Tandem Diabetes Care Reports Successful Completion of First Pilot Study Using t:slim X2 Insulin Pump with TypeZero Hybrid Clo...
January 08 2018 - 09:15AM
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 reported the successful
completion of the first pilot study using a hybrid closed loop
system featuring its t:slim X2™ Insulin Pump with embedded
algorithms from TypeZero Technologies and integration with Dexcom®
G6 Continuous Glucose Monitoring (CGM). This pilot study was the
first of three in the National Institute of Health (NIH)-funded
International Diabetes Closed Loop (IDCL) Trial using the t:slim X2
Pump running the algorithm directly on the pump. The second study
is now moving forward with enrollment at seven clinical sites and
is anticipated to begin in the first quarter of 2018. The IDCL
Trial is expected to conclude with a pivotal study in 2018, and
Tandem plans to use this data in a PMA submission to the U.S. Food
and Drug Administration.
The hybrid closed loop 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, the system also automates
correction boluses. The hybrid closed loop software developed by
TypeZero 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 30 clinical studies involving
more than 450 participants, with data referenced in a number of
journal articles.1
“The first successful use of the commercial version of our
hybrid closed loop system is a huge step forward, and the speed of
the development cycle for this product has been impressive for our
industry,” said Kim Blickenstaff, president and CEO of Tandem
Diabetes Care. “We look forward to starting the pivotal study later
this year and continue to prepare for a launch in the first half of
2019, subject to FDA approval.”
“We have enjoyed introducing patients to this latest advancement
in technology, featuring an easy-to-use system and an algorithm
with a successful track record in past clinical trials of improving
blood glucose control while simultaneously decreasing
hypoglycemia,” said Sue Brown, Associate Professor at the Center
for Diabetes Technology at the University of Virginia and the
endocrinologist in charge of the IDCL trials using this embedded
technology. “This study was an exciting step forward in closed-loop
technology for people with diabetes.”
“Sensor accuracy is a critical component for automated insulin
delivery, and we are excited to have the first integration of
Dexcom’s next-generation G6 CGM technology in this hybrid closed
loop system,” said Steve Pacelli, Executive Vice President of
Strategy and Corporate Development at Dexcom. “We are proud to
partner with Tandem in the IDCL trial and are thrilled to see this
integrated product moving forward into multi-center studies.”
The IDCL Trial started in late 2016 and is expected to include
up to 360 adults with type 1 diabetes across all of its studies.
Earlier phases of the IDCL used a Tandem insulin pump and Dexcom G5
sensor as part of a blood glucose control system that combined
these devices with a smartphone running TypeZero’s inControl closed
loop algorithms. The latest series of studies, now using the
fully-integrated system, began with the supervised 36 to 48-hour
pilot study in 5 subjects conducted at the University of Virginia.
The next study, scheduled to take place in early 2018, will be a
two-week, at-home study with enrollment at seven centers across the
United States. A pivotal trial is planned to take place at these
same centers following successful completion and review of the
two-week study.
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, now available with
Dexcom G5® Mobile CGM integration, and the t:flex® Insulin Pump,
the first pump designed for people with greater insulin
requirements. Tandem is based in San Diego, California.
Tandem Diabetes Care and t:flex are registered trademarks, and
t:slim X2 is a trademark of Tandem Diabetes Care, Inc. Dexcom,
Dexcom G5 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
timing of anticipated enrollment, commencement and completion of
the remaining studies that comprise the IDCL trial, whether the
data from the IDCL trial will be adequate to support a future
regulatory filing by Tandem and the anticipated launch of an
integrated product in the first half of 2019. These statements are
subject to numerous risks and uncertainties, including the risk
that each of the remaining studies that comprise the IDCL trial
will be completed as currently contemplated, 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 a future
regulatory filing, 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 that 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. 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.
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Tandem Diabetes CareMedia:Steve Sabicer,
714-907-6264ssabicer@thesabicergroup.comorInvestors:Susan Morrison,
858-366-6900 x7005smorrison@tandemdiabetes.com
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