Gestational Diabetes, Insulin Dependent Diabetes, Non Insulin Dependent Diabetes
Conditions
Keywords
Diabetes, Gestational Diabetes, Female
Brief summary
Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.
Detailed 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.
Interventions
None listed
Sponsors
InLight Solutions
VeraLight, Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuing validation of near infrared spectroscopy-based glucose meter algorithm | 3 months |
Countries
United States
Contacts
Primary ContactAmber Brassfield, RN
Backup ContactAmber Brassfield, RN
Outcome results
None listed