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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01238016
Other study ID # H01A03
Secondary ID
Status Terminated
Phase N/A
First received November 8, 2010
Last updated August 16, 2016
Start date November 2010
Est. completion date August 2014

Study information

Verified date August 2016
Source Hypo-Safe A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date August 2014
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Device:
experimental


Locations

Country Name City State
Denmark Esbjerg Sygehus Esbjerg

Sponsors (1)

Lead Sponsor Collaborator
Hypo-Safe A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Device performance End of observation Yes
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