Hyposafe hypoglycaemia notification device (H02) : version U010
Research type
Research Study
Full title
Investigation of hypoglycaemia-induced EEG changes in participants with type 1 diabetes by use of the hyposafe H02 device.
IRAS ID
312431
Contact name
Nick Oliver
Contact email
Sponsor organisation
UNEEG medical A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
This feasibility study is aiming to investigate whether a medical device called the Hyposafe hypoglycaemia notification device (H02) can collect data to accurately detect changes in brain activity (when blood sugar level significantly drops too low) in adults with type-1 diabetes. Not all individuals with type-1 diabetes are aware that they are experiencing hypoglycaemic event which can be dangerous and life-threatening if not treated promptly. The device is designed to detect signals that the brain sends when the blood sugar levels are too low which then notifies the individual to take action (as advised by their doctor) to avoid the event happening. The study aims to collect data for development of the algorithm for this hypoglycaemia notification; plus data will be collected and analysed to assess device safety. In this small feasibility study, up to 25 adults (with 20 full completers) from one site with type 1 diabetes will participate for a duration of 7-8 months.
REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0110
Date of REC Opinion
28 Aug 2022
REC opinion
Favourable Opinion