SAN DIEGO--(BUSINESS WIRE)--
Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and
manufacturer of the only touchscreen insulin pumps available in the
United States, today presented results from a Human Factors study
conducted to validate the safety of the user interface of a predictive
low glucose suspend (PLGS) feature as part of the t:slim X2™ Insulin
Pump. The study included users ages 6 and up (N=53), with and without
experience using an insulin pump or continuous glucose monitoring (CGM).
The study demonstrated a 99 percent success rate among study
participants who performed a series of critical tasks using the PLGS
system after initial training. Out of 530 tasks performed, only seven
task failures were observed, none of which were related to safety. These
data were presented today during a poster session at the 2017 Diabetes
Technology Meeting (DTM) in Bethesda, Maryland.
"This study demonstrates that the t:slim X2 System with PLGS requires
minimal training and is easy to use, even for people without pump or CGM
experience," said Betsy Dokken, PhD, Director of Clinical Affairs at
Tandem Diabetes Care. "We believe that the high success rate and minimal
errors observed in this study highlight the importance of human factors
research in insulin pump development, particularly with the introduction
of automated insulin delivery algorithms."
The study was conducted at four independent research centers in the
United States. Training consisted of live one-hour sessions on the
t:slim X2 Pump and the Dexcom G5 Mobile CGM System with a break in
between. These were waived for current Tandem and Dexcom users, or were
shortened for those with previous pump and/or CGM experience.
Participants then took a 45-minute computer-based training module on the
PLGS feature. Following a one-hour break, they were asked to complete 10
critical tasks on the device in a simulated environment in order to
uncover and identify errors and difficulties. Parents were permitted to
help children. Interactions were observed and scored by a researcher
seated in a separate observation room. Successful performance required
completion of the task without any observed errors or assistance from
the study moderator. Pass/fail scoring was completed according to
pre-set criteria.
Data from a feasibility study on Tandem's PLGS system was presented this
summer at the 77th Scientific Sessions of the American Diabetes
Association. A pivotal trial is currently underway and anticipated to be
complete by the end of 2017. The Company is preparing to launch its
t:slim X2 Pump with PLGS in the summer of 2018, subject to future U.S.
Food and Drug Administration review and approval.
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.
Forward Looking Statement
This press release includes forward-looking statements relating to the
Company's t:slim X2® Insulin Pump featuring a predictive low glucose
suspend, including the conclusions from research studies on the ease of
use of the pump, the effectiveness of training and the anticipated
completion of the Company's pivotal trial for the PLGS system. Such
statements are based on management's current expectations, but actual
results may differ materially due to various risks and uncertainties,
including risks that (i) current and past results of research studies
may not be indicative of results of future research studies or of actual
user experience, (ii) the Company may experience unanticipated delays in
the completion of the pivotal trial for the PLGS system or the results
of the pivotal trial may not be adequate to support a future regulatory
submission and approval of the t:slim X2 with PLGS system, and (iii) the
launch of the t:slim X2 with PLGS may be delayed due to the uncertainty
generally associated with the regulatory review process. Forward looking
statements are also subject to other risks and uncertainties, including
those identified in the Company's most recent Annual Report on Form 10-K
and Quarterly Report on Form 10-Q, as well as 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 any forward-looking statement in this
press release.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2,
#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 and t:flex are registered trademarks, and t:slim X2
and t:simulator are trademarks of Tandem Diabetes Care, Inc. Dexcom and
Dexcom G5 are registered trademarks of Dexcom, Inc. All other trademarks
are the property of their respective owners.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171102006651/en/
Tandem Diabetes Care, Inc.
Media Contact:
Steve
Sabicer, 714-907-6264
ssabicer@thesabicergroup.com
or
Investor
Contact:
Susan Morrison, 858-366-6900 x7005
smorrison@tandemdiabetes.com
Source: Tandem Diabetes Care, Inc.
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