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

May 28, 2021 updated by: Margaret Lawson, Children's Hospital of Eastern Ontario

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
        • McMaster Children's Hospital
      • London, Ontario, Canada, N5Y 3T2
        • Children's Hospital of Western Ontario
      • Markham, Ontario, Canada, L3P 7P3
        • Markham-Stouffville Hospital
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Eastern Ontario

Collaborators

Juvenile Diabetes Research Foundation
Canadian Clinical Trial Network

Investigators

  • Study Director: Margaret L Lawson, MD, Children's Hospital of Eastern Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2011

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (ESTIMATE)

February 15, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEO 09/05E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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