Status:
TERMINATED
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study
Lead Sponsor:
UNEEG Medical A/S
Conditions:
Hypoglycemia
Eligibility:
All Genders
18-70 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01238016
Start Date
November 1 2010
End Date
August 1 2014
Last Update
August 17 2016
Active Locations (1)
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1
Esbjerg Sygehus
Esbjerg, Denmark, 6700