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Type 1 DiabetesNCT01295788

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

A study testing Simultaneous RT-CGM and Pump Initiation and Delayed Initiation of RT-CGM in people with Type 1 Diabetes, run by Children's Hospital of Eastern Ontario at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Simultaneous RT-CGM and Pump Initiation and Delayed Initiation of RT-CGM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
5 sitesCanada
Study dates
May 2011to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • McMaster Children's Hospital

    Hamilton, Ontario, L8S 4J9

  • Children's Hospital of Western Ontario

    London, Ontario, N5Y 3T2

  • Markham-Stouffville Hospital

    Markham, Ontario, L3P 7P3

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
Simultaneous RT-CGM and Pump Initiation, Delayed Initiation of RT-CGM
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simultaneous RT-CGM and Pump InitiationDevice

    Also called Sensor-Augmented Pump Therapy at Pump Initiation

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

  • Delayed Initiation of RT-CGMDevice

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

Study groups in NCT01295788
Study groupRoleWhat they receive
Simultaneous RT-CGM and Pump InitiationExperimentalThe experimental group will initiate RT-CGM at the same time as they begin insulin pump therapy.
Receives: Device: Simultaneous RT-CGM and Pump Initiation
Delayed RT-CGM InitiationActive comparatorThe control group will use standard pump therapy until the 6 month study visit at which time RT-CGM will be initiated.
Receives: Device: Delayed Initiation of RT-CGM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to CGM (hours per week)

    Number of hours of RT-CGM use per week

    Measured: one year

Secondary outcomes (6)

  1. A1C

    Hemoglobin A1C

    Measured: one year

  2. Readiness for change

    SOCRATES - Diabetes Version

    Measured: six months

  3. Treatment Satisfaction and Quality of Life

    Insulin Delivery Systems Rating Questionnaire (IDSRQ)

    Measured: one year

  4. Fear of Hypoglycemia

    Hypoglycemia Fear Scale (HFS-98)

    Measured: one year

  5. Barriers to Adherence

    Modified Barriers to Adherence Questionnaire (MBAQ)

    Measured: one year

  6. Perception of Barriers/Facilitators to RT-CGM Use

    CGM Satisfaction Scale (CGM-SAT)

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJun 2014
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Simultaneous or Delayed initiation of continuous glucose monitoring
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01295788
Sponsor's protocol ID
CHEO 09/05E
Status last verified
May 2021
First submitted
14 Feb 2011
Last updated
2 Jun 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33098212

  • 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.

    PubMed 33179818

  • 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.

    PubMed 25034216

  • 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.

    PubMed 24876616

Questions about this trial

What is this clinical trial studying?

A study testing Simultaneous RT-CGM and Pump Initiation and Delayed Initiation of RT-CGM in people with Type 1 Diabetes, run by Children's Hospital of Eastern Ontario at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to CGM (hours per week) (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01295788, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.

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