NIH-funded International Diabetes Closed Loop (IDCL) Trial to Combine Technologies from Tandem Diabetes Care, Dexcom and TypeZero
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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
"The IDCL Trial is designed as a pivotal trial of a closed-loop
control-to-range system, and includes seven institutions in the
"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
"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
"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
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
About
About
About
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.
t:slim, t:flex, and
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
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 Care Contact Information:
Media:
ssabicer@thesabicergroup.com
or
Investors:
smorrison@tandemdiabetes.com
or
Media:
caren@greenroom.com
or
Investors:
spacelli@dexcom.com
or
Media:
mcollins@typezero.com
or
Investors:
rogers@typezero.com
Source:
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