Clinical trial NCT05495386: Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes
Official title: Investigation of Hypoglycaemia-induced EEG Changes in Participants With Type 1 Diabetes by Use of the Hyposafe H02 Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: UNEEG Medical A/S
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To collect electrocardiogram (EEG) data to develop a hypoglycaemia notification algorithm.
timeFrame: 7-8 months
measure: To collect self-measured blood glucose (SMBG) data to develop a hypoglycaemia notification algorithm.
timeFrame: 7-8 months
measure: To collect continuous glucose monitoring (CGM) data to develop a hypoglycaemia notification algorithm.
timeFrame: 7-8 months
Secondary outcomes:
measure: To evaluate the safety of H02 in participants with type 1 diabetes.
timeFrame: 7-8 months
measure: To evaluate the performance of H02 in participants with type 1 diabetes.
timeFrame: 7-8 months
measure: To evaluate the surgeon satisfaction of H02 in participants with type 1 diabetes.
timeFrame: 0 and 7-8 months
Other outcomes:
Locations:
Study officials:
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