Clincosm LogoSign in Get a demo

Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes

Sponsor
UNEEG Medical A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05495386
Collaborator
(none)
25
Enrollment
1
Arm
18
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hyposafe hypoglycaemia notification device (H02)
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Investigation of Hypoglycaemia-induced EEG Changes in Participants With Type 1 Diabetes by Use of the Hyposafe H02 Device
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hyposafe H02 Device

Hyposafe H02 Device will be used in the study

Device: Hyposafe hypoglycaemia notification device (H02)
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.
Other Names:
  • H02

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    3. 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

    Secondary Outcome Measures

    1. 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)

    2. 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)

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • UNEEG Medical A/S

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UNEEG Medical A/S
    ClinicalTrials.gov Identifier:
    NCT05495386
    Other Study ID Numbers:
    • U010
    First Posted:
    Aug 10, 2022
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Aug 10, 2022