Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes

Status Withdrawn

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05495386
Study type	Interventional
Source	UNEEG Medical A/S
Contact
Status	Withdrawn
Phase	N/A
Start date	September 1, 2022
Completion date	March 1, 2024

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