Clinical trial NCT01709851: Performance Study to Test the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Intravascular continuous glucose monitoring
Subcutaneous continuous glucose monitoring
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Menarini Group
First posted: 2012-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with type 1 diabetes

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Point Accuracy of the microdialysis signal
timeFrame: 72 hours
Secondary outcomes:
measure: Rate accuracy of the microdialysis signal
timeFrame: 72 hours
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Dept. of Internal Medicine, Endocrinology and Metabolism
Study officials:
affiliation: Medical University of Graz
name: Thomas R. Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References: