- Abbott is designing a first-of-its-kind biowearable that will
enable people with diabetes to continuously monitor glucose and
ketones in one sensor
- Device promises to redefine care for people with diabetes who
are at risk for developing a life-threatening complication called
diabetic ketoacidosis
ABBOTT
PARK, Ill., June 3, 2022
/PRNewswire/ -- Abbott (NYSE: ABT) today announced it's developing
a new biowearable that will continuously monitor glucose and ketone
levels in one sensor. The system has secured breakthrough device
designation from the U.S. Food and Drug Administration, which is
designed to expedite the review of innovative technologies that can
improve the lives of people with life-threatening or irreversibly
debilitating diseases or conditions.
"Abbott revolutionized diabetes care with FreeStyle
Libre® technology, which is the number one continuous
glucose monitor used by 4 million people around the world," said
Jared Watkin, senior vice president
of Abbott's diabetes care business. "We're designing our
glucose-ketone monitoring system with superior sensing technology
that will pair with industry-leading insulin pumps to create a
best-in-class solution. We're optimistic that this will be the next
big advancement in diabetes tech and a breakthrough for people with
diabetes, especially those who are at risk of developing diabetic
ketoacidosis."
The glucose-ketone sensor will be the same size as Abbott's
FreeStyle Libre 3 sensor, the world's smallest and
thinnest1,2 continuous glucose monitoring (CGM) sensor,
and will connect to Abbott's digital ecosystem, including personal
and caregiver mobile apps and cloud-based data management software
for remote monitoring by healthcare professionals.
Need for Continuous Glucose-Ketone Monitoring
A
continuous glucose-ketone monitor is especially important for
people with diabetes who may be at higher risk of developing
diabetic ketoacidosis (DKA), a potentially life-threatening
condition when ketone levels rise to dangerous levels in the
blood.
DKA is a growing concern globally.3 In the U.S.
alone, there are hundreds of thousands of emergency room visits and
hospitalization for DKA each year.4 Yet today, few
people with diabetes are regularly monitoring their ketones because
the current methods of testing – typically through blood or urine –
are costly5 and burdensome.6 Adding
continuous ketone monitoring to a continuous glucose monitoring
system eliminates the need for a separate ketone test.
Recent studies show continuous ketone monitoring (CKM) could
help prevent DKA.3 With continuous monitoring, rising
ketone levels can be detected early, as a warning of impending
ketoacidosis, and inform care so that DKA does not develop. Leading
diabetes experts have called for expansion of ketone monitoring,
including its integration with CGM technology in a single
sensor.7,8 Unchecked ketone levels can pose serious
risks for people with diabetes, especially children and young
adults with type 1 diabetes.7
"In my practice, I've seen numerous cases of DKA in teens and
children, which could have been prevented with continuous ketone
monitoring," said Dr. Kurt Midyett,
pediatric endocrinologist and medical director at Midwest Pediatric
Specialists in Overland Park, Kansas. "Bringing people with
diabetes the ability to continuously monitor both glucose and
ketones in a single, intuitive device is an important step forward
in diabetes care, as it will allow patients to detect rising ketone
levels and intervene before full-blown DKA develops."
"DKA remains a critical issue for too many people with type 1
diabetes. We applaud Abbott for tackling this issue—one that JDRF
is also committed to addressing," said Aaron J. Kowalski, Ph.D., chief executive
officer of JDRF. "JDRF supports the development of CGM/CKM systems
like the one Abbott is developing. CGM/CKMs will be key to reducing
DKA incidence in the diabetes population. Additionally, CGM/CKM
devices that can warn of impending DKA will be critical to enabling
the broader adoption and safe, effective use of sodium-glucose
cotransporter (SGLT) inhibitors. SGLT inhibitors improve blood
glucose and are expected to improve heart and kidney outcomes for
people with type 1 diabetes but have been held back because they
increase the risk of DKA."
Availability and Interoperability
Abbott is already
conducting clinical studies on the glucose-ketone monitoring
system. Pivotal trials will take place in 2023 with regulatory
submissions to follow thereafter.
Abbott plans to partner with leading insulin pump manufacturers
to make the dual monitoring system interoperable with insulin
delivery systems.
Abbott currently has the world's most widely used
CGM9. Abbott's FreeStyle Libre portfolio has already
changed the lives of approximately 4 million people across 60
countries9 by providing breakthrough technology that is
accessible and affordable.10
About Abbott
Abbott is a global healthcare leader that
helps people live more fully at all stages of life. Our portfolio
of life-changing technologies spans the spectrum of healthcare,
with leading businesses and products in diagnostics, medical
devices, nutritionals and branded generic medicines. Our 113,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
1Data on file, Abbott Diabetes Care.
2Among patient-applied sensors.
3Cherubini, V., Grimsmann, J.M., Åkesson, K. et al.
Temporal trends in diabetic ketoacidosis at diagnosis of paediatric
type 1 diabetes between 2006 and 2016: results from 13 countries in
three continents. Diabetologia 63, 1530–1541 (2020).
4National Diabetes Statistics Report 2020, Estimates of
Diabetes and Its Burden in the United
States (2020).
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
Accessed May 5, 2022.
5Albanese-O'Neill A, Wu M, Miller KM, et al. Poor
Adherence to Ketone Testing in Patients With Type 1
Diabetes. Diabetes Care. 2017;40(4):e38-e39.
6Dhatariya K. Blood Ketones: Measurement,
Interpretation, Limitations, and Utility in the Management of
Diabetic Ketoacidosis. Rev Diabet Stud.
2016;13(4):217-225.
7Nguyen KT, Xu NY, Zhang JY, et al. Continuous Ketone
Monitoring Consensus Report 2021. Journal of Diabetes Science
and Technology. October 2021.
8Lee MH, Paldus B, Krishnamurthy B, et al. The Clinical
Case for the Integration of a Ketone Sensor as Part of a Closed
Loop Insulin Pump System. J Diabetes Sci Technol.
2019;13(5):967-973.
9Data on file, Abbott Diabetes Care. Data based on the
number of users worldwide for the FreeStyle Libre portfolio
compared to the number of users for other leading personal use,
sensor-based glucose monitoring systems.
10Based on a comparison of list prices of the FreeStyle
Libre portfolio versus competitor CGM systems available worldwide.
The actual cost to patients may or may not be lower than other CGM
systems, depending on local reimbursement, if any.
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SOURCE Abbott