A Clinical Study of the C8 MediSensors Optical Glucose Monitor™ (Spectrum)

C8 MediSensors

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: YSI blood glucose analyzer

Device: Non-invasive Optical Glucose Monitor™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01726114

C8CSP_19042012

Details and patient eligibility

About

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.

Full description

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.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.