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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Vascular and subcutaneous microdialysis using the GMD-system; Device: Vascular microdialysis using the GMD-system

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz, Dept. of Internal Medicine, Endocrinology and Metabolism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with type 1 diabetes

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point Accuracy of the microdialysis signal	MARD (mean absolute relative difference), MARE (mean absolute relative error), %Press analysis	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate accuracy of the microdialysis signal	R-EGA (rate error grid analysis) and P-EGA (point error grid analysis)	72 hours

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Menarini Group
• Investigators: Principal Investigator: Thomas R. Pieber, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimate): October 18, 2012

Study Record Updates

• Last Update Posted (Estimate): April 16, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Intravascular continuous glucose monitoring; Subcutaneous continuous glucose monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: GMD_05