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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.

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 GroupJDRF Canadian Clinical Trial Network CCTN11 - BMC Pediatr (2014)

Bottom Line: We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation.Baseline characteristics were similar between the treatment groups.Analysis of 12 month primary outcomes will begin in September 2014.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Endocrinology and Metabolism, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada. lawson@cheo.on.ca.

ABSTRACT

Background: Continuous glucose monitoring (CGM) has been shown to improve glucose control in adults with type 1 diabetes. Effectiveness of CGM is directly linked with CGM adherence, which can be challenging to maintain in children and adolescents. We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation.

Methods/design: The CGM TIME Trial is a multicenter randomized controlled trial. Eligible children and adolescents (5-18 years) with established type 1 diabetes were randomized to simultaneous initiation of pump (Medtronic Veo©) and CGM (Enlite©) or to standard pump therapy with delayed CGM introduction. Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation. Secondary outcomes include glycemic variability, stage of readiness, and other patient-reported outcomes with follow-up to 24 months. 144 (95%) of the 152 eligible patients were enrolled and randomized. Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference in CGM adherence and 86% power to detect a between group difference in hemoglobin A1C. Baseline characteristics were similar between the treatment groups. Analysis of 12 month primary outcomes will begin in September 2014.

Discussion: The CGM TIME Trial is the first study to examine the relationship between timing of CGM initiation, readiness for behaviour change, and subsequent CGM adherence in pump naïve children and adolescents. Its findings will advance our understanding of when and how to initiate CGM in children and adolescents with type 1 diabetes.

Trial registration: ClinicalTrial.gov NCT01295788. Registered 14 February 2011.

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Related in: MedlinePlus

CONSORT flow diagram.
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Figure 2: CONSORT flow diagram.

Mentions: Recruitment began at the lead site (CHEO) on June 30, 2011 with all 5 sites operational by October 15, 2011. The minimum sample size of 128 was reached on March 19, 2013. Recruitment closed on May 31, 2013 with 144 randomized subjects (Figure 2 – Consort Flow Diagram). Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference at six and twelve months for CGM adherence and 86% power to detect a between group difference in A1C.


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.

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 GroupJDRF Canadian Clinical Trial Network CCTN11 - BMC Pediatr (2014)

CONSORT flow diagram.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4109785&req=5

Figure 2: CONSORT flow diagram.
Mentions: Recruitment began at the lead site (CHEO) on June 30, 2011 with all 5 sites operational by October 15, 2011. The minimum sample size of 128 was reached on March 19, 2013. Recruitment closed on May 31, 2013 with 144 randomized subjects (Figure 2 – Consort Flow Diagram). Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference at six and twelve months for CGM adherence and 86% power to detect a between group difference in A1C.

Bottom Line: We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation.Baseline characteristics were similar between the treatment groups.Analysis of 12 month primary outcomes will begin in September 2014.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Endocrinology and Metabolism, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada. lawson@cheo.on.ca.

ABSTRACT

Background: Continuous glucose monitoring (CGM) has been shown to improve glucose control in adults with type 1 diabetes. Effectiveness of CGM is directly linked with CGM adherence, which can be challenging to maintain in children and adolescents. We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation.

Methods/design: The CGM TIME Trial is a multicenter randomized controlled trial. Eligible children and adolescents (5-18 years) with established type 1 diabetes were randomized to simultaneous initiation of pump (Medtronic Veo©) and CGM (Enlite©) or to standard pump therapy with delayed CGM introduction. Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation. Secondary outcomes include glycemic variability, stage of readiness, and other patient-reported outcomes with follow-up to 24 months. 144 (95%) of the 152 eligible patients were enrolled and randomized. Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference in CGM adherence and 86% power to detect a between group difference in hemoglobin A1C. Baseline characteristics were similar between the treatment groups. Analysis of 12 month primary outcomes will begin in September 2014.

Discussion: The CGM TIME Trial is the first study to examine the relationship between timing of CGM initiation, readiness for behaviour change, and subsequent CGM adherence in pump naïve children and adolescents. Its findings will advance our understanding of when and how to initiate CGM in children and adolescents with type 1 diabetes.

Trial registration: ClinicalTrial.gov NCT01295788. Registered 14 February 2011.

Show MeSH
Related in: MedlinePlus