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 announced enrollment of the first patients in an
at-home pivotal trial for its t:slim X2™ Insulin Pump using Tandem's
predictive low glucose suspend (PLGS) technology. The insulin pump
system, which uses an integrated Dexcom G5® Mobile Continuous Glucose
Monitor (CGM), is designed to suspend insulin delivery when low blood
glucose is predicted and subsequently resume insulin delivery when
glucose levels begin to rise.
The PROLOG (PLGS for Reduction
Of LOw Glucose)
study is a multi-center, randomized crossover study comparing two 3-week
periods of at-home insulin pump use, one period using the t:slim X2 Pump
with PLGS, and another period using a standard CGM-integrated t:slim X2
Pump without automated insulin suspension. The clinical trial will
include 90 participants with type 1 diabetes ages 6 and above at five
research centers across the United States and is being coordinated by
the Jaeb Center for Health Research in Tampa, Florida. The primary
endpoint of the study is to demonstrate a reduction in the percentage of
CGM values below 70 mg/dL when using Tandem's PLGS algorithm.
"The start of this pivotal trial is another important step forward in
our automated insulin delivery programs, and comes on the heels of very
encouraging feasibility study data," said Kim Blickenstaff, president
and CEO of Tandem Diabetes Care. "We remain on track to submit our
t:slim X2 Pump with predictive low glucose suspend to the FDA in early
2018. Subject to FDA approval, we are preparing to launch in summer of
2018, and plan to make this new feature accessible for existing t:slim
X2 customers via a remote software update using our Tandem Device
"Mild to moderate hypoglycemia occurs frequently during the day for
people with type 1 diabetes, but of more concern is the severe
hypoglycemia which can occur at night causing seizures or even death.
This is a real concern to all people living with type 1 diabetes, and
especially parents of children with type 1," said Dr. Bruce Buckingham,
Professor of Pediatric Endocrinology at The Lucille Salter Packard
Children's Hospital, Stanford University, and principal investigator of
the PROLOG trial. "This new PLGS algorithm will allow for the automatic
suspension of insulin delivery when glucose is predicted to be low. This
is beneficial throughout the day but can be lifesaving at night when a
person is otherwise unable to react."
Full trial details and site contact information can be found at https://clinicaltrials.gov/ct2/show/NCT03195140.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com)
is a medical device company with an innovative, user-centric and
integrated approach to the design, development and commercialization of
products for people with diabetes who use insulin. The Company
manufactures and sells the t:slim X2™ Insulin Pump, the slimmest and
smallest durable insulin pump currently on the market; the t:flex®
Insulin Pump, the first pump designed for people with greater insulin
requirements; and the t:slim G4™ Insulin Pump, the first continuous
glucose monitoring-enabled pump with touchscreen simplicity. Tandem is
based in San Diego, California.
About the Tandem Device Updater
The Tandem Device Updater is a Mac® and PC-compatible application for
the remote update of Tandem insulin pump software. Remote software
updates have the potential to allow all t:slim X2 Pump users access to
future features as they are approved by the FDA. Tandem is the only
company that allows its customers to remotely update features on their
insulin pump from home using a personal computer without waiting for
their insurance to cover a new device.1 Subject to FDA
approval, Tandem plans to make the new PLGS feature available to
existing t:slim X2 customers via a remote software update using the
Tandem Device Updater.2
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.
t:slim, t:flex, Micro-Delivery and Tandem Diabetes Care are registered
trademarks, and t:slim X2, t:slim G4 and t:simulator are trademarks of
Tandem Diabetes Care, Inc.
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 successfully
complete the pivotal trial for the t:slim X2 Pump with PLGS when
anticipated, submit future regulatory applications, secure regulatory
approvals for the t:slim X2 Pump with PLGS, and offer future software
improvements and enhancements to Tandem pumps using the Tandem Device
Updater. The Company's actual results may differ materially from those
indicated in these forward-looking statements due to numerous risks and
uncertainties. For instance, successful completion of the pivotal trial
is dependent on the rate of enrollment in the study and the cooperation
of multiple clinical research sites that are largely outside of the
Company's control. In addition, the pivotal trial results may not be
adequate to support a future regulatory application when anticipated and
it is possible that the t:slim X2 Pump with PLGS may not be approved by
the FDA in a timely manner or at all. Further, the future
commercialization of the Company's products may be negatively impacted
by many other factors, including: lack of market acceptance by
physicians, payors and people with diabetes; the potential that newer
products that compete with the Company's products, or other
technological breakthroughs for the monitoring, treatment or prevention
of diabetes, may render the Company's products obsolete or less
desirable; and the potential that the Tandem Device Updater may fail to
perform according to its specifications or may not provide people with
diabetes with anticipated benefits. 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 Available software updates for Tandem products can be found
Additional software updates and new features are subject to future FDA
approvals. Charges may apply.
2 Subject to FDA submission and approval. Charges may apply.
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Tandem Diabetes Care, Inc.
Source: Tandem Diabetes Care, Inc.
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