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http://dst.sagepub.com/cgi/reprint/1932296814551044v1.pdf?ijkey=0NfrNfDIEsIlbcr&keytype=ref
DPNCheck is a fast, accurate and quantitative point-of-care test for diabetic peripheral neuropathy, or DPN. The DPNCheck test addresses an unmet medical need for better and more cost-effective screening, diagnosing and monitoring of DPN. This complication affects over 50% of people with diabetes and leads to foot ulcers and limb amputation, as well as severe pain and an overall reduction in patient quality of life.
The study by Sharma and colleagues was a single site comparison of DPNCheck with a standardized clinical definition of DPN (Neuropathy Disability Score, NDS) and a validated measure of small fiber neuropathy (Laser Doppler (LDI) Flare). The study enrolled a total of 242 subjects, which included 162 subjects with diabetes (80 Type 1 and 82 Type 2) and 80 healthy controls. Key reported results include:
- DPNCheck sural nerve amplitude and conduction velocity demonstrated high sensitivity and specificity of 0.7 - 0.9 at all stages of neuropathy.
- DPNCheck sural nerve amplitude and conduction velocity were highly correlated to LDIFLARE measurements of small fiber neuropathy.
The study authors concluded that DPNCheck "… has good sensitivity and specificity at the various stages of DPN and correlates well with the LDIFLARE technique. These findings suggest that the device has considerable potential for assessing DPN in diabetes clinics."
"The impressive diagnostic performance of DPNCheck, as reported by
Sharma and colleagues, indicates that it is effective at detecting DPN
at all stages of the disease from mild to advanced neuropathy. There is
no other widely available diagnostic test for DPN with comparable
operating characteristics," said
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