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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Simultaneous RT-CGM and Pump Initiation
Delayed Initiation of RT-CGM
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McMaster Children's Hospital
  • Children's Hospital of Western Ontario
  • Markham-Stouffville Hospital
  • Children's Hospital of Eastern Ontario
  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simultaneous RT-CGM and Pump Initiation

Delayed RT-CGM Initiation

Arm Description

The experimental group will initiate RT-CGM at the same time as they begin insulin pump therapy.

The control group will use standard pump therapy until the 6 month study visit at which time RT-CGM will be initiated.

Outcomes

Primary Outcome Measures

Adherence to CGM (hours per week)
Number of hours of RT-CGM use per week

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2011
Last Updated
May 28, 2021
Sponsor
Children's Hospital of Eastern Ontario
Collaborators
Juvenile Diabetes Research Foundation, Canadian Clinical Trial Network
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1. Study Identification

Unique Protocol Identification Number
NCT01295788
Brief Title
Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (The CGM TIME Trial)
Official Title
Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 2011 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario
Collaborators
Juvenile Diabetes Research Foundation, Canadian Clinical Trial Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Simultaneous or Delayed initiation of continuous glucose monitoring
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simultaneous RT-CGM and Pump Initiation
Arm Type
Experimental
Arm Description
The experimental group will initiate RT-CGM at the same time as they begin insulin pump therapy.
Arm Title
Delayed RT-CGM Initiation
Arm Type
Active Comparator
Arm Description
The control group will use standard pump therapy until the 6 month study visit at which time RT-CGM will be initiated.
Intervention Type
Device
Intervention Name(s)
Simultaneous RT-CGM and Pump Initiation
Other Intervention Name(s)
Sensor-Augmented Pump Therapy at Pump Initiation
Intervention Description
Subjects in this group will start using RT-CGM at the same time as they initiate insulin pump therapy.
Intervention Type
Device
Intervention Name(s)
Delayed Initiation of RT-CGM
Intervention Description
Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy.
Primary Outcome Measure Information:
Title
Adherence to CGM (hours per week)
Description
Number of hours of RT-CGM use per week
Time Frame
one year
Secondary Outcome Measure Information:
Title
A1C
Description
Hemoglobin A1C
Time Frame
one year
Title
Readiness for change
Description
SOCRATES - Diabetes Version
Time Frame
six months
Title
Treatment Satisfaction and Quality of Life
Description
Insulin Delivery Systems Rating Questionnaire (IDSRQ)
Time Frame
one year
Title
Fear of Hypoglycemia
Description
Hypoglycemia Fear Scale (HFS-98)
Time Frame
one year
Title
Barriers to Adherence
Description
Modified Barriers to Adherence Questionnaire (MBAQ)
Time Frame
one year
Title
Perception of Barriers/Facilitators to RT-CGM Use
Description
CGM Satisfaction Scale (CGM-SAT)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret L Lawson, MD
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Study Director
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4J9
Country
Canada
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N5Y 3T2
Country
Canada
Facility Name
Markham-Stouffville Hospital
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 7P3
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33098212
Citation
Lawson ML, Verbeeten KC, Courtney JM, Bradley BJ, McAssey K, Clarson C, Kirsch S, Curtis JR, Mahmud FH, Richardson C, Cooper T, Chan J, Tang K. Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial. Pediatr Diabetes. 2021 Mar;22(2):279-287. doi: 10.1111/pedi.13144. Epub 2020 Nov 4.
Results Reference
result
PubMed Identifier
33179818
Citation
Verbeeten KC, Perez Trejo ME, Tang K, Chan J, Courtney JM, Bradley BJ, McAssey K, Clarson C, Kirsch S, Curtis JR, Mahmud FH, Richardson C, Cooper T, Lawson ML; CGM TIME Trial Study Group and the JDRF Canadian Clinical Trials Group. Fear of hypoglycemia in children with type 1 diabetes and their parents: Effect of pump therapy and continuous glucose monitoring with option of low glucose suspend in the CGM TIME trial. Pediatr Diabetes. 2021 Mar;22(2):288-293. doi: 10.1111/pedi.13150. Epub 2020 Nov 27.
Results Reference
result
PubMed Identifier
25034216
Citation
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.
Results Reference
derived
PubMed Identifier
24876616
Citation
Olivier P, Lawson ML, Huot C, Richardson C, Nakhla M, Romain J. Lessons learned from a pilot RCT of simultaneous versus delayed initiation of continuous glucose monitoring in children and adolescents with type 1 diabetes starting insulin pump therapy. J Diabetes Sci Technol. 2014 May;8(3):523-8. doi: 10.1177/1932296814524855. Epub 2014 Feb 27.
Results Reference
derived

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

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