All subject data will be recorded on printed case report form (CRF) by the authorized investigator (i.e. research physician) and/or personnel that is instructed in performing these administrative tasks and study procedures. In the latter case, data will always be reviewed by the investigator. All subject related data will be stored for 15 years. Subject data, both anonymous (e.g. CRFs) or not (e.g. source documents), will always be stored securely, in a locked cabinet in the Diabetes Center VUMC or on password secured computers.