Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Accuracy of the GlucoMenDay
Study Overview
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. Different meal/hypo procedures will be performed at the study centre.
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 after implantation of the microdialysis probe.
In order to verify the clinical effectiveness of the GlucoMenDay the subjects will be asked to perform a total of six self testing measurements per day using the GlucoCard G-Meter according to the following scheme:
- before breakfast
- before lunch
- 60-120 minutes after lunch
- before dinner
- 60-120 minutes after dinner
- at 3 AM
Subjects will be asked to come to the research facility every day to obtain a venous blood sample and to check system functioning.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Established diagnosis of type-1-diabetes
- •Ability to provide informed consent
- •Age 18-75 years
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Accuracy of the GlucoMenDay
Time Frame: 1 week
Assessed by methods such as the Clarke Error Grid Analysis (EGA), CG-EGA, MARD, MAD
Secondary Outcomes
- Safety of the GlucoMenDay System(1 week)
Investigators
Pieber Thomas, MD
MD, Prof. of Medicine
Medical University of Graz