N/A
Completed N=18
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT02402153 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Performance: EEG Recordings - Impedance — 2.3 Impedance (kOhm)
Summary
The objective of this pilot trial is to demonstrate the safety and the performance of the Hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance: EEG Recordings - Impedance |
2.3 | — |
| PRIMARY Performance: EEG Quality |
0.4 | — |
| PRIMARY Performance: Continuous EEG |
20.3 | — |
| SECONDARY Usability: Reported Discomfort During Day While Wearing the Device |
4.1 | — |
| SECONDARY Usability: Reported Discomfort During Night While Wearing the Device |
3.8 | — |
| SECONDARY Usability: Reported Discomfort Related to the Implant in the Beginning of the Study |
3.8 | — |
| SECONDARY Usability: Reported Discomfort Related to the Implant at the End of the Study |
4.3 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects
- Age 18-70 years
- 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
- Uraemia defined as s-creatinine above 3 times upper reference value
- Liver disease defined as s-alanine aminotransferase (s-ALAT) above 3 times upper reference interval
- Epilepsy
- Use of antiepileptic drugs for any purposes
- Clinical important hearing impairment
- Use of active implantable medical device including
- Pacemaker and Implantable Cardioverter Defibrillator (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 neuro-active substances
- Infection at the site of device-implantation
- Any haemorrhagic disease
- Diving (snorkel diving allowed) or parachute jumping
- Patients that are judged incapable to understand the patient information or who are unlikely to complete the investigation for any reason
- Persons operating MRI scanners.
- Persons operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military).
- Persons working at broadcast stations for television or FM/DAB radio.
- Persons performing extreme sport.
Data sourced from ClinicalTrials.gov (NCT02402153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.