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
NCT ID: NCT04249102
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2020-03-12
2022-02-28
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
Randomization will be stratified according to the subject impaired hypoglycaemia awareness score (\< 4 vs ≥ 4)
DIAGNOSTIC
NONE
Study Groups
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CGM Group
The study group will be provided with a Continuous Glucose Monitoring system (Guardian Connect from Medtronic).
Guardian Connect, Medtronic
Guardian Connect is real-time continuous glucose sensor systems which provide glucose information updated every 5 minutes
FGM Group
The control group will be provided with a Flash Glucose Monitoring system (Abbott Diabetes Care).
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.
Interventions
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Guardian Connect, Medtronic
Guardian Connect is real-time continuous glucose sensor systems which provide glucose information updated every 5 minutes
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous use of Continuous Glucose Monitoring system
* Subject currently participating to another clinical study
4 Years
20 Years
ALL
No
Sponsors
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Queen Fabiola Children's University Hospital
OTHER
Responsible Party
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Principal Investigators
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Anissa Messaaoui, MD
Role: PRINCIPAL_INVESTIGATOR
Queen Fabiola Children's University Hospital
Locations
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Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Anissa Messaaoui, MD
Role: primary
References
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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.
Other Identifiers
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CGM2020/1
Identifier Type: -
Identifier Source: org_study_id