Status:
COMPLETED
Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
Menarini Group
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped with the GlucoMen®Day system, over up to 100 hours observation after implantation of the microdialysis probe....
Detailed Description
This is a monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, who will be equipped with the GlucoMen®Day system. Each subject will be investigated for up to 100 hours af...
Eligibility Criteria
Inclusion
- Established diagnosis of type-1-diabetes
- Ability to provide informed consent
- Age 18-75 years
Exclusion
- Subjects under anti-coagulant treatments
- Alcoholism
- Body mass index (BMI) \> 32 kg/m2
- Inability to adhere to the protocol or to attend the required follow- up visits and tests
- Diseases or conditions of the abdominal wall which, in the opinion of Clinician might contraindicate the insertion of the hypodermic needle into the subcutaneous tissue
- Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
- Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
- Subjects currently participating in a clinical study
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01407315
Start Date
November 1 2010
End Date
December 1 2010
Last Update
April 20 2012
Active Locations (1)
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1
Medical University of Graz
Graz, Austria, 8036