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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hypo-Safe A/S
Sponsor:
Information provided by (Responsible Party):
Hypo-Safe A/S
ClinicalTrials.gov Identifier:
NCT01238016
First received: November 8, 2010
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Hypoglycemia
Device: experimental

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238016

Contacts
Contact: Claus Juhl, MD 0045 60867172

Locations
Denmark
Esbjerg Sygehus Recruiting
Esbjerg, Denmark, 6700
Contact: Claus Juhl, MD         
Sponsors and Collaborators
Hypo-Safe A/S
  More Information

No publications provided

Responsible Party: Hypo-Safe A/S
ClinicalTrials.gov Identifier: NCT01238016     History of Changes
Other Study ID Numbers: H01A03
Study First Received: November 8, 2010
Last Updated: March 7, 2014
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014