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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C8 MediSensors, Inc.
ClinicalTrials.gov Identifier:
NCT01726114
First received: October 31, 2012
Last updated: March 23, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Device: Non-invasive Optical Glucose Monitor™
Device: YSI blood glucose analyzer

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Clinical Study to Evaluate the Performance of the C8 MediSensors Optical Glucose Monitor™ During On-Site Testing and Real Time Use Monitoring

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by C8 MediSensors, Inc.:

Primary Outcome Measures:
  • Performance of the test device in comparison to the reference device [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 86
Study Start Date: June 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-invasive Optical Glucose Monitor™
Test device
 Device: Non-invasive Optical Glucose Monitor™
Test device
Other Name: Continuous glucose monitor
Device: YSI blood glucose analyzer
Reference device
Other Name: Yellow Springs Instruments (YSI) blod 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726114

Locations
United States, California
C8 MediSensors, Inc.
San Jose, California, United States, 95119
Sponsors and Collaborators
C8 MediSensors, Inc.
Investigators
Principal Investigator: Vice President, Clincal, Regulatory, Quality C8 MediSensors, Inc.
  More Information

No publications provided

Responsible Party: C8 MediSensors, Inc.
ClinicalTrials.gov Identifier: NCT01726114     History of Changes
Other Study ID Numbers: C8CSP_19042012
Study First Received: October 31, 2012
Last Updated: March 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by C8 MediSensors, Inc.:
Diabetes
Diabetes Mellitus
continuous Glucose Monitor

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013