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 Pediatrics

Nicholas Barrowman⁶  Gopalan Rajamannar⁴  Cynthia J Downie⁴  Tammy Cooper³  Jennilea Courtney⁶  Christine Richardson³  Jacqueline R Curtis¹  Farid H Mahmud¹  Susan E Kirsch⁵  Cheril Clarson²  Karen McAssey⁷  Brenda Bradley⁶  Margaret L Lawson⁶ 

[1] Hospital for Sick Children, Toronto, ON, Canada;Children’s Hospital, London Health Sciences Centre, London, ON, Canada;Children’s Hospital of Eastern Ontario, Ottawa, ON, Canada;Robarts Clinical Trials Inc, London, ON, Canada;Markham-Stouffville Hospital, Markham, ON, Canada;CHEO Research Institute, Ottawa, ON, Canada;McMaster Children’s Hospital, Hamilton, ON, Canada

关键词: Treatment satisfaction;    Quality of life;    Adolescents;    Children;    Glycosylated hemoglobin;    Pediatrics;    Adherence;    Type 1 diabetes;    Continuous subcutaneous insulin infusion;    Continuous glucose monitoring;   

Others  :  1138539
DOI  :  10.1186/1471-2431-14-183

 received in 2014-06-02, accepted in 2014-07-04,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Lawson et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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