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

UNEEG medical

Status: Terminated

Conditions: Hypoglycemia

Treatments: Device: experimental

Study type: Interventional

Funder types: Industry

Identifiers

NCT01238016

H01A03

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

device

Other group

Description:

Device implant and EEG recording

Treatment:

Device: experimental