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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hypo-Safe A/S.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hypo-Safe A/S
ClinicalTrials.gov Identifier:
NCT01238016
First received: November 8, 2010
Last updated: June 7, 2011
Last verified: November 2010
History of Changes

November 8, 2010
June 7, 2011
November 2010
December 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01238016 on ClinicalTrials.gov Archive Site
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Not Provided
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Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study

The trial aims at measuring the safety and performance of the Hyposafe device. 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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Primary Purpose: Basic Science
Hypoglycemia Prevention/Detection
Device: experimental
device
Intervention: Device: experimental
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
March 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
Both
18 Years to 70 Years
No
Contact: Claus Juhl, MD 0045 60867172
Denmark
 
NCT01238016
H01A03
No
Claus Juhl, Hyposafe A/S
Hypo-Safe A/S
Not Provided
Not Provided
Hypo-Safe A/S
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP