Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes

Investigation of Hypoglycaemia-induced EEG Changes in Participants With Type 1 Diabetes by Use of the Hyposafe H02 Device

This clinical study is designed to collect data for further development of a hypoglycaemia notification algorithm. In addition, information regarding safety will be collected and analysed.

H02 is an implantable continuous EEG recorder that consists of an implant and an external device. The H02 system is based on a subcutaneous EEG measurement and acquisition of the EEG signal from the implant.

Participant will have the implantable part of H02 implanted under local anaesthesia. After a healing period, the participants will start using the external part of H02. They will wear the external part of H02 as much as possible both during daytime and night-time. The participant will use their own continuous glucose monitoring (CGM) during the study as normal practice. The participants will be exposed to insulin-induced hypoglycaemia once during the study.

Inclusion Criteria:

• Informed consent
• Type 1 diabetes diagnosed at least five years prior to inclusion in the study
• Age 18-70 years
• Impaired awareness, i.e., defined as unaware by the Pedersen-Bjergaard scale and history of at least one severe hypoglycaemia within the preceding year
• Use of continuous glucose monitoring at study start

Exclusion Criteria:

• High risk of surgical complications
• Involved in therapies with medical devices that deliver electrical energy into the area around the implant
• Infection at the site of device implantation
• Contraindications to the local anaesthetic used during implantation and explantation
• Have cochlear implant(s)
• Subject is scheduled to undergo MRI scan, ultrasound, radiation, or electrical current induced close to the implant, within 6 months after enrolment
• Severe cardiac disease
• History of stroke/ cerebral haemorrhage and any other structural cerebral disease
• Active cancer or cancer diagnosis within the past 5 years