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
Recruitment status was Recruiting
Sponsor:
Hypo-Safe A/S
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypoglycemia Prevention/Detection |
Device: experimental |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment 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:
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| device | Device: experimental |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Claus Juhl, Hyposafe A/S |
| ClinicalTrials.gov Identifier: | NCT01238016 History of Changes |
| Other Study ID Numbers: | H01A03 |
| Study First Received: | November 8, 2010 |
| Last Updated: | June 7, 2011 |
| Health Authority: | Denmark: Danish Medicines Agency |
Additional relevant MeSH terms:
|
Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013