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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Delayed Initiation of RT-CGM; Device: Simultaneous RT-CGM and Pump Initiation

• 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.

Study Timeline

• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Study Start: 2011-05
• Primary Completion: 2014-06
• Study Completion: 2017-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-02

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

Arm && Interventions

Group	Intervention	Description
Delayed RT-CGM Initiation	Delayed Initiation of RT-CGM	The control group will use standard pump therapy until the 6 month study visit at which time RT-CGM will be initiated.
Simultaneous RT-CGM and Pump Initiation	Simultaneous RT-CGM and Pump Initiation	The experimental group will initiate RT-CGM at the same time as they begin insulin pump therapy.

Primary Outcome Measures

Name	Time	Method
Adherence to CGM (hours per week)	one year	Number of hours of RT-CGM use per week

Secondary Outcome Measures

Name	Time	Method
A1C	one year	Hemoglobin A1C
Readiness for change	six months	SOCRATES - Diabetes Version
Treatment Satisfaction and Quality of Life	one year	Insulin Delivery Systems Rating Questionnaire (IDSRQ)
Perception of Barriers/Facilitators to RT-CGM Use	one year	CGM Satisfaction Scale (CGM-SAT)
Barriers to Adherence	one year	Modified Barriers to Adherence Questionnaire (MBAQ)
Fear of Hypoglycemia	one year	Hypoglycemia Fear Scale (HFS-98)

Trial Locations

Locations (5)

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

Children's Hospital of Western Ontario; 🇨🇦 London, Ontario, Canada

Markham-Stouffville Hospital; 🇨🇦 Markham, Ontario, Canada

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

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada