Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

NCT ID: NCT01745900

Last Updated: 2012-12-10

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

UNKNOWN

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-03-31

Brief Summary

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Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.

Detailed Description

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The objectives of this study are

* collect subject data on a near-infrared spectroscopy-based glucose meter
* evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques
* collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.

Conditions

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Insulin Dependent Diabetes Non Insulin Dependent Diabetes Gestational Diabetes

Keywords

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Diabetes Gestational Diabetes Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Female aged ≥ 18 and ≤ 50 years of age at time of enrollment
* Females with self reported diagnosis of Type I, Type II or Gestational Diabetes, or no self reported diagnosis of diabetes.

Exclusion Criteria

* Severe heart disease as evidenced by peripheral edema (self reported)
* Currently taking Lasix (self reported)
* Liver disease as evidenced by jaundice (self reported)
* Receiving dialysis or having known renal compromise (self reported)
* Skin damage at optical sampling site
* Scars, tattoos, rashes or other disruption/discoloration on the right index finger
* Recent (within past month) or current oral steroid therapy or topical steroids applied to the hands; inhaled steroid therapy (self reported)
* Current chemotherapy, or chemotherapy within the past 12 months (self reported)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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InLight Solutions

INDUSTRY

Sponsor Role collaborator

VeraLight, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amber Brassfield, RN

Role: PRINCIPAL_INVESTIGATOR

Accelovance

Locations

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Accelovance Inc.

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amber Brassfield, RN

Role: CONTACT

Phone: 619-291-2845

Amber Brassfield, RN

Role: CONTACT

Phone: 619-366-1129

Other Identifiers

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VL-240

Identifier Type: -

Identifier Source: org_study_id