Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes
NCT ID: NCT05495386
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-09-01
2024-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Hyposafe H02 Device
Hyposafe H02 Device will be used in the study
Hyposafe hypoglycaemia notification device (H02)
The H02 device consists of two parts:
1. An implantable part which records the EEG signal and transmits the signal wirelessly to the external device.
2. The external device receiving signals and storing data from the implant.
Interventions
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Hyposafe hypoglycaemia notification device (H02)
The H02 device consists of two parts:
1. An implantable part which records the EEG signal and transmits the signal wirelessly to the external device.
2. The external device receiving signals and storing data from the implant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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UNEEG Medical A/S
INDUSTRY
Responsible Party
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Other Identifiers
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U010
Identifier Type: -
Identifier Source: org_study_id