A Clinical Study of the C8 MediSensors Optical Glucose Monitor™



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:June 2012
End Date:June 2013
Contact:Vice President, Regulatory, Clinical, Quality
Phone:408-622-2040

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A Clinical Study to Evaluate the Performance of the C8 MediSensors Optical Glucose Monitor™ During On-Site Testing and Real Time Use Monitoring


The purpose of this study is to compare glucose measurements from the C8 MediSensors
non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow
Springs Instrument(YSI) blood glucose analyzer.


This is a prospective, non-randomized, open label study to evaluate the performance of the
C8 MediSensors non-invasive Optical Glucose Monitor™ on individuals with diabetes mellitus.
Capillary blood samples will be obtained throughout a daily study session; the study session
may last for up to 12 hours. Blood glucose will be measured on a YSI blood glucose
analyzer. Subjects may adjust food intake and insulin administration so device performance
is evaluated across a broad range of glucose concentrations. Glucose measurements will be
time matched and paired for comparison. Skin effects and adverse events will be evaluated.

Inclusion Criteria:

1. 18 years of age or older.

2. Understands and agrees to comply with study instructions.

3. Read, understood, signed and dated the Informed Consent Form.

Exclusion Criteria:

1. Pregnancy.

2. Extensive skin changes or diseases that preclude wearing the test device at the
proposed wear site(s) (e.g., extensive psoriasis, recent burns or severe sunburn,
extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).

3. Employed by a company within the diabetes field other than the study sponsor.

4. Medical history or any condition that may, in the opinion of the investigator,
compromise the subject's ability to participate.
We found this trial at
1
site
San Jose, California 95119
?
mi
from
San Jose, CA
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