Freedom Meditech Announces Lens Autofluorescence Clinical Study Published in the Journal for Diabetes Science and Technology
In study, non-invasive lens autofluorescence was comparable to gold standard hemoglobin A1c and fasting plasma glucose tests to distinguish if a person had diabetes
SAN DIEGO, Feb. 12, 2014 /PRNewswire/ — Freedom Meditech today announced the publication of a study comparing measurement of lens autofluorescence to current hemoglobin A1c and fasting plasma glucose tests. Using a non-invasive six-second eye scan, researchers found a statistically significant difference in autofluorescence levels between normal glucose levels and glucose levels indicative of type 2 diabetes. The study, entitled “Measurement of Lens Autofluorescence Can Distinguish Subjects with Diabetes from Those Without,” was published in the January edition of the Journal of Diabetes Science and Technology.
The study observed 180 subjects self-reported as normal (not having diabetes) and 53 subjects diagnosed with diabetes or prediabetes. Measurements of autofluorescence, collected using a Lens Fluorescence Biomicroscope calibrated with standards traceable to National Institute of Standards and Technology (NIST), detected type 2 diabetes with a sensitivity of 67% and a specificity of 94%. By comparison, the hemoglobin A1C test demonstrated detection with a sensitivity of 44% and a specificity of 79%, and a fasting plasma glucose test demonstrated a sensitivity of 50% and a specificity of 95%.
“A lens autofluorescence test takes six seconds, is non-invasive and does not require fasting. Furthermore, standard blood tests require blood draw and assay materials, and creates biohazard waste,” added Dr. John Burd, Chief Science Officer at Freedom Meditech. “A lens autofluorescence test may benefit individuals with an aversion to blood draw and those that do not frequently visit their primary physician. We see great opportunities for growth within eye care, integrated delivery networks and corporate health and wellness programs where the patient populations are enriched for undiagnosed diabetes.”
Autofluorescence detects the presence of advanced glycation products, or AGEs, in the lens of the eye. AGEs are yellow-brown and fluorescent proteins that are modified when sugars are metabolized. In the crystalline lens of the eye, AGEs are long-lived and accumulate over time. Studies have shown that AGEs are correlated with uncontrolled glucose.
The data showed a high degree of predictability for diabetes diagnoses from lens autofluorescence measures and progressively higher fluorescence deviations for the diagnoses of prediabetes or diabetes. The progression was consistent with certain physiological mechanisms associated with the aging process and systemic disease, including progression of advanced glycation end products (AGEs), in subjects with prediabetes or diabetes than those without diabetes or prediabetes. The authors used a receiver operating characteristics curve (ROC) analysis to determine sensitivity and specificity for prediction of type 2 diabetes.
The journal article is available online at www.jdst.org.
About Freedom Meditech
Freedom Meditech, Inc. is a medical device company focused on the commercialization of novel ophthalmic technologies for the detection of disease and management of patient health. The company’s first product, the ClearPath DS-120(TM), a non-invasive tool for the measurement of autofluorescence in the eye has been cleared by the FDA, and has obtained the CE mark and a Canadian Establishment license. I-SugarX is the company’s second product currently in development as a non-invasive ophthalmic glucose monitor that measures glucose levels in the eye for people with diabetes. The company maintains corporate and engineering operations in San Diego, CA with supporting research and development activities throughout the state of Ohio. For more information, visit www.freedom-meditech.com or find us on Twitter, Facebook and LinkedIn.
SOURCE Freedom Meditech