NCT02402153

Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: UNEEG Medical A/S · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objective of this pilot trial is to demonstrate the safety and the performance of the Hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes patients.

Detailed description

1. Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device. 2. Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device. 3. Usability: To obtain information about the subjects use and acceptance of the Hyposafe Hypoglycaemia alarm device.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Hyposafe device	Subcutaneous EEG recorder for EEG measurements

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2015-03-30
• Last updated: 2018-09-26
• Results posted: 2018-09-26

Locations

1 site across 1 country: Denmark