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

This study is ongoing, but not recruiting participants.
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: June 7, 2013
Last verified: June 2013

February 14, 2011
June 7, 2013
June 2011
July 2014   (final data collection date for primary outcome measure)
Adherence to CGM (hours per week) [ Time Frame: one year ] [ Designated as safety issue: No ]
Number of hours of RT-CGM use per week
Adherence to CGM (hours per week) [ Time Frame: 6 months after RT-CGM initiation ] [ Designated as safety issue: No ]
Number of hours of RT-CGM use per week
Complete list of historical versions of study NCT01295788 on ClinicalTrials.gov Archive Site
  • 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)
  • Barriers to Adherence [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Modified Barriers to Adherence Questionnaire (MBAQ)
  • Readiness for change [ Time Frame: 0 and 6 months ] [ Designated as safety issue: No ]
    SOCRATES - Diabetes Version
  • Treatment Satisfaction and Quality of Life [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Insulin Delivery Systems Rating Questionnaire (IDSRQ)
  • Fear of Hypoglycemia [ Time Frame: 0, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Hypoglycemia Fear Scale (HFS-98)
  • A1C [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    1. Mean change in A1C from baseline to 12 months in Simultaneous RT-CGM group compared to delayed RT-CGM group
    2. Proportion of subjects meeting ADA/CDA A1C targets for age at 12 months in Simultaneous RT-CGM group compared to delayed RT-CGM group
    3. Mean change in A1C from baseline to 6 months in Simultaneous RT-CGM group compared to delayed RT-CGM group (ie standard pump therapy)
    4. Proportion of subjects meeting ADA/CDA A1C targets for age at 6 months in Simultaneous RT-CGM group compared to delayed RT-CGM group (ie standard pump therapy)
  • Perception of Barriers/Facilitators to RT-CGM Use [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
    CGM Satisfaction Scale (CGM-SAT)
Not Provided
Not Provided
 
Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (The CGM TIME Trial)
Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
  • 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
  • Device: Delayed Initiation of RT-CGM
    Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy.
  • Experimental: Simultaneous RT-CGM and Pump Initiation
    The experimental group will initiate RT-CGM at the same time as they begin insulin pump therapy.
    Intervention: Device: Simultaneous RT-CGM and 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.
    Intervention: Device: Delayed Initiation of RT-CGM
Lawson ML, Bradley B, McAssey K, Clarson C, Kirsch SE, Mahmud FH, Curtis JR, Richardson C, Courtney J, Cooper T, Downie CJ, Rajamannar G, Barrowman N; CGM TIME Trial Study Group; JDRF Canadian Clinical Trial Network CCTN1101. The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: study protocol, recruitment and baseline characteristics. BMC Pediatr. 2014 Jul 18;14:183. doi: 10.1186/1471-2431-14-183.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
144
January 2015
July 2014   (final data collection date for primary outcome measure)

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.
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01295788
CHEO 09/05E
Yes
Margaret Lawson, Children's Hospital of Eastern Ontario
Children's Hospital of Eastern Ontario
JDRF Canadian Clinical Trial Network
Study Director: Margaret L Lawson, MD Children's Hospital of Eastern Ontario
Children's Hospital of Eastern Ontario
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP