NCT01295788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

February 14, 2011

Last Update Submit

May 28, 2021

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Adherence to CGM (hours per week)

    Number of hours of RT-CGM use per week

    one year

Secondary Outcomes (6)

  • A1C

    one year

  • Readiness for change

    six months

  • Treatment Satisfaction and Quality of Life

    one year

  • Fear of Hypoglycemia

    one year

  • Barriers to Adherence

    one year

  • +1 more secondary outcomes

Study Arms (2)

Simultaneous RT-CGM and Pump Initiation

EXPERIMENTAL

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

Device: Simultaneous RT-CGM and Pump Initiation

Delayed RT-CGM Initiation

ACTIVE COMPARATOR

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

Interventions

Simultaneous RT-CGM and Pump InitiationDEVICE

Subjects in this group will start using RT-CGM at the same time as they initiate insulin pump therapy.

Also known as: Sensor-Augmented Pump Therapy at Pump Initiation
Simultaneous RT-CGM and Pump Initiation
Delayed Initiation of RT-CGMDEVICE

Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy.

Delayed RT-CGM Initiation

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4J9, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, N5Y 3T2, Canada

Location

Markham-Stouffville Hospital

Markham, Ontario, L3P 7P3, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (4)

  • 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.

    PMID: 33098212RESULT

  • 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.

    PMID: 33179818RESULT

  • 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.

    PMID: 25034216DERIVED

  • 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.

    PMID: 24876616DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Margaret L Lawson, MD

    Children's Hospital of Eastern Ontario

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Simultaneous or Delayed initiation of continuous glucose monitoring
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 15, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2014

Study Completion

December 1, 2017

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations

CA(5)