Non-invasive, and needle-free, continuous glucose monitor for children and young people living with diabetes
Type 1 diabetes
Preliminary Wearability study: up to 5 young people aged 5-<18 years living with diabetes attending the Bristol Royal Hospital for Children Diabetes Service will be asked to wear the 'Glucopatch' device for 4 to 5 hours in the Children's Hospital Research ward to check suitable sites for wearing device, ease of attachment and use, check that data downloads to Transdermal Diagnostics app on dedicated mobile phone which will be stored in a server cloud accessible to TD and research team. Finally this study will generate further information on patient preferences for use. Main Study: 30 young people aged 5-<18 years living with diabetes will be recruited from the ~550 patients attending the Bristol Royal Hospital for Children Diabetes Service. Once assent/consent has been received, the patient and family will attend a baseline meeting with the research nurse to: (1) Explain the device usage including application, requirements for downloading data to a mobile app (provided by Transdermal), when to take finger pricks and how to record accurate date and time of measures as well as actual value. Two finger pricks will be requested pre-meals (Breakfast and tea-time) and two about 2 hours after these meals. This meeting will take about an hour. (2) The family will then take the devices home and apply a new device each evening before bedtime. The family will be asked to take finger pricks each day (x4) and record times and dates for accurate comparison with new device downloaded data. (3) After 10 days or at a convenient time for the family, they will return the finger prick diary, an adverse event diary (this will be explained to participants and families: skin irritation, device falling off prematurely etc.) and any remaining devices. The family will take part in a short interview with the research associate to establish preliminary perceptions of the device and problems encountered with device usage: the researcher and participants can use the adverse event diary as a p
Child or Young Person living with type 1 diabetes on CGMS and any form of insulin therapy.
Children in diabetes service with any other form of diabetes (Type 2, CFRD, MODY) or not on CGMS for management of diabetes.