STUDY GOVERNANCE Trial Steering Committee (TSC):- TSC will comprise an independent chair, at least one other independent clinician with expertise in the management of diabetes, the chief investigator, key co-investigators, and representation from the Leicester Clinical Trials Unit. The study statisticians may attend as needed. This committee will be responsible for the overall management and oversight of the study and will meet once prior to start up and then every 6 months, normally within 2 months of the Data Safety Monitoring Committee (DSMC) (although additional meetings may be called by the Chief Investigator or TSC or DSMC chair) to review and approve protocol amendments and any sub-study proposals, review recruitment rates, protocol adherence, retention, compliance, safety issues, planned analyses and reports and act on recommendations of the DSMC. A copy of meeting minutes will be sent to the Sponsor.