Clinical trial NCT01295788: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Canadian Clinical Trial Network
First posted: 2011-02-15
Enrollment: 144
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Simultaneous or Delayed initiation of continuous glucose monitoring
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adherence to CGM (hours per week)
timeFrame: one year
Secondary outcomes:
measure: A1C
timeFrame: one year
measure: Readiness for change
timeFrame: six months
measure: Treatment Satisfaction and Quality of Life
timeFrame: one year
measure: Fear of Hypoglycemia
timeFrame: one year
measure: Barriers to Adherence
timeFrame: one year
measure: Perception of Barriers/Facilitators to RT-CGM Use
timeFrame: one year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital of Western Ontario
state: Ontario
city: Markham
country: Canada
facility: Markham-Stouffville Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Margaret L Lawson, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.