Evaluation and Comparison of Noninvasive Blood Glucose Concentrations

Gestational Diabetes Clinical Trial

Official title:

An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01745900
• Other study ID #: VL-240
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2012
• Last updated: December 6, 2012
• Start date: December 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2012
• Source: VeraLight, Inc.
• Contact: Amber Brassfield, RN
• Phone: 619-291-2845
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes
• Insulin Dependent Diabetes
• Non Insulin Dependent Diabetes

Locations

Country	Name	City	State
United States	Accelovance Inc.	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
VeraLight, Inc.	InLight Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuing validation of near infrared spectroscopy-based glucose meter algorithm		3 months	No