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

This study is currently recruiting participants.
Verified November 2011 by Children's Hospital of Eastern Ontario
Sponsor:
Collaborator:
JDRF Canadian Clinical Trial Network
Information provided by (Responsible Party):
Margaret Lawson, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT01295788
First received: February 14, 2011
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
 Device: Simultaneous RT-CGM and Pump Initiation
Device: Delayed Initiation of RT-CGM
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Adherence to CGM (hours per week) [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of hours of RT-CGM use per week


Secondary Outcome Measures:
  • A1C [ Time Frame: one year ] [ Designated as safety issue: No ]
    Hemoglobin A1C

  • Readiness for change [ Time Frame: six months ] [ Designated as safety issue: No ]
    SOCRATES - Diabetes Version

  • Treatment Satisfaction and Quality of Life [ Time Frame: one year ] [ Designated as safety issue: No ]
    Insulin Delivery Systems Rating Questionnaire (IDSRQ)

  • Fear of Hypoglycemia [ Time Frame: one year ] [ Designated as safety issue: No ]
    Hypoglycemia Fear Scale (HFS-98)

  • Barriers to Adherence [ Time Frame: one year ] [ Designated as safety issue: No ]
    Modified Barriers to Adherence Questionnaire (MBAQ)

  • Perception of Barriers/Facilitators to RT-CGM Use [ Time Frame: one year ] [ Designated as safety issue: No ]
    CGM Satisfaction Scale (CGM-SAT)


Estimated Enrollment: 128
Study Start Date: June 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295788

Contacts
Contact: Margaret L Lawson, MD 613-737-7600 ext 2113 lawson@cheo.on.ca

Locations
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8S 4J9
Contact: Tamara Caceres     905-521-2100 ext 76055     tcacere@gmail.com    
Contact: Janice Muileboom, RN, CDE     905-521-2100 ext 73236     muileboom@hhsc.ca    
Principal Investigator: Karen McAssey, MD            
Children's Hospital of Western Ontario Recruiting
London, Ontario, Canada, N5Y 3T2
Contact: Margaret Watson, RN     519-685-8500 ext 56111     margaret.watson@lhsc.on.ca    
Contact: Ruth Duncan, RN, CDE     519-685-8500 ext 52896     ruth.duncan@lhsc.on.ca    
Principal Investigator: Cheril Clarson, MD            
Sub-Investigator: Patricia Gallego, MD            
Sub-Investigator: Robbie Stein, MD            
Markham-Stouffville Hospital Recruiting
Markham, Ontario, Canada, L3P 7P3
Contact: Sameer Datwani     905-472-7373 ext 6043     SDatwani@msh.on.ca    
Contact: Alanna Landry, RN, CDE     905-472-7373 ext 6053     alandry@msh.on.ca    
Principal Investigator: Susan Greenberg, MD            
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jennilea Courtney     613-737-7600 ext 4156     jcourtney@cheo.on.ca    
Contact: Brenda Bradley, RN     613-737-7600 ext 3055     bbradley@cheo.on.ca    
Principal Investigator: Margaret L Lawson, MD            
Sub-Investigator: Radmila Jovanovic, MD            
Sub-Investigator: Alexandra Ahmet, MD            
Sub-Investigator: Sarah Lawrence, MD            
Sub-Investigator: Ellen Goldbloom, MD            
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Jolie Davies-Shaw     416-813-7654     jolie.davies-shaw@sickkids.ca    
Contact: Lynne Cormack, RN, CDE     416-813-5838 ext 6     lynne.cormack@sickkids.ca    
Principal Investigator: Jacqueline Curtis, MD            
Sub-Investigator: Farid Mahmud, MD            
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
JDRF Canadian Clinical Trial Network
Investigators
Study Director: Margaret L Lawson, MD Children's Hospital of Eastern Ontario
  More Information

Additional Information:
JDRF Canadian Clinical Trial Network  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Margaret Lawson, Associate Professor, Pediatrics, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01295788     History of Changes
Other Study ID Numbers: CHEO 09/05E
Study First Received: February 14, 2011
Last Updated: November 1, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013