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

• ClinicalTrials.gov Identifier: NCT01295788
• Recruitment Status: Unknown
• First Posted: February 15, 2011
• Last Update Posted: July 13, 2017
• Sponsor: Children's Hospital of Eastern Ontario
• Collaborators: JDRF Canadian Clinical Trial Network; Juvenile Diabetes Research Foundation
• Information provided by (Responsible Party): Margaret Lawson, Children's Hospital of Eastern Ontario

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.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes	Device: Simultaneous RT-CGM and Pump Initiation; Device: Delayed Initiation of RT-CGM	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Simultaneous or Delayed initiation of continuous glucose monitoring
• Masking: None (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
• Actual Study Start Date: June 2011
• Actual Primary Completion Date: June 2014
• Estimated Study Completion Date: December 2017

Arms and Interventions

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 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.

Outcome Measures

Primary Outcome Measures :

1. Adherence to CGM (hours per week) [ Time Frame: one year ]
   Number of hours of RT-CGM use per week

Secondary Outcome Measures :

1. A1C [ Time Frame: one year ]
   Hemoglobin A1C
2. Readiness for change [ Time Frame: six months ]
   SOCRATES - Diabetes Version
3. Treatment Satisfaction and Quality of Life [ Time Frame: one year ]
   Insulin Delivery Systems Rating Questionnaire (IDSRQ)
4. Fear of Hypoglycemia [ Time Frame: one year ]
   Hypoglycemia Fear Scale (HFS-98)
5. Barriers to Adherence [ Time Frame: one year ]
   Modified Barriers to Adherence Questionnaire (MBAQ)
6. Perception of Barriers/Facilitators to RT-CGM Use [ Time Frame: one year ]
   CGM Satisfaction Scale (CGM-SAT)

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

Locations

Canada, Ontario

McMaster Children's Hospital

Hamilton, Ontario, Canada, L8S 4J9

Children's Hospital of Western Ontario

London, Ontario, Canada, N5Y 3T2

Markham-Stouffville Hospital

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

Sponsors and Collaborators

Children's Hospital of Eastern Ontario

JDRF Canadian Clinical Trial Network

Juvenile Diabetes Research Foundation

Investigators

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

More Information

Additional Information:

JDRF Canadian Clinical Trial Network 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Margaret Lawson, Professor of Pediatrics, Children's Hospital of Eastern Ontario
• ClinicalTrials.gov Identifier: NCT01295788
• Other Study ID Numbers: CHEO 09/05E
• First Posted: February 15, 2011
• Last Update Posted: July 13, 2017
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Insulin, Globin Zinc; Hypoglycemic Agents; Physiological Effects of Drugs