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Performance Study to Test the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes

NCT01709851 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2013-04-16

No results posted yet for this study

Summary

Over the last years, a number of systems for continuous subcutaneous glucose monitoring have been marketed and are routinely used in patients with diabetes to obtain more detailed information about 24-hour glucose profiles.

In the hospital, numerous factors influencing glycemic control and possibly leading to glucose excursions out of the desired range exist, e.g. interventions for which the patient has to remain fasting or medications such as corticosteroids or vasopressors. A reliable continuous glucose signal could help to observe levels of glycaemia not only at defined time-points but continuously, making it possible for physicians and nursing staff to better adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo- or hyperglycaemia.

In the hospital setting, vascular access is granted in the majority of patients and could as well be used as an alternative site for continuous glucose monitoring.

The aim of the present study is to assess accuracy of the glucose data obtained by means of an intravascular microdialysis-based CGM system against venous blood glucose reference measurements.

Conditions

Interventions

DEVICE

Vascular microdialysis using the GMD-system

Glucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system

DEVICE

Vascular and subcutaneous microdialysis using the GMD-system

Glucose levels will be monitored by means of vascular and subcutaneous microdialysis using the GlucoMen(R)Day system

Sponsors & Collaborators

  • Menarini Group

    collaborator INDUSTRY

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Thomas R. Pieber, MD · Medical University of Graz

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2012-12-31
Completion
2013-04-30

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709851 on ClinicalTrials.gov