Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes

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