An evaluation of user acceptance and performance of a mobile real-time continuous glucose monitoring system.

This study aims to evaluate the user acceptance of a real time continuous glucose monitoring (RT-CGM) system in people with T1D. This study also intends to evaluate the performance of the system and the the impact it has on glycaemia. The RT-CGM system consists of a glucose sensor and transmitter (measuring interstitial fluid glucose level), and a linked study iPod displaying glucose information. This study involves a single group of 10 participants with T1D using the RT-CGM system. Following baseline clinical assessment, the researcher will provide participants with education about the study devices taking approximately 1 hour. Initial venous blood sampling for HbA1c and 1,5 anhydroglucitol (1,5 AG) will be taken. One hour following sensor insertion, participants will undergo a frequent sampling test (FST) with collection of venous blood to measure plasma glucose at 20 minute intervals for a duration of 3 hours. For the 2 week study period participants will be instructed to undertake reference capillary blood glucose measurements (a minimum of 4 times a day) and to wear the RT-CGM system continuously. For the study duration, participants will also be instructed to keep a diary documenting activity, diet, capillary blood glucose reading, insulin, and symptomatic hypoglycaemia episodes. Participants will attend a study visit on Day 8 to have their RT-CGM sensor changed, iPod data downloaded and their glucose data reviewed. On Day 15, participants will attend their final study visit for collection of the study devices and diary. An intravenous cannula will be inserted in the cubital fossa and venous blood for HbA1c and 1,5 AG will be taken. Participants will then be provided a meal and have venous blood collected at 20 minute intervals over the following 3 hours for plasma glucose measurements. A user evaluation questionnaire will also be completed.