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

NCT02402153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-09-26

Study results available
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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.

Conditions

  • Healthy

Interventions

DEVICE

Hyposafe device

Subcutaneous EEG recorder for EEG measurements

Sponsors & Collaborators

  • UNEEG Medical A/S

    lead INDUSTRY

Principal Investigators

  • Birger Thorsteinsson, MD, DMSc · Nordsjaellands Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-01-31
Completion
2017-03-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02402153 on ClinicalTrials.gov