Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05495386
• Other study ID #: U010
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2023
• Source: UNEEG Medical A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UNEEG Medical A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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