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Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (The CGM TIME Trial)

Not Applicable
Completed
Conditions
Type 1 Diabetes
Registration Number
NCT01295788
Lead Sponsor
Children's Hospital of Eastern Ontario
Brief Summary

The investigators hypothesize that REAL-Time Continuous Glucose Monitoring (RT-CGM) will be more effective if introduced in children and adolescents with established diabetes at the same time as they are starting pump therapy. This randomized controlled trial will compare the effectiveness of simultaneous vs delayed introduction of RT-CGM in children and adolescents with type 1 diabetes who are starting insulin pump therapy.

Detailed Description

REAL-Time Continuous Glucose Monitoring (RT-CGM) improves diabetes control in adults with type 1 diabetes. However, studies of RT-CGM in children and adolescents have been mostly negative. The lack of effectiveness in the pediatric population appears directly related to adherence to RT-CGM, i.e., the willingness of children and teens to wear and use this technology. Most previous RT-CGM studies have focused on experienced pump users or children with new-onset diabetes. At the time of pump initiation, children and adolescents who have been living with diabetes (and their parents) are highly motivated to make changes in their diabetes management and to take on additional responsibilities to improve their diabetes control and lifestyle, the two primary reasons for initiating pump therapy in the pediatric population. The investigators hypothesize that readiness for making changes in diabetes management will be greater at the time of pump initiation than at six months after the pump start. Further, the investigators hypothesize that readiness for change at the time of RT-CGM initiation will predict future adherence to RT-CGM and its effectiveness.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
144
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Adherence to CGM (hours per week)one year

Number of hours of RT-CGM use per week

Secondary Outcome Measures
NameTimeMethod
A1Cone year

Hemoglobin A1C

Treatment Satisfaction and Quality of Lifeone year

Insulin Delivery Systems Rating Questionnaire (IDSRQ)

Perception of Barriers/Facilitators to RT-CGM Useone year

CGM Satisfaction Scale (CGM-SAT)

Readiness for changesix months

SOCRATES - Diabetes Version

Barriers to Adherenceone year

Modified Barriers to Adherence Questionnaire (MBAQ)

Fear of Hypoglycemiaone year

Hypoglycemia Fear Scale (HFS-98)

Trial Locations

Locations (5)

McMaster Children's Hospital

🇨🇦

Hamilton, Ontario, Canada

Children's Hospital of Western Ontario

🇨🇦

London, Ontario, Canada

Markham-Stouffville Hospital

🇨🇦

Markham, Ontario, Canada

Children's Hospital of Eastern Ontario

🇨🇦

Ottawa, Ontario, Canada

Hospital for Sick Children

🇨🇦

Toronto, Ontario, Canada

McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada

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