ABBOTT PARK, Ill. and SAN
DIEGO, June 29, 2020
/PRNewswire/ -- Abbott (NYSE: ABT) and Tandem Diabetes Care
(NASDAQ: TNDM) announced today that they have finalized an
agreement to develop and commercialize integrated diabetes
solutions that combine Abbott's world-leading1
continuous glucose monitoring (CGM) technology with Tandem's
innovative insulin delivery systems to provide more options for
people to manage their diabetes. The companies first announced
their intention to work together in October
2019, and this resulting agreement covers the technical
development of device integration and associated commercial support
activities.
"We're excited to integrate our insulin delivery systems with
Abbott's glucose-sensing technology, and we look forward to
expanding options for our customers so that they can combine
devices that best suit their personal needs," said John Sheridan, president and CEO of Tandem
Diabetes Care. "We are proud to have an insulin pump capable of
remote software updates that can make access to future integrations
possible for in-warranty t:slim X2 users at the time of release
without requiring a new pump."
The need for interoperability between diabetes devices is widely
recognized. Tandem's t:slim X2™ insulin pump was the first to
receive U.S. Food and Drug Administration (FDA) clearance in a new
device category called alternate controller enabled (ACE) infusion
pumps in 2019. The special controls for ACE pumps allow for
reliable and secure communication with compatible external devices.
Abbott's FreeStyle Libre 2 integrated continuous glucose monitoring
(iCGM) system was recently cleared by the FDA for adults and
children (4 years and older). Through this collaboration, Abbott
and Tandem will work to digitally connect their technologies for
future automated insulin delivery systems, which will provide
people with options to tailor and simplify how they manage their
diabetes.2
"Abbott is working with our partners to bring integrated
technologies at an affordable price for people with diabetes who
rely on using insulin pumps," said Jared
Watkin, senior vice president, Diabetes Care, Abbott. "By
combining our glucose sensing technology with Tandem's proven
insulin delivery systems, we will be able to create a cohesive
ecosystem for people with diabetes that can fit easily into their
daily lives."
The companies will focus initial commercial activities in the
U.S. and Canada with additional
geographies considered in the future.
About the FreeStyle Libre 2 System
Abbott's FreeStyle
Libre 2 system was recently cleared by the U.S. Food and Drug
Administration (FDA) as an integrated continuous glucose monitoring
(iCGM) system for adults and children ages 4 and older with
diabetes. It is the only iCGM system with optional real-time
alarms3 that measures glucose levels every minute,
meeting the highest level of accuracy standards.4 The
FreeStyle Libre 2 next-generation sensor is worn on the back of the
upper arm for up to 14 days and with a one-second scan using a
handheld reader, users can see their glucose reading, trend arrow
and eight-hour history.
As the #1 sensor-based glucose monitoring system used in the
U.S. and worldwide,5 Abbott's FreeStyle Libre portfolio
has changed the lives of more than 2 million people across 50
countries by providing breakthrough technology that is accessible
and affordable.6 Abbott has secured partial or full
reimbursement for the FreeStyle Libre system in 36 countries,
including Canada, France, Germany, Japan, the United
Kingdom and the U.S.
Indications and Important Safety Information – FreeStyle
Libre 2 System
The FreeStyle Libre 2 Flash Glucose
Monitoring System is a continuous glucose monitoring (CGM) device
with real-time alarms capability indicated for the management of
diabetes in persons age 4 and older. It is intended to replace
blood glucose testing for diabetes treatment decisions, unless
otherwise indicated.
The System also detects trends and tracks patterns and aids in
the detection of episodes of hyperglycemia and hypoglycemia,
facilitating both acute and long-term therapy adjustments.
Interpretation of the System readings should be based on the
glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with
digitally connected devices. The System can be used alone or in
conjunction with these digitally connected devices where the user
manually controls actions for therapy decisions.
WARNINGS/LIMITATIONS*:
The System must not be used with automated insulin dosing (AID)
systems, including closed loop and insulin suspend systems. Remove
the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do
not take high doses of vitamin C (more than 500 mg per day), as
this may falsely raise your Sensor readings. Failure to use the
System according to the instructions for use may result in missing
a severe low blood glucose or high blood glucose event and/or
making a treatment decision that may result in injury. If glucose
alarms and readings from the System do not match symptoms or
expectations, use a fingerstick blood glucose value to make
diabetes treatment decisions. Seek medical attention when
appropriate and contact Abbott Toll
Free (855-632-8658) or
visit* www.freestylelibre.us for detailed indications for
use and safety information.
*Please refer to www.freestylelibre.us for the indications
and important safety information.
About the t:slim X2 Insulin Pump
The t:slim X2 pump
was the first insulin pump classified by the FDA in a new device
category called alternate controller enabled (ACE) infusion
pumps7 and the first system approved as compatible with
interoperable continuous glucose monitoring (iCGM) devices. The
system includes advanced features like a large color touchscreen,
rechargeable battery, Bluetooth® wireless
technology, USB connectivity and watertight construction
(IPX7).8 It is capable of remote software updates using
a personal computer, offering the potential for in-warranty users
to access new features as they become available.9
Indications and Important Safety Information – t:slim
X2 Insulin Pump
RX ONLY. The t:slim X2 insulin pump with
interoperable technology is an alternate controller enabled (ACE)
pump that is intended for the subcutaneous delivery of insulin, at
set and variable rates, for the management of diabetes mellitus in
people requiring insulin. The pump is able to reliably and securely
communicate with compatible, digitally connected devices, including
automated insulin dosing software, to receive, execute, and confirm
commands from these devices. The pump is indicated for use in
individuals six years of age and greater. The pump is intended for
single patient, home use and requires a prescription. The pump is
indicated for use with NovoLog or Humalog U-100 insulin. The t:slim
X2 pump must be removed before MRI, CT, or diathermy treatment.
Visit tandemdiabetes.com/safetyinfo for additional important safety
information.
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 107,000
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 and
@AbbottGlobal.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care,
Inc. (www.tandemdiabetes.com) is a medical device company dedicated
to improving the lives of people with diabetes through relentless
innovation and revolutionary customer experience. The company takes
an innovative, user-centric approach to the design, development,
and commercialization of products for people with diabetes who use
insulin. Tandem's flagship product, the t:slim X2 insulin pump, is
capable of remote software updates using a personal computer and
features integrated continuous glucose monitoring. Tandem is based
in San Diego, Calif.
Connect with Tandem Diabetes Care at www.tandemdiabetes.com, on
Twitter @tandemdiabetes, on Facebook at
www.facebook.com/TandemDiabetes, and on LinkedIn at
www.linkedin.com/company/TandemDiabetes.
Tandem Diabetes Care is a registered trademark and t:slim X2 is
a trademark of Tandem Diabetes Care, Inc. The Bluetooth word mark
and logos are registered trademarks owned by Bluetooth SIG, Inc.
and any use of such marks by Tandem Diabetes Care, Inc. is under
license.
Forward Looking Statement – Tandem Diabetes Care
This
press release contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended,
that concern matters that involve risks and uncertainties that
could cause actual results to differ materially from those
anticipated or projected in the forward-looking statements. These
forward-looking statements relate to development plans to integrate
Tandem insulin delivery systems with Abbott glucose-sensing
technology, create cohesive ecosystems and commercialize the
products for use in automated insulin delivery systems, as well as
Tandem's ability to offer remote software updates. These statements
are subject to numerous risks and uncertainties, including the
risks that technical challenges, clinical or regulatory hurdles or
other factors may prevent or delay integration/interoperability and
that the agreement between the companies could be terminated. These
and other risks and uncertainties are identified in Tandem's most
recent Annual Report on Form 10-K and Quarterly Reports on Form
10-Q, respectively, and other documents filed by Tandem with the
Securities and Exchange Commission. Readers are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date of this release. Tandem undertakes no
obligation to update or review any forward-looking statement in
this press release because of new information, future events or
other factors.
1 Data on file, Abbott Diabetes Care. Data based
on the number of users worldwide for the FreeStyle Libre system
compared to the number of users for other leading personal use,
sensor-based glucose monitoring systems.
2 The FreeStyle Libre 2 system is currently not
indicated for use with automatic insulin delivery systems. Future
uses for the FreeStyle Libre 2 System are under development and are
subject to FDA clearance.
3 Notifications will only be received when alarms
are turned on and the sensor is within 20 feet of the reading
device.
4 Based on FDA iCGM special controls.
5 Data on file, Abbott Diabetes Care. Data based on
the number of users worldwide for the FreeStyle Libre system
compared to the number of users for other leading personal-use,
sensor-based glucose monitoring systems.
6 Based on a comparison of list prices of the
FreeStyle Libre 14 day system versus competitors' CGM systems.
FreeStyle Libre 2 system will be list priced the same rate as
FreeStyle Libre 14 day system. The actual cost to patients may or
may not be lower than other CGM systems, depending on the amount
covered by insurance, if any.
7 U.S. Food and Drug Administration. FDA
authorizes first interoperable insulin pump intended to allow
patients to customize treatment through their individual diabetes
management devices; 2019. Available at
https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-insulin-pump-intended-allow-patients-customize-treatment-through.
Accessed October 14, 2019.
8 Tested to a depth of 3 feet for 30 minutes.
9 Additional feature updates are subject to future
FDA approvals. A prescription and additional training may be
required to access certain future software updates.
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SOURCE Abbott