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

Hypoglycemia Clinical Trial

— Pilot  

Official title:

Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01238016
• Other study ID #: H01A03
• Status: Terminated
• Phase: N/A
• First received: November 8, 2010
• Last updated: August 16, 2016
• Start date: November 2010
• Est. completion date: August 2014

Study information

• Verified date: August 2016
• Source: Hypo-Safe A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Device:
• experimental

Locations

Country	Name	City	State
Denmark	Esbjerg Sygehus	Esbjerg

Sponsors (1)

Lead Sponsor	Collaborator
Hypo-Safe A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device performance		End of observation	Yes