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Prevention of Severe Hypoglycaemia With Hypo-Safe Hypoglycaemia Alarm Device

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hypo-Safe A/S
ClinicalTrials.gov Identifier:
NCT01178476
First received: November 18, 2009
Last updated: August 9, 2010
Last verified: August 2010
History of Changes
  Purpose

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 turn leads to increased diabetes related morbidity and mortality.

Neuroglycopenic hypoglycaemia in insulin-treated diabetic patients is associated with characteristic changes in EEG with a decrease in alpha activity and an increase in delta and theta activity. We have recently demonstrated that hypoglycaemia-associated EEG-changes can be recorded from subcutaneously placed electrodes using an automated mathematical algorithm based on non-linear spectral analysis. Experimental findings hold promises that an alarm, given at the time of EEG-changes, can help the patients to avoid severe hypoglycaemia by ingestion of carbohydrate.

This is the first larger scale trial testing the clinical applicability of a hypoglycaemia-alarm based on real-time analysis of EEG-signals.


Condition Intervention
Type 1 Diabetes
 Device: Hyposafe Hypoglycaemia alarm device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Severe Hypoglycaemia With Hypo-Safe Hypoglycaemia Alarm Device

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hypo-Safe A/S:

Primary Outcome Measures:
  • The frequency of severe hypoglycaemia event [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The frequency of clinical hypoglycaemia (sensation of hypoglycaemia and BG<3.5mmol/l), biochemical hypoglycaemia (BG<3.5mmol/l), and nocturnal hypoglycaemia (waking up with a sensation of hypoglycaemia and BG<3.5mmol/l) [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyposafe Hypoglycemia alarm device
EEG based hypoglycemia detection
 Device: Hyposafe Hypoglycaemia alarm device
An EEG based hypoglycemia alarm is tested against standard glucose measurement on the risk of severe hypoglycemia
Active Comparator: Regular glucose control
Regular glucose control group
 Device: Hyposafe Hypoglycaemia alarm device
An EEG based hypoglycemia alarm is tested against standard glucose measurement on the risk of severe hypoglycemia

  Show Detailed Description

  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 (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178476

Locations
Denmark
Hillerød Sygehus
Hillerød, Denmark, 3400
Sponsors and Collaborators
Hypo-Safe A/S
Investigators
Principal Investigator: Birger Thorsteinsson, MD. Medical Department, Hillerød Sygehus
  More Information

No publications provided

Responsible Party: Rasmus Stig Jensen, Hypo-Safe A/S
ClinicalTrials.gov Identifier: NCT01178476     History of Changes
Other Study ID Numbers: Hyposafe-hypo-02
Study First Received: November 18, 2009
Last Updated: August 9, 2010
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013