Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UNEEG Medical A/S
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.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
