Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, today announced its
commercial launch of the t:slim X2™ insulin pump with Control-IQ™
technology, an advanced hybrid-closed loop feature designed to help
increase time in range (70-180 mg/dL)1. It is the first and only
system cleared to deliver automatic correction boluses in addition
to adjusting insulin to help prevent high and low blood sugar. The
system integrates with Dexcom G6 continuous glucose monitoring
(CGM), which requires no fingersticks for calibration or diabetes
treatment decisions.2,3,4 The Company will soon begin sending
emails with update instructions to all in-warranty t:slim X2 users
in the United States, who have the option to add the new feature
free of charge via remote software update. t:slim X2 pumps
pre-loaded with Control-IQ technology are now shipping to new
customers.
The t:slim X2 insulin pump with Control-IQ technology uses CGM
values, in conjunction with other variables such as insulin on
board, to predict sensor glucose levels 30 minutes ahead and adjust
insulin delivery accordingly. If glucose values are predicted to
drop below 112.5 mg/dL, basal insulin delivery is reduced, and when
predicted to be below 70 mg/dL, basal insulin delivery is stopped.
If glucose values are predicted to be above 160 mg/dL in the next
30 minutes, basal insulin will be increased. If glucose values are
predicted to be above 180 mg/dL, Control-IQ technology calculates a
correction bolus with a target of 110 mg/dL, and delivers 60
percent of that value up to once an hour as needed. Control-IQ
technology also offers optional settings for sleep and exercise
that will change treatment values to better match the different
physiologic needs during these activities.
“Control-IQ technology has been described by study participants
and investigators as ‘life-changing,’ ‘easy to use,’ and ‘a new
standard of care in insulin therapy management,’ which is
incredible feedback as we commence this commercial launch and begin
bringing its benefits to more people with diabetes,” said John
Sheridan, President and Chief Executive Officer. “We began
processing orders earlier this month and are excited about the
opportunity this launch presents for 2020. As these new customers
move through the insurance verification process it will provide us
with valuable trend information that will be used in setting our
financial guidance for the year.”
Update Instructions for Current t:slim X2 Pump Users
No action is required at this time. Individual emails are being
sent to all in-warranty t:slim X2 pump users in the United States
with information on how to start the update process. Emails are
being sent out in batches, with all users anticipated to have
received the information by the end of January. The Control-IQ
technology update will require a new prescription and completion of
online training, all of which will be coordinated through a
simple-to-use online portal. Internet and computer access are
required for pump updates. Control-IQ technology is only compatible
with the Dexcom G6 CGM System. t:slim X2 insulin pumps updated to
Control-IQ technology cannot revert to previous software versions
following this software update. More information about the update
process and system requirements is available at
www.tandemdiabetes.com/X2update.
Free Demo App – Control-IQ Technology
Tandem’s free t:simulator™ app lets people experience the
touchscreen interface of the t:slim X2 pump with Control-IQ
technology directly on a mobile device. For more information and to
download the app, visit
http://www.tandemdiabetes.com/tsimulator.
For additional product and safety
information, or to begin the order process, visit
www.tandemdiabetes.com/controliq
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 with Control-IQ technology. The t:slim
X2 pump is capable of remote feature updates using a personal
computer. Tandem is based in San Diego, California.
Important Safety Information for the t:slim X2 Insulin Pump
with Control-IQ Technology
Caution: Federal (USA) law restricts the t:slim X2 insulin pump
and Control-IQ technology to sale by or on the order of a
physician.
Indications for Use:
t:slim X2 insulin pump
The t:slim X2 insulin pump with interoperable technology is an
alternate controller enabled (ACE) pump that is intended for the
subcutaneous delivery of insulin, at set and variable rates, for
the management of diabetes mellitus in persons requiring insulin.
The pump is able to reliably and securely communicate with
compatible, digitally connected devices, including automated
insulin dosing software, to receive, execute, and confirm commands
from these devices. The pump is indicated for use in individuals 6
years of age and greater. The pump is intended for single patient,
home use and requires a prescription. The pump is indicated for use
with NovoLog or Humalog U-100 insulin.
Control-IQ technology
Control-IQ technology is intended for use with a compatible
integrated continuous glucose monitor (iCGM, sold separately) and
ACE pump to automatically increase, decrease, and suspend delivery
of basal insulin based on CGM readings and predicted glucose
values. It can also deliver correction boluses when the glucose
value is predicted to exceed a predefined threshold. Control-IQ
technology is intended for the management of Type 1 diabetes
mellitus in persons 14 years of age and greater. Control-IQ
technology is intended for single patient use. Control-IQ
technology is indicated for use with NovoLog or Humalog U-100
insulin.
Contraindications and Warnings:
BOXED WARNING: Control-IQ
technology should not be used by anyone under the age of six years
old. It should also not be used in patients who require less than
10 units of insulin per day or who weigh less than 55 pounds.
Control-IQ technology is not indicated for use in pregnant
women, persons on dialysis, or critically ill patients.
Users of the t:slim X2 pump and Control-IQ technology must:
- be able and willing to use the insulin pump, CGM, and all other
system components in accordance with their respective instructions
for use;
- test blood glucose levels as recommended by their healthcare
provider;
- demonstrate adequate carb-counting skills;
- maintain sufficient diabetes self-care skills;
- see healthcare provider(s) regularly; and
- have adequate vision and/or hearing to recognize all functions
of the pump, including alerts, alarms, and reminders;
The t:slim X2 pump, transmitter, and sensor must be removed
before MRI, CT, or diathermy treatment. For additional important
safety information, visit tandemdiabetes.com/safetyinfo.
Tandem Diabetes Care and Basal-IQ are registered trademarks, and
t:slim X2, Control-IQ and t:simulator are trademarks of Tandem
Diabetes Care, Inc. Dexcom and Dexcom G6 are registered trademarks
of Dexcom, Inc. All other third-party marks 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
anticipated timing for the commercial launch of the t:slim X2 pump
with Control-IQ technology and our ability to offer the Control-IQ
software update for current t:slim X2 pump users. These statements
are subject to numerous risks and uncertainties, including our
ability to commence commercial scale manufacturing of the t:slim X2
pump with Control-IQ technology, our ability to operate and
maintain a system to facilitate online training and prescription
handling for existing t:slim X2 pump customers upgrading their
existing devices, and the risk that we may encounter other
challenges that may delay the commercial launch of t:slim X2 pump
with Control-IQ technology, as well as other risks identified in
our most recent Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q, 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. 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 As measured by CGM
2 If glucose alerts and CGM readings do not match symptoms or
expectations or if taking over the recommended maximum dosage
amount of 1000mg of acetaminophen every 6 hours, use a blood
glucose meter to make diabetes treatment decisions.
3 Dexcom G6 CGM sold separately
4 The Dexcom G6 CGM transmitter can only be paired with one
medical device (either a Dexcom receiver or t:slim X2 pump) and one
consumer device (phone or tablet) at the same time.
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version on businesswire.com: https://www.businesswire.com/news/home/20200115005808/en/
Tandem Diabetes Care Contact Information: Media: Steve
Sabicer, 714-907-6264, ssabicer@thesabicergroup.com Investors:
Susan Morrison, 858-366-6900 x7005, IR@tandemdiabetes.com
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