Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Hyposafe hypoglycaemia notification device (H02)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyposafe H02 Device<br>Hyposafe H02 Device will be used in the study | Device: Hyposafe hypoglycaemia notification device (H02)<br>* The H02 device consists of two parts: An implantable part which records the EEG signal and transmits the signal wirelessly to the external device. The external device receiving signals and storing data from the implant.<br>* Other names: H02;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect electrocardiogram (EEG) data to develop a hypoglycaemia notification algorithm. | Recording of EEG characteristic hypoglycaemic related changes and EEG during normoglycemia measured as number of hours EEG data from each participant. | 7-8 months | 
| To collect self-measured blood glucose (SMBG) data to develop a hypoglycaemia notification algorithm. | Number SMBG measurements below 3 mmol/L glucose per participant | 7-8 months | 
| To collect continuous glucose monitoring (CGM) data to develop a hypoglycaemia notification algorithm. | Number of CGM values below 3 mmol/L glucose per participant | 7-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of H02 in participants with type 1 diabetes. | Number of adverse events 29 weeks after implantation (from visit 3 to visit 14) Number of adverse device effects (ADEs) 29 weeks after implantation (from visit 3 to visit 14) | 7-8 months | 
| To evaluate the performance of H02 in participants with type 1 diabetes. | Number of device deficiencies (from visit 3 to visit 13) | 7-8 months | 
| To evaluate the surgeon satisfaction of H02 in participants with type 1 diabetes. | Surgeon satisfaction will be evaluated by questionnaires after the implantation at visit 3 and after explantation at visit 13 of the implantable part of Hyposafe H02 Device | 0 and 7-8 months |