NCT05495386

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UNEEG Medical A/S · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-01-01
• Completion: 2024-03-01
• First posted: 2022-08-10
• Last updated: 2023-12-22