Tandem Diabetes Care Announces FDA Approval and Launch of t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM Integration
‒ Software Update Available for Current t:slim X2 Pump Users Via Personal Computer ‒
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
"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,"
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
For additional t:slim X2 Pump product and safety information, or to
begin the order process, visit
or call 877-801-6901, Monday - Friday
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 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
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
|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.
Additional feature updates are not currently available for the
t:slim X2 Pump with Dexcom G5 Mobile CGM integration and are subject
38% smaller than MiniMed 630G and 670G and at least 28% smaller than
MiniMed 530G, Animas Vibe and Omnipod System. Data on file,
|Tested to 3 feet for 30 minutes (IPX7 rating).
Reznik Y, Cohen O, Aronson R, et al.
|Hoogma RPLM, Hammond PJ, Gomis R, et al. Diabet Med. 2005;23:141-147.
|Bode BW, Sabbah HT, Gross TM. Diabet Metab Res Rev. 2002;18(suppl 1):S14-S20.
|Foster N, Miller K, Tamborlane W, Bergenstal R, Beck R, & T1D Exchange Clinical Network (2016). Diabetes Care 2016 Jun; 39(6): e81-e82.
Polonsky B, Hessler D, Ruedy K,
Source: Tandem Diabetes Care®, Inc.
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