Abstract
BackgroundContinuous 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/DesignThe 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.DiscussionThe 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 registrationClinicalTrial.gov NCT01295788. Registered 14 February 2011.
Highlights
Continuous glucose monitoring (CGM) has been shown to improve glucose control in adults with type 1 diabetes
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
This paper describes the research design and methods of the CGM TIME Trial, recruitment, and baseline characteristics of the 144 subjects enrolled in the trial
Summary
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 children and adolescents. Abbreviations A1C: Hemoglobin A1C; BG: Blood glucose; CGM: Continuous glucose monitoring; CGM-SAT: CGM Satisfaction Scale; CHEO: Children’s Hospital of Eastern Ontario; IDSRQ: Insulin Delivery Systems Rating Questionnaire; HFS-98: Hypoglycemia Fear Scale; JDRF CCTN: JDRF Canadian Clinical Trial Network; MBAQ: Modified Barriers to Adherence Questionnaire; MDI: Multiple daily injections; SCI-R: Self-Care Inventory – Revised; SMBG: Self-monitoring of blood glucose; SOCRATES: Stages of Change Readiness and Treatment Eagerness Scale; T1D: Type 1 diabetes. Competing interests This is an investigator-initiated trial.
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