Recruiting

Observational StudyEvaluation and Comparison of Noninvasive Blood Glucose Concentrations

Sponsor:

VeraLight, Inc.

Code:

NCT01745900

Conditions

Insulin Dependent Diabetes

Non Insulin Dependent Diabetes

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Insulin Dependent Diabetes

Non Insulin Dependent Diabetes

Gestational Diabetes

Study ID

NCT01745900

Start date

Dec, 2012

Status verified date

Dec, 2012

Completion date

Mar, 2013

Anticipated

Primary completion date

Mar, 2013

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Continuing validation of near infrared spectroscopy-based glucose meter algorithm [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Amber Brassfield, RN

619-291-2845

Amber Brassfield, RN

619-366-1129

Locations

Accelovance Inc.

Recruiting

San Diego, California, United States, 92108

Principal Investigator:

Amber Brassfield, RN

More Information

Sponsor

VeraLight, Inc.

Last update posted

Dec 10, 2012

Last verified

Dec, 2012

Keywords

Diabetes
Gestational Diabetes
Female

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VeraLight, Inc. on 2012-12-10.