A Clinical Study of the C8 MediSensors Optical Glucose Monitor™

NCT ID: NCT01726114

Last Updated: 2013-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-03-31

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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Non-invasive Optical Glucose Monitor™

Test device

Group Type EXPERIMENTAL

Non-invasive Optical Glucose Monitor™

Intervention Type DEVICE

Test device

YSI blood glucose analyzer

Intervention Type DEVICE

Reference device

Interventions

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Non-invasive Optical Glucose Monitor™

Test device

Intervention Type DEVICE

YSI blood glucose analyzer

Reference device

Intervention Type DEVICE

Other Intervention Names

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Continuous glucose monitor Yellow Springs Instruments (YSI) blod glucose analyzer

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C8 MediSensors, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vice President, Clincal, Regulatory, Quality

Role: PRINCIPAL_INVESTIGATOR

C8 MediSensors, Inc.

Locations

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C8 MediSensors, Inc.

San Jose, California, United States

Site Status

Countries

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United States

Other Identifiers

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C8CSP_19042012

Identifier Type: -

Identifier Source: org_study_id

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