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

Primary Purpose

Hypoglycemia

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
experimental
Sponsored by
UNEEG Medical A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoglycemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Esbjerg Sygehus

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

device

Arm Description

Device implant and EEG recording

Outcomes

Primary Outcome Measures

Device performance

Secondary Outcome Measures

Full Information

First Posted
November 8, 2010
Last Updated
August 16, 2016
Sponsor
UNEEG Medical A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01238016
Brief Title
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study
Acronym
Pilot
Official Title
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Replaced by new study
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNEEG Medical A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The trial aims at measuring the safety and performance of the Hyposafe device.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
device
Arm Type
Other
Arm Description
Device implant and EEG recording
Intervention Type
Device
Intervention Name(s)
experimental
Primary Outcome Measure Information:
Title
Device performance
Time Frame
End of observation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Esbjerg Sygehus
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark

12. IPD Sharing Statement

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

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