Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (The CGM TIME Trial)
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|ClinicalTrials.gov Identifier: NCT01295788|
Recruitment Status : Unknown
Verified July 2017 by Margaret Lawson, Children's Hospital of Eastern Ontario.
Recruitment status was: Active, not recruiting
First Posted : February 15, 2011
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: Simultaneous RT-CGM and Pump Initiation Device: Delayed Initiation of RT-CGM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Simultaneous or Delayed initiation of continuous glucose monitoring|
|Masking:||None (Open Label)|
|Official Title:||Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy|
|Actual Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||December 2017|
Experimental: Simultaneous RT-CGM and Pump Initiation
The experimental group will initiate RT-CGM at the same time as they begin insulin pump therapy.
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.
Other Name: Sensor-Augmented Pump Therapy at Pump Initiation
Active Comparator: Delayed RT-CGM Initiation
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
Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy.
- Adherence to CGM (hours per week) [ Time Frame: one year ]Number of hours of RT-CGM use per week
- A1C [ Time Frame: one year ]Hemoglobin A1C
- Readiness for change [ Time Frame: six months ]SOCRATES - Diabetes Version
- Treatment Satisfaction and Quality of Life [ Time Frame: one year ]Insulin Delivery Systems Rating Questionnaire (IDSRQ)
- Fear of Hypoglycemia [ Time Frame: one year ]Hypoglycemia Fear Scale (HFS-98)
- Barriers to Adherence [ Time Frame: one year ]Modified Barriers to Adherence Questionnaire (MBAQ)
- Perception of Barriers/Facilitators to RT-CGM Use [ Time Frame: one year ]CGM Satisfaction Scale (CGM-SAT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295788
|McMaster Children's Hospital|
|Hamilton, Ontario, Canada, L8S 4J9|
|Children's Hospital of Western Ontario|
|London, Ontario, Canada, N5Y 3T2|
|Markham, Ontario, Canada, L3P 7P3|
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Study Director:||Margaret L Lawson, MD||Children's Hospital of Eastern Ontario|