Update on the General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) trial: statistical analysis plan for a multi-centre randomised controlled trial
Sharmala Thuraisingam, Patty Chondros, Max Catchpool, Kim Dalziel, Jo-Anne Manski-Nankervis, Jane Speight, Elizabeth Holmes-Truscott, Ralph Audehm, Jason Chiang, Irene Blackberry, David O'Neal, Kamlesh Khunti, James Best, John Furler
TRIALS | BMC | Published : 2019
BACKGROUND: General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) is a multicentre, individually randomised controlled trial aiming to compare the use of intermittent retrospective continuous glucose monitoring (r-CGM) to usual care in patients with type 2 diabetes attending general practice. The study protocol was published in the British Medical Journal Open and described the principal features of the statistical methods that will be used to analyse the trial data. This paper provides greater detail on the statistical analysis plan, including background and justification for the statistical methods chosen, in accordance with SPIRIT g..View full abstract
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Awarded by National Health and Medical Research Council
Funding for this study has been provided by the National Health and Medical Research Council Project Grant (ID APP1104241). Additional funding has been provided by Sanofi Australia. Libre Pro reader devices, sensors, and software will be provided by Abbott Diabetes Care as in-kind support. Study sponsor and funders have had no role in the development of this analysis plan.