‒ Software Update Available for Current t:slim
X2 Pump Users Via Personal Computer ‒
Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device
company and manufacturer of the only touchscreen insulin pumps
available in the United States, today announced U.S. Food and Drug
Administration (FDA) approval and commercial launch of the t:slim
X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose
monitoring (CGM) integration, the first sensor-augmented insulin
pump approved to let users make treatment decisions without
pricking their finger1. The software featured on this pump will
also be available to current t:slim X2 Pump users at no cost via
remote software update, allowing them to add CGM integration to
their existing pumps from home using a personal computer.
Individual emails are being sent directly to t:slim X2 Pump
customers with instructions on how to perform the update. The
t:slim X2 Pump with Dexcom G5 Mobile CGM integration is approved
for ages 6 and older.
This approval marks the Company’s fifth new insulin pump launch
in only 5 years and the second featuring Dexcom technology. It is
the only available pump that conveniently displays a user’s insulin
delivery activity and Dexcom G5 Mobile CGM data together on a
single device. The t:slim X2 Pump is also the only insulin pump
capable of remote software updates2, allowing existing users to add
features like CGM integration from home. It is up to 38% smaller
than other pumps3, but includes advanced features like a large
color touchscreen, Bluetooth® radio, rechargeable battery, USB
connectivity, 300-unit insulin capacity and watertight construction
(IPX7)4.
“We are setting a new standard in our industry by simultaneously
offering our existing and future customers the benefits of
best-in-class CGM integration on our simple-to-use touchscreen
insulin pump,” said Kim Blickenstaff, president and CEO of Tandem
Diabetes Care. “The t:slim X2 Pump is designed to accelerate the
pace in which we can bring new innovations to people with diabetes,
which is of particular importance as we develop software updates to
add automated insulin delivery algorithms to our platform.”
“Dexcom has been moving its technology forward at a rapid pace,
and Tandem’s ability to roll out remote software updates like this
opens up exciting possibilities for faster integrations of our
future products,” said Steve Pacelli, Executive Vice President of
Strategy and Corporate Development at Dexcom. “We are excited to
have our latest CGM technology integrated with their t:slim X2
Insulin Pump, and to see it offered not only to new customers but
also to existing t:slim X2 Pump users.”
The t:slim X2 Pump can operate as a stand-alone insulin pump
without CGM, or be paired with the Dexcom G5 Mobile CGM to track
glucose continuously and display that information directly on the
pump’s home screen. Dexcom G5 Mobile is the only CGM system FDA
approved to let users make treatment decisions without pricking
their finger. Dexcom is also consistently rated the #1 CGM brand in
independent patient surveys5. In addition to integration with the
t:slim X2 Pump, dynamic glucose data from the Dexcom G5 Mobile CGM
can be easily accessed and shared using a compatible mobile
device.
For additional t:slim X2 Pump product and
safety information, or to begin the order process,
visitwww.tandemdiabetes.com/tslimX2or call
877-801-6901, Monday – Friday between 6am and 5pm Pacific
Time
Download Tandem’s free t:simulator™ App to experience the
touchscreen interface of the t:slim X2 Pump with Dexcom G5 Mobile
CGM integration directly on your mobile device. For more
information and to download the app, visit
http://www.tandemdiabetes.com/tsimulator.
Information for Current t:slim X2 Pump Users
All eligible t:slim X2 Pump users have the option to add Dexcom
G5 Mobile CGM integration via a software update using a personal
computer. Individual emails are being sent directly to t:slim X2
Pump customers with instructions on how to perform the update. The
software update is Mac® and PC compatible. For more information on
system requirements, visit www.tandemdiabetes.com/updater.
Remote Software Updates for Insulin Pumps
Tandem is the only company with a tool for providing remote
software updates for its insulin pumps using a personal computer.
The power of the t:slim X2 Pump’s touchscreen allows for buttons to
be moved and data like the interactive CGM screen to be added via
software updates without getting a new device. With innovations in
diabetes technology consistently moving faster than the typical
insurance pump replacement cycle, remote software updates make it
easier to make a purchasing decision today without worrying that
the device will soon be outdated. Future Tandem products are being
developed with software updates in mind, with the goal of
delivering new technologies to both new and current customers at
the same time.2
The Benefits of Insulin Pump Therapy with CGM
Published studies have shown that insulin pump therapy, when
paired with proper training and support, can result in better blood
sugar control and lower total daily insulin use compared to
multiple daily injections.6,7,8 CGM has demonstrated improved blood
sugar control, increased confidence related to the risk of low
blood sugar, and decreased diabetes stress.9,10 Combining insulin
pump therapy and CGM has demonstrated the best overall glucose
control compared to multiple daily injections or pump therapy
alone, in addition to the quality of life improvements associated
with each individual therapy.9
Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects
more than 29 million people in the United States, or nearly 1 in 10
Americans. Tandem estimates that more than 3 million people in the
United States require daily administration of insulin and are
candidates for pump therapy. More than 425,000 Americans with type
1 diabetes use an insulin pump, or approximately 27% of the type 1
diabetes population. In addition, approximately 125,000 Americans
with type 2 diabetes use an insulin pump, a small fraction of the
type 2 diabetes population.
The t:slim X2 Pump with Dexcom G5 Mobile CGM integration will
replace the Company’s previous-generation t:slim G4™ Pump. The
Company will continue to service all current t:slim G4 Pumps for
the duration of their warranty. An upgrade program is available
through September 30, 2017, for t:slim and t:slim G4 Pump users
interested in accessing the t:slim X2 Pump. For more information,
visit www.tandemdiabetes.com/upgrade.
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 manufactures and sells
the t:slim X2™ Insulin Pump, the only pump capable of remote
feature updates using a personal computer, and the t:flex® Insulin
Pump, the first pump designed for people with greater insulin
requirements. Tandem is based in San Diego, California.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use
#tslimX2, #tslimG4, #tflex, #tconnect, and $TNDM.Follow Tandem
Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.Follow
Tandem Diabetes Care on LinkedIn at
https://www.linkedin.com/company/tandemdiabetes.
Tandem Diabetes Care is a registered trademarks, and t:slim X2
and t:slim G4 are trademarks of Tandem Diabetes Care, Inc. Dexcom
and Dexcom G5 are registered trademarks of Dexcom, Inc. Bluetooth®
is a registered trademark of Bluetooth SIG, Inc. All other
trademarks are the property of their respective owners.
Forward-Looking Statement
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 include
statements regarding the Company’s ability to develop software
updates that add automated insulin delivery algorithms to the
t:slim X2 and the potential for faster integration with Dexcom
products in the future. The Company's actual results may differ
materially from those indicated in these forward-looking statements
due to numerous risks and uncertainties, including the Company’s
ability to complete the development of automated insulin delivery
algorithms for the t:slim X2, the Company’s ability to successfully
complete clinical trials for new products when anticipated (or at
all), the potential that the results of any such clinical trials
may not be sufficient to support regulatory approvals for new
products as anticipated and the Company’s ability to obtain
regulatory approvals for future products and product features
generally. Other risks and uncertainties are identified in the
Company’s most recent Annual Report on Form 10-K and Quarterly
Report on Form 10-Q, and other documents that the Company files
with the Securities and Exchange Commission. Investors 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 CGM-based treatment requires fingersticks for
calibration; may result in hypoglycemia if calibration not
performed, when taking acetaminophen, or if symptoms/expectations
do not match CGM readings. 2 Additional feature updates are not
currently available for the t:slim X2 Pump with Dexcom G5 Mobile
CGM integration and are subject to future FDA approvals. Charges
may apply. 3 38% smaller than MiniMed 630G and 670G and at least
28% smaller than MiniMed 530G, Animas Vibe and Omnipod System. Data
on file, Tandem Diabetes Care. 4 Tested to 3 feet for 30 minutes
(IPX7 rating). 5 dQ&A USA Diabetes Connections Surveys,
2009-2016. 6 Reznik Y, Cohen O, Aronson R, et al. Lancet.
2014;384(9950):1265-1272. 7 Hoogma RPLM, Hammond PJ, Gomis R, et
al. Diabet Med. 2005;23:141-147. 8 Bode BW, Sabbah HT, Gross TM.
Diabet Metab Res Rev. 2002;18(suppl 1):S14-S20. 9 Foster N, Miller
K, Tamborlane W, Bergenstal R, Beck R, & T1D Exchange Clinical
Network (2016). Diabetes Care 2016 Jun; 39(6): e81-e82. 10 Polonsky
B, Hessler D, Ruedy K, Beck R. & DIAMOND Study Group. Diabetes
Care. 2017. doi:10.2337/dc17-0133. [Epub ahead of print]
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version on businesswire.com: http://www.businesswire.com/news/home/20170828005281/en/
For Tandem Diabetes Care, Inc.Media Contact:Steve
Sabicer, 714-907-6264ssabicer@thesabicergroup.comorInvestor
Contact:Susan Morrison, 858-366-6900
x7005smorrison@tandemdiabetes.com
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