Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device
company and manufacturer of the only touchscreen insulin pumps
available in the United States, Dexcom, Inc. (NASDAQ: DXCM), a
leader in continuous glucose monitoring (CGM) for people with
diabetes, and TypeZero Technologies, LLC, a digital health and
personalized medicine company, today announced that they are
working together on the integration of their technologies into the
NIH-funded International Diabetes Closed Loop (IDCL) Trial starting
later this year.
This Smart News Release features multimedia.
View the full release here:
http://www.businesswire.com/news/home/20161110005485/en/
A Tandem insulin pump and Dexcom G5 sensor will be included as
part of a blood glucose control system that combines these devices
with a smartphone running TypeZero’s inControl closed loop
algorithm. The system predicts high and low blood sugar levels and
adjusts insulin delivery accordingly throughout the day, while
still allowing the user to manually bolus for meals. In addition to
basal insulin adjustments, TypeZero’s inControl system also
automates correction boluses. Tandem and Dexcom anticipate adding a
Dexcom G6 sensor-integrated t:slim X2 Pump that incorporates
inControl’s algorithms directly into the pump’s touchscreen
interface to the IDCL Trial in 2017. The companies anticipate that
the integrated design, together with data from the IDCL Trial, will
be the basis for a future regulatory submission by Tandem.
“The IDCL Trial is designed as a pivotal trial of a closed-loop
control-to-range system, and includes seven institutions in the
U.S. and three in Europe led by the University of Virginia,” said
Boris Kovatchev, PhD, Director of the Center for Diabetes
Technology at the University of Virginia and principal investigator
of the IDCL Trial. “The integration of technology provided by
Tandem, Dexcom, and TypeZero in this trial represents a new level
of sophistication in artificial pancreas research and
development.”
“A world-class automated insulin delivery system needs to be
simple to use, rely on the most accurate CGM data available, and
use a proven and trusted algorithm,” said Kim Blickenstaff,
president and CEO of Tandem Diabetes Care. “We believe the
combination of Tandem, Dexcom, and TypeZero technologies will
deliver all three, and we are honored to be working together with
them for this trial.”
"Our efforts with Tandem began with the display of CGM data on
their t:slim G4 Pump and we are pleased to take this next step in
the integration of our future products to support automated insulin
delivery," said Steve Pacelli, EVP, Strategy & Corporate
Development at Dexcom.
“The addition of Tandem’s innovative touchscreen pumps to the
IDCL Trial is tremendous, and a great first step in their
integration of our inControl algorithm into a future software
update for the t:slim X2 Pump,” said Chad Rogers, Chief Executive
Officer at TypeZero Technologies. “We look forward to bringing
these solutions to patients in the upcoming IDCL trial and
ultimately delivering a best-in-class automated insulin delivery
solution to patients across the globe.”
The IDCL Trial is expected to enroll 240 adults with type 1
diabetes and is projected to start in late 2016. TypeZero’s
technology includes a series of algorithms developed from initial
research conducted at the University of Virginia. To date, this
technology has been used in more than 28 clinical studies including
more than 475 participants, with data referenced in a number of
journal articles.1
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 touch-screen
simplicity. Tandem is based in San Diego, California.
About Dexcom, Inc.
Dexcom, Inc., headquartered in San Diego, CA, is dedicated to
helping people better manage their diabetes by developing and
marketing continuous glucose monitoring (CGM) products and tools
for adult and pediatric patients. With exceptional performance,
patient comfort and lifestyle flexibility at the heart of its
technology, users have consistently ranked Dexcom highest in
customer satisfaction and loyalty. For more information on the
Dexcom CGM, visit www.dexcom.com.
About TypeZero Technologies, LLC
The world leader in clinically tested artificial pancreas
solutions, TypeZero Technologies is a digital health and
personalized medicine startup dedicated to revolutionizing the
treatment and management of diabetes. TypeZero is combining
next-generation data science techniques, proven metabolic models,
and modern engineering practices to develop customized analytics
tools and blood glucose control solutions to help people with
diabetes improve their health and lives. TypeZero’s current
products include a smartphone-based Artificial Pancreas system,
therapy optimization tools for health care providers, and advisory
applications for smart insulin pens. To learn more, visit
www.typezero.com.
t:slim, t:flex, and Tandem Diabetes Care are registered
trademarks, and t:slim X2 and t:slim G4 are trademarks of Tandem
Diabetes Care, Inc. Dexcom, Dexcom G5 and Dexcom G6 are registered
trademarks of Dexcom, 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 relate to, among other things, the
timing of anticipated enrollment and commencement of the IDCL
trial, the use of a Tandem insulin pump and Dexcom G5 sensor as
part of a system that combines these devices with a smartphone
running TypeZero’s inControl algorithm in the IDCL trial, the
current plan to develop and use a Dexcom G6 sensor-integrated
t:slim X2 Pump that incorporates the inControl algorithm directly
into the pump’s touchscreen interface as part of the IDCL trial in
the future and whether the integrated design will be the basis for
a future regulatory filing by Tandem. These statements are subject
to numerous risks and uncertainties, including the risk that the
IDCL trial will be completed as currently contemplated, Tandem’s
ability to complete the development of a Dexcom G6
sensor-integrated t:slim X2 that incorporates the inControl
algorithm directly into the pump’s touchscreen interface, Dexcom’s
ability to secure regulatory approval for the Dexcom G6 CGM and
Tandem’s ability to rely on the data from the IDCL trial to support
future regulatory filing, as well as other risks identified in
Tandem’s or Dexcom’s most recent Annual Reports on Form 10-K and
Quarterly Reports on Form 10-Q, respectively, and other documents
that they 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. The
companies undertake no obligation to update or review any
forward-looking statement in this press release because of new
information, future events or other factors.
1 Recent Publications Highlighting Research Using TypeZero AP
Technology: (a) Ly T, Buckingham B, DeSalvo et al. Day-and-Night
Closed-Loop Control Using the Unified Safety System in Adolescents
With Type 1 Diabetes at Camp. Diabetes Care 2016 Aug; 39(8):
e106-e107. (b) Anderson S, Raghinaru D, Pinsker J, et al.
Multinational Home Use of Closed-Loop Control Is Safe and
Effective. Diabetes Care. 2016 Jul;39(7):1143-50. (c) Boris P.
Kovatchev, Eric Renard, Claudio Cobelli, et
al. Safety of Outpatient Closed-Loop Control: First
Randomized Crossover Trials of a Wearable Artificial
Pancreas. Diabetes Care. 2014 Jul; 37(7): 1789–1796.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161110005485/en/
Tandem Diabetes Care Contact Information:Media:Steve
Sabicer, 714-907-6264ssabicer@thesabicergroup.comorInvestors:Susan
Morrison, 858-366-6900 x7005smorrison@tandemdiabetes.comorDexcom
Contact Information:Media:Caren Begun,
856-424-2023caren@greenroom.comorInvestors:Steven Pacelli,
858-200-0200spacelli@dexcom.comorTypeZero Technologies Contact
Information:Media:Meagan Collins,
434-284-8919mcollins@typezero.comorInvestors:Chad Rogers,
434-284-8919rogers@typezero.com
Tandem Diabetes Care (NASDAQ:TNDM)
Historical Stock Chart
From Apr 2024 to May 2024
Tandem Diabetes Care (NASDAQ:TNDM)
Historical Stock Chart
From May 2023 to May 2024