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

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.

Study Overview

• Status: Terminated
• Conditions: Hypoglycemia
• Intervention / Treatment: Device: experimental

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark, 6700
    • Esbjerg Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Healthy control subjects or and

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: device; Device implant and EEG recording	Device: experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Device performance	End of observation

Collaborators and Investigators

• Sponsor: UNEEG Medical A/S

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (ESTIMATE): November 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: H01A03