Hypoglycemia
Conditions
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.
Interventions
DEVICEexperimental
Sponsors
UNEEG Medical A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device performance | End of observation |
Countries
Denmark
Outcome results
None listed