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.
EQ-5D-3L Questionnaire
Measured: 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.
Number of severe hypoglycaemia (i.e. hypoglycemic event leading leading to loss of consciousness)
Measured: 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.
HbA1c value in %
Measured: 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.
% of time spent in the target range (70 - 180 mg/dl)
Measured: 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.
% of time spent above the target range (> 180 mg/dl and > 250 mg/dl)
Measured: 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.
% of time spent below the target range (< 70 mg/dl and < 54 mg/dl)
Measured: 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.
Coefficient of variation (SD/Mean)
Measured: 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.
low blood glucose index
Measured: 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.
EQ-5D-3L Questionnaire
Measured: At baseline and after 8 weeks of Continuous Glucose Monitoring system use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 2020Feb 2022

First posted30 Jan 2020
Study start12 Mar 2020
Primary completionFeb 2022 (estimated)
Study completionFeb 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04249102
Sponsor's protocol ID: CGM2020/1
Acronym: GluMoCAY
Status last verified: Jan 2020
First submitted: 23 Jan 2020
Last updated: 31 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35870074

Want to know more?

Anissa Messaaoui, MD

+32.2.477.33.84

anissa.messaaoui@huderf.be

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04249102
Acronym / sponsor ID: GluMoCAY / CGM2020/1
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Queen Fabiola Children's University HospitalUniversity, hospital or other
Study start: 12 Mar 2020 (actual)
Primary completion: Feb 2022 (estimated)
Study completion: Feb 2022 (estimated)
First posted: 30 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

For both groups, insulin doses decisions are made by the participant according the received education.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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)

Arm	Type	Receives
CGM Group	Experimental	Device: Guardian Connect, MedtronicThe study group will be provided with a Continuous Glucose Monitoring system (Guardian Connect from Medtronic).
FGM Group	Active comparator	Device: Abbott Diabetes CareThe control group will be provided with a Flash Glucose Monitoring system (Abbott Diabetes Care).

Who may qualify

Ages: 4 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Subject with mental disability
Previous use of Continuous Glucose Monitoring system
Subject currently participating to another clinical study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Guardian Connect, MedtronicGuardian Connect is real-time continuous glucose sensor systems which provide glucose information updated every 5 minutes	Device	CGM Group
Abbott Diabetes CareAbbott 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.	Device	FGM Group

Primary outcome

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)

16 secondary outcomes

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Derived from this study: PubMed 35870074Messaaoui 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.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes

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Continuous Glucose Monitoring, Type 1 Diabetes
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A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anissa Messaaoui, MD contact

+32.2.477.33.84

anissa.messaaoui@huderf.be

Anissa Messaaoui, MD principal investigator

Queen Fabiola Children's University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Guardian Connect, Medtronic and Abbott Diabetes Care in people with Type 1 Diabetes, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anissa Messaaoui, MD (+32.2.477.33.84, anissa.messaaoui@huderf.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04249102, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.