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

NCT04249102 | Unknown

• 1 other identifier: CGM2020/1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• To evaluate the change in baseline hypoglycemia after 8-week 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 Outcomes (16)

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

  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.

  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.

  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.

  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.

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

Study Arms (2)

CGM Group

EXPERIMENTAL

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

Device: Guardian Connect, Medtronic

FGM Group

ACTIVE COMPARATOR

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

Device: Abbott Diabetes Care

Interventions

Guardian Connect, Medtronic DEVICE

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

CGM Group

Abbott Diabetes Care DEVICE

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.

FGM Group

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Queen Fabiola Children's University Hospital: lead

Study Sites (1)

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 35870074 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anissa Messaaoui, MD

  Queen Fabiola Children's University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anissa Messaaoui, MD

CONTACT

+32.2.477.33.84; anissa.messaaoui@huderf.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 30, 2020
• Study Start: March 12, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)