title: Measurement of Lens Autofluorescence Can Distinguish Subjects With Diabetes From Those Without.
abstract: Lens autofluorescence is increased in patients with diabetes mellitus, but clinical application has been limited by the lack of an instrument suitable for routine clinical use. We investigate possible uses of a new scanning confocal biomicroscope (1) to identify subjects with undiagnosed type 2 diabetes and (2) as a marker for the progression of diabetes. One hundred seventy-eight subjects self-reported as normal and 53 subjects physician-diagnosed with diabetes or prediabetes were recruited. Measurements were collected using a ClearPath DS-120 Lens Fluorescence Biomicroscope calibrated with standards traceable to National Institute of Standards and Technology (NIST). Fluorescence intensities were corrected for age by subtracting the value expected from a regression of intensity versus age for normal subjects. This "fluorescence deviation" showed progressively higher values for normal, prediabetes, type 2 diabetes, and type 1 diabetes and a high degree of predictability of diabetes diagnosis. A receiver operating characteristics curve was used to determine sensitivity and specificity for prediction of diabetes type 2. At a fluorescence deviation of 2500, a sensitivity of 67% at 94% specificity was observed detection of type 2 diabetes. The progressively higher fluorescence deviations are consistent with the physiological mechanisms of accumulation of fluorescent advanced glycation end products as the subject ages. The sensitivity and specificity performance of the lens autofluorescence test for type 2 diabetes is comparable to the performance of glucose threshold tests. The statistically significant difference between fluorescence deviations of normal and type 2 diabetes supports the feasibility of lens autofluorescence to screen subjects for undiagnosed type 2 diabetes. Ophthalmic practices are points of care at which there may be a public health benefit for screening patients for undiagnosed diabetes.
authors.affiliation: Freedom Meditech Inc, San Diego, CA, USA fcahn@biomedicalstrategies.com.
authors.forename: Frederick
authors.initials: F
authors.lastname: Cahn
authors.affiliation: Freedom Meditech Inc, San Diego, CA, USA.
authors.forename: John
authors.initials: J
authors.lastname: Burd
authors.affiliation: Freedom Meditech Inc, San Diego, CA, USA.
authors.forename: Keith
authors.initials: K
authors.lastname: Ignotz
authors.affiliation: Freedom Meditech Inc, San Diego, CA, USA.
authors.forename: Shardendu
authors.initials: S
authors.lastname: Mishra
keywords: advanced glycation end products (AGEs); biomicroscope; diabetes mellitus; fluorescence deviation; fluorescence ratio; lens autofluorescence; prediabetes