NCT01726114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

October 31, 2012

Last Update Submit

March 23, 2013

Conditions

Diabetes Mellitus

Keywords

DiabetesDiabetes Mellituscontinuous Glucose Monitor

Outcome Measures

Primary Outcomes (1)

  • Performance of the test device in comparison to the reference device

    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.

    6 months

Study Arms (1)

Non-invasive Optical Glucose Monitor™

EXPERIMENTAL

Test device

Device: Non-invasive Optical Glucose Monitor™Device: YSI blood glucose analyzer

Interventions

Non-invasive Optical Glucose Monitor™DEVICE

Test device

Also known as: Continuous glucose monitor
Non-invasive Optical Glucose Monitor™
YSI blood glucose analyzerDEVICE

Reference device

Also known as: Yellow Springs Instruments (YSI) blod glucose analyzer
Non-invasive Optical Glucose Monitor™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older.
  • Understands and agrees to comply with study instructions.
  • Read, understood, signed and dated the Informed Consent Form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

C8 MediSensors, Inc.

San Jose, California, 95119, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vice President, Clincal, Regulatory, Quality

    C8 MediSensors, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 14, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 26, 2013

Record last verified: 2013-03

Locations

US(1)