Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (The CGM TIME Trial)
NCT01295788 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2021-06-02
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.
Conditions
Interventions
- DEVICE
-
Simultaneous RT-CGM and Pump Initiation
Subjects in this group will start using RT-CGM at the same time as they initiate insulin pump therapy.
- DEVICE
-
Delayed Initiation of RT-CGM
Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy.
Sponsors & Collaborators
-
Juvenile Diabetes Research Foundation
collaborator OTHER -
Canadian Clinical Trial Network
collaborator UNKNOWN -
Children's Hospital of Eastern Ontario
lead OTHER
Principal Investigators
-
Margaret L Lawson, MD · Children's Hospital of Eastern Ontario
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-05-31
- Primary Completion
- 2014-06-30
- Completion
- 2017-12-31
Countries
- Canada
Study Locations
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