Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study

NCT01238016 | Terminated

• 1 other identifier: H01A03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The trial aims at measuring the safety and performance of the Hyposafe device.

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Device performance

  End of observation

Study Arms (1)

device

OTHER

Device implant and EEG recording

Device: experimental

Interventions

experimental DEVICE

device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy control subjects or and
• Male and female patient with type 1 diabetes for at least one year
• Age 18-70 years
• Impaired awareness of hypoglycaemia as defined by
• A score of ≥4 on the Gold-scale or
• Two or more occasions of severe hypoglycaemia (need of help from third person) within the past 12 month
• Multiple injection insulin therapy or continuous insulin injection therapy
• For female participants: Not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period

You may not qualify if:

• Severe cardiac disease
• History of myocardial infarction
• Cardiac arrhythmia
• Previous stroke or cerebral haemorrhage and any other structural cerebral disease
• Active cancer or cancer diagnosis within the past five years
• Uremia defined as s-creatinine above 3 times upper reference value
• Liver disease defined as s-ALAT above 3 times upper reference interval
• Inability to understand the informed consent
• Epilepsy
• Use of antiepileptic drugs for any purposes
• Clinical important hearing impairment
• Use of active implantable medical device including
• Pacemaker and ICD-unit
• Cochlear implant
• Use of following drugs

Sponsors & Collaborators

• UNEEG Medical A/S: lead

Study Sites (1)

Esbjerg Sygehus

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 10, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

DK (1)