Diabetic Peripheral Neuropathy Screening That Includes DPNCheck® Predicts Mortality In A Prospective Clinical Study
07 Junio 2023 - 8:00AM
NeuroMetrix, Inc. (Nasdaq: NURO) noted presentation of new clinical
data at the Diabetes UK meeting held April 23-26 in Liverpool, UK.
The scientific poster was titled "Abnormal combined diabetic
peripheral neuropathy (DPN)-check and SUDOSCAN results predict
all-cause mortality in people with diabetes: The Sheffield
prospective study."
The study prospectively followed 245 individuals
with diabetes for 7-years following screening for peripheral
neuropathy. The screening tests included a structured clinical exam
(Toronto Clinical Neuropathy Score, TCNS), the Semmes-Weinstein
Monofilament test (10 g-MFT) that is a subjective, clinical test
for DPN, a device (Sudoscan®) that measures autonomic nerve
function, and DPNCheck. DPNCheck and Sudoscan are complementary
validated point-of-care tests for DPN. The initial cross-sectional
screening results were previously published and showed that
DPNCheck was the most accurate individual test for DPN.
As reported in the Diabetes UK poster, after
adjusting for age, HbA1c and total cholesterol, only abnormal
results from DPNCheck and Sudoscan were significantly associated
with all-cause mortality (HR=1.18, p=0.04) after 7-years. The study
authors concluded, "This is the first prospective study to show
abnormal combined DPN-Check and Sudoscan results predict all-cause
mortality, even after adjustment for other risk factors. However,
the 10 g-MFT and TCNS that diagnose DPN late did not in this
unselected population." The poster is available online.
Shai N. Gozani, M.D., Ph.D., CEO of NeuroMetrix
commented, "This landmark study from the renowned University of
Sheffield diabetes research group shows that only objective
assessments of DPN are predictive of mortality. The implication is
that early stage DPN puts the patient at risk for devastating
health complications. However, early detection and intervention
have the potential to alter the patient's disease trajectory. We
look forward to learning from the University of Sheffield team what
combination of DPNCheck results provide the highest predictive
value so that this information can be communicated to the thousands
of clinics worldwide that use DPNCheck."
Dr. Gozani continued, "Another important result
is that simple monofilament testing, which has been a mainstay of
DPN screening for decades, is not predictive of mortality; likely
due to its subjective nature and inability to detect early nerve
changes indicative of DPN. While the monofilament has been useful
for detection of late stage manifestations of DPN, we are now in an
era of precision and preventative medicine enabled by technologies
such as rapid genetic screening and in-office PCR testing for
pathogens. It no longer makes sense to detect peripheral neuropathy
in diabetes patients using a simplistic subjective test when
gold-standard technology in the form of DPNCheck is available and
cost-effective at the point-of-care."
About Diabetic Peripheral
Neuropathy
Diabetic peripheral neuropathy (DPN) is the most
common long-term complication of diabetes, affecting half of people
with diabetes, The clinical and economic burden of DPN stems from
its central role in the development of foot ulcers that can lead to
lower extremity amputation. DPN also causes debilitating chronic
nerve pain and altered proprioception that increases the risk of
falling, particularly in the elderly. Overall, DPN is associated
with a substantial reduction in quality of life and decreased
activities of daily living.
About DPNCheck
DPNCheck is an automated, fast, accurate, and
quantitative sural nerve conduction test used to evaluate
peripheral neuropathies. It is designed to be used by clinicians at
the point-of-care to detect peripheral neuropathies at an early
stage when intervention is likely to be most effective, to stage
the severity of nerve deterioration and to monitor disease
progression and treatment benefits. Please visit at dpncheck.com
for more information.
About NeuroMetrix
NeuroMetrix is an innovation-driven company with
a mission to improve individual and population health through novel
medical devices and technology solutions for neurological disorders
and pain syndromes. The Company has three commercial products.
Quell® is a prescription wearable neuromodulator that is the only
FDA-authorized medical device to help reduce the symptoms of
fibromyalgia. DPNCheck® is a diagnostic device that provides rapid,
point-of-care detection of peripheral neuropathies. ADVANCE® is a
legacy diagnostic device that provides automated, in-office nerve
conduction studies for the evaluation of focal neuropathies. For
more information, visit www.neurometrix.com.
Source: NeuroMetrix, Inc.
Thomas T. HigginsSVP and Chief Financial
Officerneurometrix.ir@neurometrix.com
NeuroMetrix (NASDAQ:NURO)
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