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

Study Overview
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Brief Summary
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The trial aims at measuring the safety and performance of the Hyposafe device.

Detailed Description
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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.

Official Title
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Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study

Conditions
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Hypoglycemia

Intervention / Treatment
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* Device: experimental


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: device<br>Device implant and EEG recording | Device: experimental<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device performance |  | End of observation |