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

This study has been completed.
Sponsor:
Collaborator:
Menarini Group
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01709851
First received: October 11, 2012
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Device: Vascular microdialysis using the GMD-system
Device: Vascular and subcutaneous microdialysis using the GMD-system

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Single-center, Open, Pilot Trial to Investigate the Performance of the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Point Accuracy of the microdialysis signal [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    MARD (mean absolute relative difference), MARE (mean absolute relative error), %Press analysis


Secondary Outcome Measures:
  • Rate accuracy of the microdialysis signal [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    R-EGA (rate error grid analysis) and P-EGA (point error grid analysis)


Enrollment: 12
Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 1 Diabetes - vMD and sMD
Patients will undergo vascular (vMD) and subcutaneous microdialysis (sMD) using the GMD-system (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
Type 1 diabetes - vMD
Patients will undergo vascular microdialysis (vMD) using the GMD-system (GlucoMen(R)Day-system)
Device: Vascular microdialysis using the GMD-system
Glucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with type 1 diabetes

Criteria

Inclusion Criteria:

  • Informed consent obtained after being advised of the nature of the study
  • Male or female aged 18 - 75 years (both inclusive)
  • Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
  • Body mass index 20.0 - 29.5 kg/m² (both inclusive)
  • HbA1c < 86.0mmol/mol

Exclusion Criteria:

  • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods.
  • Skin pathology or condition prohibiting needle insertion as judged by the investigator.
  • History of bleeding disorder.
  • History of heparin-induced thrombocytopenia (HIT)
  • Current participation in another clinical study.
  • Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator.
  • Lipodystrophy
  • Current treatment with systemic (oral or i.v.) corticosteroids or any anticoagulation medication.
  • Blood donation or blood loss of more than 500 mL within 12 weeks prior to the study day.
  • Known hypersensitivity to Fondaparinux sodium (Arixtra®).
  • Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen.

Study day exclusion criteria:

  • Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia.
  • Positive result of alcohol breath test.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709851

Locations
Austria
Medical University of Graz, Dept. of Internal Medicine, Endocrinology and Metabolism
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Menarini Group
Investigators
Principal Investigator: Thomas R. Pieber, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01709851     History of Changes
Other Study ID Numbers: GMD_05
Study First Received: October 11, 2012
Last Updated: April 15, 2013
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Graz:
Type 1 diabetes
Intravascular continuous glucose monitoring
Subcutaneous continuous glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014