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Prevention of Severe Hypoglycaemia With Hypo-Safe Hypoglycaemia Alarm Device

NCT01178476 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-03-10

No results posted yet for this study

Summary

Hypoglycaemia is the most common acute complication in insulin-treated diabetes. The fear of hypoglycaemia discourages diabetic subjects from the attempt to maintain tight glycemic control, which in turn leads to increased diabetes related morbidity and mortality.

Neuroglycopenic hypoglycaemia in insulin-treated diabetic patients is associated with characteristic changes in EEG with a decrease in alpha activity and an increase in delta and theta activity. We have recently demonstrated that hypoglycaemia-associated EEG-changes can be recorded from subcutaneously placed electrodes using an automated mathematical algorithm based on non-linear spectral analysis. Experimental findings hold promises that an alarm, given at the time of EEG-changes, can help the patients to avoid severe hypoglycaemia by ingestion of carbohydrate.

This is the first larger scale trial testing the clinical applicability of a hypoglycaemia-alarm based on real-time analysis of EEG-signals.

Conditions

Interventions

DEVICE

Hyposafe Hypoglycaemia alarm device

An EEG based hypoglycemia alarm is tested against standard glucose measurement on the risk of severe hypoglycemia

Sponsors & Collaborators

  • UNEEG Medical A/S

    lead INDUSTRY

Principal Investigators

  • Birger Thorsteinsson, MD. · Medical Department, Hillerød Sygehus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-01-31
Completion
2011-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT01178476 on ClinicalTrials.gov