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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Simultaneous RT-CGM and Pump Initiation
* Device: Delayed Initiation of RT-CGM


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Males and females age 5-18 years old. Established T1D diagnosis for a minimum of one year. Naïve to CSII therapy and ready to start CSII with the Veo pump (Medtronic) . Willing to use RT-CGM and to be randomly assigned to either simultaneous or delayed RT-CGM initiation. Regular diabetes follow up at one of the 5 participating sites. Internet access at home (to upload RT-CGM data). Parent(s) or legally acceptable representative able to speak and read English or French. Ability of the subject and parent(s) or legally acceptable representative to participate in all aspects of this clinical trial. Written informed consent must be obtained and documented, with assent of the child if <14 years of age. Exclusion Criteria Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study. Has received oral and/or intravenous steroid therapy (for any indication, at any dose and/or for any duration) on more than 2 separate occasions in the past 12 months. Use of inhaled and/or topical steroid therapy in the last 12 months does not exclude the subject. Prior use of RT-CGM for more than 50% of the time over the past 6 months. Prior enrollment in the current study. Current enrollment in another intervention trial.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Simultaneous or Delayed initiation of continuous glucose monitoring
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simultaneous RT-CGM and Pump Initiation<br>The experimental group will initiate RT-CGM at the same time as they begin insulin pump therapy. | Device: Simultaneous RT-CGM and Pump Initiation<br>* Subjects in this group will start using RT-CGM at the same time as they initiate insulin pump therapy.<br>* Other names: Sensor-Augmented Pump Therapy at Pump Initiation;|
| Active Comparator: Delayed RT-CGM Initiation<br>The control group will use standard pump therapy until the 6 month study visit at which time RT-CGM will be initiated. | Device: Delayed Initiation of RT-CGM<br>* Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to CGM (hours per week) | Number of hours of RT-CGM use per week | one year | 

Secondary Outcome Measures

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