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

This study has been terminated.
(Replaced by new study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238016
First Posted: November 10, 2010
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hypo-Safe A/S
  Purpose
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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238016


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

Responsible Party: Hypo-Safe A/S
ClinicalTrials.gov Identifier: NCT01238016     History of Changes
Other Study ID Numbers: H01A03
First Submitted: November 8, 2010
First Posted: November 10, 2010
Last Update Posted: August 17, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases