Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Hyposafe hypoglycaemia notification device (H02)

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UNEEG Medical A/S

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: U010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No