An exploratory study evaluating the measurement of non-glycaemic parameters as markers of impending or present hypoglycaemia in people with Type 1 Diabetes.

This study aims to obtain overnight exploratory data regarding the relationship of non-glycaemic parameters (such as wrist and finger tremor and temperature to hypoglycaemia) in Type 1 Diabetes participants. This study intends to evaluate the accuracy of a non-invasive device designed to detect these early signs of hypoglycaemia. The Investigational Device (ID) consists of a wrist band connected by a flexible wire to a ring. Participants will wear the ID overnight placed on the wrist and middle finger of the non-dominant hand prior to retiring to bed. The ID will be removed after the participant wakes in the morning. Parameters including wrist and finger tremor and temperature will be monitored continuously by the ID during wear. Following baseline assessment, participants will be provided with education regarding the ID. Participants will be instructed to undertake reference capillary blood glucose measurements (a minimum of 4 times a day over the 2 week study period) and to wear Continuous Glucose Monitoring (CGM) sensors for the two-week study duration. During the study, the participants will also be instructed to keep a diary documenting activity, diet, capillary glucose reading, insulin, and hypogylcaemic episodes. Participants will attend the Clinical Trials Centre (CTC) on Day 8 to have the CGM sensor changed. On Day 15, participants will attend the CTC for collection of the study devices and diary.