A Clinical Study of the C8 MediSensors Optical Glucose Monitor™

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01726114

Acronym

Spectrum

Enrollment

Registered

2012-11-14

Start date

2012-06-30

Completion date

2013-03-31

Last updated

2013-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes, Diabetes Mellitus, continuous Glucose Monitor

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.

Interventions

DEVICENon-invasive Optical Glucose Monitor™

Test device

DEVICEYSI blood glucose analyzer

Reference device

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026