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

NCT ID: NCT01238016

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-08-31

Brief Summary

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

Detailed Description

Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device Performance: To evaluate the stability of the hypoglycaemia alarm device.

Conditions

Hypoglycemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

device

Device implant and EEG recording

Group Type: OTHER

experimental

Intervention Type: DEVICE

Interventions

experimental

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Chemotherapeutic drugs of any kind
• Methotrexate
• Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
• Abuse of alcohol (defined as consumption of > 250g alcohol (in Danish: 21 "genstande") per week or abuse of any other neuroactive substances
• Infection at the site of device-implantation
• Any hemorrhagic disease
• Diving (snorkel diving allowed) or parachute jumping
• Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UNEEG Medical A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Esbjerg Sygehus

Esbjerg, , Denmark

Countries

Denmark

Other Identifiers

H01A03

Identifier Type: -

Identifier Source: org_study_id