An evaluation of the performance and user acceptance of a mobile real-time continuous glucose monitoring system in people with type 1 and type 2 diabetes treated with multiple daily injections of insulin.

This study aims to evaluate the performance and user acceptance of the mobile real-time continuous glucose monitoring (RT-CGM) system in people with type 1 and type 2 diabetes treated with multiple daily injections of insulin. The mobile RT-CGM system consists of an electrochemical redundant glucose sensor and transmitter linked to a mobile device displaying real-time glucose information. The glucose sensor is inserted subcutaneously in the abdominal region and measures glucose in the interstitial fluid via a glucose oxidase reaction. Twenty people (10 with type 1 diabetes, and 10 with type 2 diabetes > 10 years duration) will be recruited for this 12 week randomised crossover study, comprising two sequential 6 weeks study stages (Intervention and Usual Care). The Intervention stage involves using the mobile RT-CGM system. During the Usual Care stage participants undergo their usual diabetes management (including multiple daily injections of insulin and finger prick glucose monitoring) and they will have masked CGM with a glucose sensor linked to a recorder during the final 10 days of the stage. Participants will attend the clinical trial centre (CTC) for study visits at study beginning, 6 weeks, 12 weeks and either on day 32 or 74 depending on randomisation (total 4 visits). There will also be telephone visits to ascertain protocol compliance. Clinical examinations, frequent sampling tests for venous glucose measurement, HbA1c and 1,5-anhydroglucitol levels will be performed at CTC visits. A user evaluation questionnaire will be completed by participants after the 6 week Intervention stage. Sensors will be inserted and removed at the CTC by the research team, and participants will be educated regarding changing sensors at home. Participants will also be instructed to take finger-prick blood glucose measurements via the study meter at least 4 times per day and to record activities, meals and symptomatic hypoglycaemic episodes in a diary.