Tandem Diabetes Care Begins Enrollment in Pivotal Trial for First Touchscreen Insulin Pump with Predictive Low Glucose Suspen...
August 15 2017 - 8:30AM
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 Updater.”
“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.
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 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 at
www.tandemdiabetes.com/updater. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170815005421/en/
Tandem Diabetes Care, Inc.Media Contact:Steve
Sabicer714-907-6264ssabicer@thesabicergroup.comorInvestor
Contact:Susan Morrison858-366-6900
x7005smorrison@tandemdiabetes.com
Tandem Diabetes Care (NASDAQ:TNDM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Tandem Diabetes Care (NASDAQ:TNDM)
Historical Stock Chart
From Apr 2023 to Apr 2024