A Clinical Study of the C8 MediSensors Optical Glucose Monitor™

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Non-invasive Optical Glucose Monitor™; Device: YSI blood glucose analyzer

• Registration Number: NCT01726114
• Lead Sponsor: C8 MediSensors, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-14
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-23
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-invasive Optical Glucose Monitor™	Non-invasive Optical Glucose Monitor™	Test device
Non-invasive Optical Glucose Monitor™	YSI blood glucose analyzer	Test device

Primary Outcome Measures

Name	Time	Method
Performance of the test device in comparison to the reference device	6 months	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.

Trial Locations

Locations (1)

C8 MediSensors, Inc.; 🇺🇸 San Jose, California, United States