Back to resultsInvestigation of Hyposafe H02 Device in Patients With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyposafe hypoglycaemia notification device (H02)
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyposafe H02 Device
Arm Description
Hyposafe H02 Device will be used in the study
Outcomes
Primary Outcome Measures
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.
To collect self-measured blood glucose (SMBG) data to develop a hypoglycaemia notification algorithm.
Number SMBG measurements below 3 mmol/L glucose per participant
To collect continuous glucose monitoring (CGM) data to develop a hypoglycaemia notification algorithm.
Number of CGM values below 3 mmol/L glucose per participant
Secondary Outcome Measures
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)
To evaluate the performance of H02 in participants with type 1 diabetes.
Number of device deficiencies (from visit 3 to visit 13)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05495386
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNEEG Medical A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyposafe H02 Device
Arm Type
Experimental
Arm Description
Hyposafe H02 Device will be used in the study
Intervention Type
Device
Intervention Name(s)
Hyposafe hypoglycaemia notification device (H02)
Other Intervention Name(s)
H02
Intervention Description
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.
Primary Outcome Measure Information:
Title
To collect electrocardiogram (EEG) data to develop a hypoglycaemia notification algorithm.
Description
Recording of EEG characteristic hypoglycaemic related changes and EEG during normoglycemia measured as number of hours EEG data from each participant.
Time Frame
7-8 months
Title
To collect self-measured blood glucose (SMBG) data to develop a hypoglycaemia notification algorithm.
Description
Number SMBG measurements below 3 mmol/L glucose per participant
Time Frame
7-8 months
Title
To collect continuous glucose monitoring (CGM) data to develop a hypoglycaemia notification algorithm.
Description
Number of CGM values below 3 mmol/L glucose per participant
Time Frame
7-8 months
Secondary Outcome Measure Information:
Title
To evaluate the safety of H02 in participants with type 1 diabetes.
Description
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)
Time Frame
7-8 months
Title
To evaluate the performance of H02 in participants with type 1 diabetes.
Description
Number of device deficiencies (from visit 3 to visit 13)
Time Frame
7-8 months
Title
To evaluate the surgeon satisfaction of H02 in participants with type 1 diabetes.
Description
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
Time Frame
0 and 7-8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes
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