Tandem Diabetes Care Announces Commercial Launch of t:slim X2 Insulin Pump with Basal-IQ Technology in the United States
August 17 2018 - 9:00AM
Business Wire
Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device
company and manufacturer of the only touchscreen insulin pumps with
continuous glucose monitoring (CGM) integration, today announced
its launch of the t:slim X2™ Insulin Pump with Basal-IQ™
Technology, a predictive low glucose suspend (PLGS) feature
designed to help reduce the frequency and duration of low glucose
events (hypoglycemia). It is integrated with the Dexcom G6® CGM
System, which requires no fingersticks for calibration or diabetes
treatment decisions.1,2 The Company has begun sending emails with
update instructions to all in-warranty t:slim X2 users in the
United States, who have the option to add the new feature free of
charge via remote software update.3 t:slim X2 Pumps pre-loaded with
Basal-IQ Technology are expected to begin shipping to new customers
by the end of August.
Tandem’s Basal-IQ algorithm is designed to look 30 minutes into
the future to predict where glucose levels are heading. The device
suspends insulin delivery when low glucose is predicted, then
automatically resumes insulin delivery once glucose levels begin to
rise. In the pivotal clinical study, use of the t:slim X2 Pump with
Basal-IQ Technology demonstrated a 31 percent relative reduction in
time spent below 70 mg/dL, with no rebound hyperglycemia compared
to a CGM-enabled insulin pump without the feature. The system
received high usability scores in the study, with 93 percent of
participants indicating that the system was easy to use, and 97
percent indicating that they felt confident using the system.4
“This launch marks the achievement of our goal to offer people
with diabetes a simple-to-use automated insulin delivery feature
that can reduce time spent low without adding significant burden to
the pump therapy experience,” said Kim Blickenstaff, president and
CEO of Tandem Diabetes Care. “Our ability to provide remote
software updates, allowing in-warranty t:slim X2 Pump users the
ability to add Basal-IQ Technology to their current pumps using a
personal computer, is unparalleled in the industry and further
differentiates the t:slim X2 Insulin Pump from other devices on the
market.”
Update Instructions for In-warranty t:slim X2 Pump
Users
No action is required at this time. Individual emails are being
sent to all in-warranty t:slim X2 Pump users in the United States
with information on how to start the update process. Emails are
being sent out in batches, with all users anticipated to have
received the information by the end of August. The Basal-IQ feature
update will require a new prescription and completion of a
45-minute online training module, all of which will be coordinated
through a simple-to-use online portal. Internet and computer access
are required for pump updates. Basal-IQ Technology is only
compatible with the Dexcom G6® CGM System. t:slim X2 Pump users who
have Dexcom G5® Mobile CGM supplies they plan to use may want to
postpone this update until they are ready to switch to the new
Dexcom G6 CGM System. More information about the update process and
system requirements is available at
www.tandemdiabetes.com/X2update.
Free Basal-IQ Technology Demo App
Tandem’s free t:simulator™ App lets users experience the
touchscreen interface of the t:slim X2 Insulin Pump with Basal-IQ
Technology directly on a mobile device. For more information and to
download the app, visit
http://www.tandemdiabetes.com/tsimulator.
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 with Basal-IQ™ technology. The t:slim
X2 Pump is capable of remote feature updates using a personal
computer and is the only automated insulin delivery device approved
for children as young as 6 years old. Tandem is based in San Diego,
California.
For additional product and safety
information, or to begin the order process, visit
www.tandemdiabetes.com/tslimX2 or call 877-801-6901,
Monday – Friday between 6am and 5pm Pacific Time.
Important Safety Information
RX ONLY. The t:slim X2 Insulin Pump with Basal-IQ Technology
(the System) consists of the t:slim X2 Insulin Pump, which contains
Basal-IQ Technology, and a compatible CGM. CGM sold separately. The
t:slim X2 Insulin Pump is intended for the subcutaneous delivery of
insulin, at set and variable rates, for the management of diabetes
mellitus in persons requiring insulin. The t:slim X2 Insulin Pump
can be used solely for continuous insulin delivery and as part of
the System. When the System is used with a compatible iCGM, the
Basal-IQ Technology can be used to suspend insulin delivery based
on CGM sensor readings. Interpretation of the System results should
be based on the trends and patterns seen with several sequential
readings over time. CGM also aids in the detection of episodes of
hyperglycemia and hypoglycemia, facilitating both acute and
long-term therapy adjustments. Compatible iCGM systems are intended
for single patient use and require a prescription. The System is
indicated for use in individuals 6 years of age and greater. The
System is intended for single patient use and requires a
prescription. The System is indicated for use with NovoLog or
Humalog U-100 insulin. The System is not approved for use in
pregnant women, persons on dialysis, or critically ill
patients.
Tandem Diabetes Care is a registered trademark, and t:slim X2,
Basal-IQ and t:simulator are trademarks of Tandem Diabetes Care,
Inc. Dexcom and Dexcom G6 are registered trademarks of Dexcom, 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 relate to, among other things, the
anticipated timing for the commercial launch of the t:slim X2 with
Basal-IQ Technology and our ability to offer the Basal-IQ software
update for current t:slim X2 Pump users. These statements are
subject to numerous risks and uncertainties, including our ability
to commence commercial scale manufacturing of the t:slim X2 with
Basal-IQ Technology, our ability to launch a new system to
facilitate online training and prescription handling for existing
t:slim X2 customers upgrading their existing devices, and the risk
that we may encounter other challenges that may delay the
commercial launch of t:slim X2 with Basal-IQ Technology, as well as
other risks identified in our most recent Annual Report on Form
10-K and Quarterly Reports on Form 10-Q, and other documents that
we file 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 If glucose alerts and CGM readings do not match symptoms or
expectations or if taking over the recommended maximum dosage
amount of 1000 mg of acetaminophen every 6 hours, use a blood
glucose meter to make diabetes treatment decisions.2 Dexcom G6 CGM
sold separately. The Dexcom G6 CGM transmitter can only be paired
with one medical device (either a Dexcom receiver or t:slim X2
Pump) and one consumer device (phone or tablet) at the same time.3
A new prescription and additional training are required for this
software update.4 Forlenza GP, Li Z, Buckingham BA, Pinsker JE, et
al. Predictive low glucose suspend reduces hypoglycemia in adults,
adolescents, and children with type 1 diabetes in an at-home
randomized crossover study: Results of the PROLOG trial [published
online August 8, 2018]. Diabetes Care. doi:10.2337/dc18-0771.
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version on businesswire.com: https://www.businesswire.com/news/home/20180817005050/en/
Tandem Diabetes Care Contact Information:Media: Steve
Sabicer, 714-907-6264ssabicer@thesabicergroup.comorInvestors: Susan
Morrison, 858-366-6900 x7005IR@tandemdiabetes.com
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