Status:
WITHDRAWN
Prevention of Severe Hypoglycaemia With Hypo-Safe Hypoglycaemia Alarm Device
Lead Sponsor:
UNEEG Medical A/S
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Hypoglycaemia is the most common acute complication in insulin-treated diabetes. The fear of hypoglycaemia discourages diabetic subjects from the attempt to maintain tight glycemic control, which in t...
Detailed Description
The near-normalization of glycemic control has become an established treatment goal in diabetes in order to reduce the risk of late complications such as nephropathy, neuropathy, retinopathy and cardi...
Eligibility Criteria
Inclusion
- 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 (Appendix 8) 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01178476
Start Date
November 1 2009
End Date
March 1 2011
Last Update
March 10 2014
Active Locations (1)
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1
Hillerød Sygehus
Hillerød, Denmark, 3400