Know Labs to Present at the American Diabetes Association’s Scientific Sessions
21 Junho 2024 - 7:30PM
Business Wire
Latest clinical research results demonstrate a
stable MARD in an expanded dataset.
Know Labs, Inc. (NYSE American: KNW), a leading developer of
non-invasive medical diagnostic technology, today announced further
interim results from a clinical research study that assessed the
accuracy of Know Labs’ proprietary non-invasive radiofrequency (RF)
dielectric sensor in measuring blood glucose. Participants with
prediabetes and Type 2 diabetes were studied and venous blood was
used as a comparative reference. The study found that the accuracy
of Know Labs’ proprietary sensor in estimating blood glucose values
remained statistically stable, with an expanded dataset and a new
machine learning (ML) model.
Dr. Virend K. Somers of the Mayo Clinic serves as an author and
co-investigator on the clinical research protocol. Dr. Somers will
present an abstract titled, “A New Machine Learning Model and
Expanded Dataset for a Non-Invasive BGM” at the American Diabetes
Association’s 84th Scientific Sessions (ADA) in Orlando, Florida
during a general poster presentation session on Saturday, June 22
at 12:30 PM - 1:30 PM EDT.
This study reflects the latest results in Know Labs’ first
clinical research protocol involving people with diabetes and using
venous blood as a comparative reference. In March of this year,
Know Labs presented early interim results from the same clinical
research protocol at the 17th International Conference on Advanced
Technologies & Treatments for Diabetes (ATTD), in which its
non-invasive blood glucose monitor and ML model trained on data
collected in a lab setting achieved a MARD of 11.1%. Compared to
the previous study, which was based on 10 participants and 650
paired RF and reference blood glucose values, this study involved
more than twice as much data collected from 22 participants
yielding 1,430 paired values.
Study Design
The proprietary RF sensor employed in the study measures glucose
levels using dielectric spectroscopy by rapidly scanning a large
range of RF frequencies and recording voltage values detected at
each frequency to quantify, with trade-secret ML algorithms,
real-time continuous blood glucose levels. The sensor continuously
scanned participants' forearms for up to three hours during a 75g
Oral Glucose Tolerance Test. From the 22 participants, 1,430 venous
blood samples were collected using a peripheral intravenous
catheter and analyzed using an FDA-cleared blood glucose hospital
meter as a reference device.
Data was preprocessed using smoothing techniques and an 80/20
split was performed to create model training and test datasets,
respectively. Know Labs trained a ML model to estimate reference
venous blood glucose values on 80% of the data consisting of 1,143
paired RF device and venous blood glucose values randomly selected
from the total dataset and then tested on the remaining, held-out
20% of data (287 paired values).
Results
On the held-out test dataset, blood glucose was estimated with a
MARD of 11.8% ± 1.5% relative to venous blood. It performed
similarly on normoglycemic (12.1% ± 1.8%) and hyperglycemic (11.0%
± 2.3%) ranges.
Compared to the previous results presented in March, the MARD of
11.8% is not statistically significantly different, nor were the
results in the hyperglycemic range (>180 mg/dL) and
normoglycemic range (70 to 180 mg/dL), indicating stability in
accuracy.
These interim results are part of a larger, now completed
clinical study with over 30 participants, conducted September 2023
through February 2024. As the Company continues on the path toward
FDA clearance, Know Labs will deploy the recently announced KnowU™
wearable non-invasive continuous glucose monitor in ongoing
clinical and bench studies. The wearable form factor of the KnowU
device allows these studies to evaluate the technology’s
performance throughout continuous wear, in ‘real-world’
environments outside of the lab where new elements of interference
are likely, and within more extreme glycemic ranges (below 70 mg/dL
and above 350 mg/dL). As new data is collected in these areas and
additional variables come into play, the Company will make
necessary refinements to the device and accompanying algorithms. To
stay updated on the latest clinical research results, visit
www.knowlabs.co/research-and-development.
About Know Labs, Inc.
Know Labs, Inc. is a public company whose shares trade on the
NYSE American Exchange under the stock symbol “KNW.” The Company’s
platform technology uses spectroscopy to direct electromagnetic
energy through a substance or material to capture a unique
molecular signature. The technology can be integrated into a
variety of wearable, mobile or bench-top form factors. This
patented and patent-pending technology makes it possible to
effectively identify and monitor analytes that could only
previously be performed by invasive and/or expensive and
time-consuming lab-based tests. The first application of the
technology will be in a product marketed as a non-invasive glucose
monitor. The device will provide the user with accessible and
affordable real-time information on blood glucose levels. This
product will require U.S. Food and Drug Administration clearance
prior to its introduction to the market.
Safe Harbor Statement
This release contains statements that constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. These statements appear in a number of places in this
release and include all statements that are not statements of
historical fact regarding the intent, belief or current
expectations of Know Labs, Inc., its directors or its officers with
respect to, among other things: (i) financing plans; (ii) trends
affecting its financial condition or results of operations; (iii)
growth strategy and operating strategy; and (iv) performance of
products. You can identify these statements by the use of the words
“may,” “will,” “could,” “should,” “would,” “plans,” “expects,”
“anticipates,” “continue,” “estimate,” “project,” “intend,”
“likely,” “forecast,” “probable,” “potential,” and similar
expressions and variations thereof are intended to identify
forward-looking statements. Investors are cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties, many of which are beyond Know
Labs, Inc.’s ability to control, and actual results may differ
materially from those projected in the forward-looking statements
as a result of various factors. These risks and uncertainties also
include such additional risk factors as are discussed in the
Company’s filings with the U.S. Securities and Exchange Commission,
including its Annual Report on Form 10-K for the fiscal year ended
September 30, 2023, Forms 10-Q and 8-K, and in other filings we
make with the Securities and Exchange Commission from time to time.
These documents are available on the SEC Filings section of the
Investor Relations section of our website at www.knowlabs.co. The
Company cautions readers not to place undue reliance upon any such
forward-looking statements, which speak only as of the date made.
The Company undertakes no obligation to update any forward-looking
statement to reflect events or circumstances after the date on
which such statement is made.
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version on businesswire.com: https://www.businesswire.com/news/home/20240621168344/en/
For Know Labs Media Inquiries: Matter Health Abby Mayo
Knowlabs@matternow.com Ph. (617) 272-0592
Know Labs, Inc.: Jess English jess@knowlabs.co Ph. (646)
912-2024
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