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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01238016 |
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Date of registration:
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08/11/2010 |
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Primary sponsor: |
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Public title:
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Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study
Pilot |
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Scientific title:
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Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01238016 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Primary Purpose: Basic Science
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Claus Juhl, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Claus Juhl, MD |
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Address:
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Telephone:
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0045 60867172 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypoglycemia Prevention/Detection
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Intervention(s)
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Device: experimental
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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