A Clinical Study of the C8 MediSensors Optical Glucose Monitor™

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Non-invasive Optical Glucose Monitor™
* Device: YSI blood glucose analyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Understands and agrees to comply with study instructions. Read, understood, signed and dated the Informed Consent Form. Exclusion Criteria: Pregnancy. 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). Employed by a company within the diabetes field other than the study sponsor. Medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-invasive Optical Glucose Monitor™<br>Test device | Device: Non-invasive Optical Glucose Monitor™<br>* Test device<br>* Other names: Continuous glucose monitor;Device: YSI blood glucose analyzer<br>* Reference device<br>* Other names: Yellow Springs Instruments (YSI) blod glucose analyzer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the test device in comparison to the reference device | The primary objective is to characterize the accuracy of the non-invasive glucose measurements from the Optical Glucose Monitor™ to blood glucose measurements on a sample size of approximately 30 subjects with 1000 time matched, paired data points. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Diabetes Mellitus, continuous Glucose Monitor