Freedom Meditech has received marketing clearance for a device that measures lens autofluorescence without dilation….
Autofluorescence is the natural emission of light by biological structures such as mitochondria and lysosomes when they have absorbed light. Studies have shown that autofluorescence intensity increases with age, and also increases in patients with diabetes. There is a correlation between autofluorescence and diabetes duration and average blood glucose levels in diabetics. There is also a correlation between autofluorescence and diabetes-related disease states like cataracts and retinopathy.
In a study using a device designed by Freedom Meditech, researchers measured the progression of diabetes in patients, but and also attempted to identify subjects with undiagnosed type 2 diabetes. A total of 233 subjects participated in testing the device; 51 were normal subjects with self-reported healthy eyes and 53 had been diagnosed with either type 1 or 2 diabetes and were self-reported to have healthy eyes. Each subject was scanned up to a maximum of 8 times, and the fluorescence intensity values were recorded and reported. The results of the scans show that the device detected type 2 diabetes with a sensitivity of 67% and a specificity of 94%. By comparison, a hemoglobin A1c test displayed a sensitivity of 44% and a specificity of 79%, while a fasting plasma glucose test displayed a sensitivity of 50% and a specificity of 95%.
In conclusion, using lens autofluorescence as a screening tool may be an effective tool for discovering undiagnosed diabetes. The test is rapid (about 6 seconds), noninvasive, and does not require fasting or any type of preparation by the patient. It also eliminates sharps, biohazardous waste, and other materials than need to managed and eliminated.
- New device being marketed can screen subjects for type 2 diabetes.
- Target population for this device includes individuals hesitant about blood draws and those who do not frequently go to a primary care provider.
Cahn, F. et al. "Measurement of Lens Autofluorescence Can Distinguish Subjects With Diabetes From Those Without" Journal of Diabetes Science and Technology. 2014; 8(1): 43-49