Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Device: Hyposafe hypoglycaemia notification device (H02)
- Registration Number
- NCT05495386
- Lead Sponsor
- UNEEG Medical A/S
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hyposafe H02 Device Hyposafe hypoglycaemia notification device (H02) Hyposafe H02 Device will be used in the study
- Primary Outcome Measures
Name Time Method To collect continuous glucose monitoring (CGM) data to develop a hypoglycaemia notification algorithm. 7-8 months Number of CGM values below 3 mmol/L glucose per participant
To collect electrocardiogram (EEG) data to develop a hypoglycaemia notification algorithm. 7-8 months Recording of EEG characteristic hypoglycaemic related changes and EEG during normoglycemia measured as number of hours EEG data from each participant.
To collect self-measured blood glucose (SMBG) data to develop a hypoglycaemia notification algorithm. 7-8 months Number SMBG measurements below 3 mmol/L glucose per participant
- Secondary Outcome Measures
Name Time Method To evaluate the surgeon satisfaction of H02 in participants with type 1 diabetes. 0 and 7-8 months 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
To evaluate the safety of H02 in participants with type 1 diabetes. 7-8 months * 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)To evaluate the performance of H02 in participants with type 1 diabetes. 7-8 months Number of device deficiencies (from visit 3 to visit 13)