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

This study has been terminated.
(Replaced by new study)
Information provided by (Responsible Party):
Hypo-Safe A/S Identifier:
First received: November 8, 2010
Last updated: August 16, 2016
Last verified: August 2016
The trial aims at measuring the safety and performance of the Hyposafe device.

Condition Intervention
Hypoglycemia Device: experimental

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study

Resource links provided by NLM:

Further study details as provided by Hypo-Safe A/S:

Primary Outcome Measures:
  • Device performance [ Time Frame: End of observation ]

Enrollment: 16
Study Start Date: November 2010
Study Completion Date: August 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Device implant and EEG recording
Device: experimental

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01238016

Esbjerg Sygehus
Esbjerg, Denmark, 6700
Sponsors and Collaborators
Hypo-Safe A/S
  More Information

Responsible Party: Hypo-Safe A/S Identifier: NCT01238016     History of Changes
Other Study ID Numbers: H01A03
Study First Received: November 8, 2010
Last Updated: August 16, 2016

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases processed this record on September 19, 2017