Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, today announced
publication of real-world data from more than 8,000 users of the
t:slim X2™ insulin pump with Basal-IQ® predictive low-glucose
suspend technology in the medical journal Diabetes Technology and
Therapeutics. The results demonstrate sustained reductions in
hypoglycemia across all groups using Basal-IQ technology,
regardless of prior therapy. A specific sub-analysis of t:slim X2
pump users who remotely updated their pump software to Basal-IQ
technology revealed a 45 percent relative risk reduction in
hypoglycemia and a 71 percent relative risk reduction of
hypoglycemic events. The reductions in hypoglycemic outcomes with
real-world use exceeded reductions observed in the controlled
pivotal study for Basal-IQ technology.
“This data supports the overwhelmingly positive feedback we hear
from our customers using Basal-IQ technology and the clinical
improvement people often report experiencing after initiating its
use,” said John Sheridan, president and CEO of Tandem Diabetes
Care. “We continue to hear that our t:slim X2 insulin pump with
Basal-IQ technology is extremely simple to learn and use, which is
a core tenet across all of our products, and we believe this leads
to greater customer satisfaction and improved clinical
outcomes.”
Summary of Hypoglycemia Data Published in Diabetes Technology
and Therapeutics1
A retrospective analysis was conducted using deidentified data
from the t:connect® diabetes management application. The analysis
included data from patients ages 6 and up who had used Basal-IQ
technology for at least 21 days between August 31, 2018 and March
14, 2019 (N = 8,123). Two sub-analyses were also conducted. The
first looked at people who used a t:slim X2 insulin pump with
continuous glucose monitoring (CGM) integration for 21 days prior
to starting Basal-IQ technology (n = 1,371). The second included
people who had at least nine weeks of Basal-IQ technology use
regardless of prior therapy or insulin pump experience
(n = 3,563).
Use of the t:slim X2 insulin pump with Basal-IQ technology led
to an immediate and sustained reduction in hypoglycemic events. In
the sub-analysis of people who used a CGM-enabled t:slim X2 pump
prior to initiation of Basal-IQ technology, introduction of the
feature reduced the mean time spent below 70 mg/dL from 3.0 percent
to 1.76 percent, which represents a 45 percent relative risk
reduction of hypoglycemia. The sub-analysis of those with nine
weeks of Basal-IQ technology use showed that mean time spent below
70 mg/dL decreased sharply on the first day of use and remained low
(1.74 percent) over time. Other outcome measures included time in
range, mean glucose, hyperglycemia, and total daily dose.
Reference:
Muller L, Habif S, Leas S, Aronoff-Spencer E. Reducing
Hypoglycemia in the Real World: A Retrospective Analysis of
Predictive Low-Glucose Suspend Technology in an Ambulatory
Insulin-Dependent Cohort. Diab Technol Ther. 2019;21(9):474-484.
DOI: 10.1089/dia.2019.0190
Link to full article (open access):
https://www.liebertpub.com/doi/10.1089/dia.2019.0190
About the t:slim X2 Insulin Pump with Basal-IQ
Technology
The simple-to-use t:slim X2 insulin pump with Basal-IQ
predictive low glucose suspend technology uses glucose values from
an integrated Dexcom G6 continuous glucose monitor to predict and
help prevent lows with zero fingersticks*. The t:slim X2 pump
includes advanced features like a large color touchscreen,
rechargeable battery, Bluetooth® wireless technology, USB
connectivity and watertight construction (IPX7)2. It is capable of
remote software updates using a personal computer, offering the
potential for in-warranty users to access new features as they meet
necessary regulatory requirements3. The t:slim X2 pump is up to 38
percent smaller than other insulin pumps and holds up to 300 units
of insulin.4
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.
Free t:slim X2 Pump Software Updates Through End of
2020
Tandem is the only company that offers remote software updates
for its insulin pumps as new features are approved by the U.S. Food
and Drug Administration (FDA). All software updates approved by the
FDA through the end of 2020 will be offered for no cost through the
Tandem Device Updater for in-warranty customers who purchase a pump
prior to December 31, 2020, including current customers5.
For additional product and safety
information, or to begin the order process, visit
www.tandemdiabetes.com/tslimX2
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. Tandem 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, which features
integrated continuous glucose monitoring and remote software
updates. Tandem is based in San Diego, California.
Tandem Diabetes Care, Basal-IQ and t:connect are registered
trademarks, and t:slim X2 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
ability of the t:slim X2 pump to provide remote feature updates,
the timing and outcome of regulatory approvals for new product
features and updates, and the ability of our products to improve
customer satisfaction and clinical outcomes. These statements are
subject to numerous risks and uncertainties, including the risks
that technical problems may prevent or delay remote software
updates, regulatory agencies may fail to approve new product
features or updates on our expected timeframe or at all, and the
level of customer satisfaction from the use of our products and
features may be different from what we expect, as well as other
risks identified in Tandem’s most recent Annual Report on Form 10-K
and Quarterly Reports on Form 10-Q, respectively, and other
documents 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.
* If glucose alerts and CGM readings do not match symptoms or
expectations, use a blood glucose meter to make diabetes treatment
decisions. Dexcom G6 CGM sold separately.
1 DTT reference
2 Tested to a depth of 3 feet for 30 minutes
3 Additional feature updates are not currently available for the
t:slim X2 pump with Basal-IQ technology and are subject to future
FDA approvals. A prescription and additional training may be
required to access certain future software updates.
4 38 percent smaller than MiniMed 630G and 670G and at least 28
percent smaller than MiniMed 530G, Animas Vibe and Omnipod System.
Data on file, Tandem Diabetes Care.
5 Additional feature updates are not currently available for the
t:slim X2 pump with Basal-IQ technology and are subject to future
FDA approvals. A prescription and additional training may be
required to access certain future software updates. Offer only
available to customers who reside in the United States, who are in
warranty at the time they update their pump and who purchased a
t:slim X2 insulin pump on or before December 31, 2020. Tandem may
discontinue select software and features over time at its
discretion. This is a limited time offer and Tandem reserves the
right to discontinue this program at its discretion.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190918005293/en/
Media Contact: Steve Sabicer, (714) 907-6264,
ssabicer@thesabicergroup.com
Investor Contact: Susan Morrison, (858) 366-6900 x7005,
smorrison@tandemdiabetes.com
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