The Leicester Diabetes Centre in conjunction with the Leicester Clinical Trials Unit will be responsible for all elements of study management on an ongoing basis. For example, the CRFs will be checked for completeness at the end of a measurement session and any data queries will be raised with the research nurse who recorded the data in the first instance. Repeated errors will be referred to the Senior Research Team Manager who will instigate training. The study monitor will remain external to the study team thereby ensuring independence during the sponsor monitoring process. All in-house monitoring and audit will be performed by staff who are ICH/GCP trained and are competent in monitoring to GCP standards. A documented monitoring log and audit trail will be maintained throughout the lifetime of the study.