Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, today announced U.S. Food
and Drug Administration (FDA) clearance for the Tandem Mobi insulin
pump for people with diabetes age 6 and up, expanding the company’s
portfolio of products. The Tandem Mobi is fully controllable from a
mobile app and is the world’s smallest durable automated insulin
delivery system.1
“Testing the limits of pump miniaturization, Tandem Mobi joins
the t:slim X2 pump in our family of insulin delivery solutions
bringing new options in wearability, the flexibility to disconnect,
and full phone control,” said John Sheridan, president and chief
executive officer. “Through this expansion, we are delivering on
our commitment to bring greater choice, along with the proven
benefits of Tandem’s technology, to more people living with
diabetes.”
Key Tandem Mobi System Features:
The Tandem Mobi features a 200-unit insulin cartridge and an
on-pump button that provides an alternative option to phone control
for bolusing insulin. Additional features include:
- Multiple Wear Options – Less than half the size of the t:slim
X2 pump, Tandem Mobi can fit in a coin pocket, be clipped to
clothing, or worn on-body with an adhesive sleeve (sold
separately).
- Detachable Infusion Sets – Compatible with all existing
Tandem-branded infusion sets manufactured by the Convatec Group,
including a new five-inch tubing option made just for Tandem Mobi.
Infusion sets allow users to temporarily disconnect from their pump
for convenience and provide the flexibility of more than 30
mix-and-match infusion site and tubing length combinations.
- AID Compatibility – Designed for use as part of an automated
insulin delivery (AID) system, the Tandem Mobi features Control-IQ
technology.
- Mobile App Control – Full iOS mobile control through a user’s
compatible iPhone
- Modern Technology – Inductive charging and capable of wireless
remote software updates via a compatible smartphone
A limited release of Tandem Mobi is expected to start in late
2023 with full commercial availability planned in early 2024. To
sign up for notifications, please visit
tandemdiabetes.com/mobi.
About Control-IQ Advanced Hybrid Closed-Loop
Technology
The Tandem Mobi will be offered with Control-IQ technology, a
hybrid-closed loop algorithm for use by people with type 1 diabetes
age 6 and up. Control-IQ technology uses compatible continuous
glucose monitoring (CGM) sensor values to predict glucose levels 30
minutes ahead and adjust insulin delivery every 5 minutes to help
prevent highs and lows, while still allowing the user to manually
bolus for meals. It can also deliver automatic correction boluses
(up to one an hour) to help prevent hyperglycemia.2 Real-world data
shows immediate and sustained glycemic improvements — including
more time in range and better sleep.3 Results from major studies of
Control-IQ technology were published by the New England Journal of
Medicine in October 2019, August 2020, and March 2023.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc., a global insulin delivery and
diabetes technology company based in San Diego, California, creates
new possibilities for people living with diabetes, their loved
ones, and healthcare providers through a positively different
experience. The company’s human-centered approach to design,
development, and support delivers innovative products and services
for people who use insulin. Tandem manufactures and sells the
t:slim X2 insulin pump with Control-IQ technology. For more
information, visit tandemdiabetes.com.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use
#tslimX2 and #TandemDiabetes. Follow Tandem Diabetes Care on
Facebook at facebook.com/TandemDiabetes. Follow Tandem Diabetes
Care on LinkedIn at linkedin.com/company/tandemdiabetes.
Forward-looking Statements
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. These forward-looking statements relate to, among other
things, the anticipated timing for the limited release and
subsequent commercial launch of the Tandem Mobi system. These
forward-looking statements are subject to numerous risks and
uncertainties, including risks associated with the commercial
launch of a new product, as well as manufacturing risks and risks
related to adequate reimbursement coverage. These and other risks
are identified and described in greater detail under the “Risk
Factors” heading of our most recent Annual Report on Form 10-K.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release. Actual results could differ materially from those
anticipated or projected in the forward-looking statements. 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.
Indications for Use
Tandem Mobi insulin pump: The Tandem Mobi insulin pump
with interoperable technology (the pump) 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 intended for single patient, home use and requires a
prescription. The pump is indicated for use in individuals six
years of age and greater.
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
people 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 six years of age and greater. The pump is intended for
single patient use. The pump is indicated for use with U-100
insulin only.
Control-IQ technology: Control-IQ technology is intended
for use with a compatible iCGM (sold separately) and ACE pump to
automatically increase, decrease, and suspend delivery of basal
insulin based on iCGM 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 six years
of age and greater. Control-IQ technology is intended for single
patient use. Control-IQ technology is indicated for use with U-100
insulin only.
Responsible use of Control-IQ technology
Control-IQ technology does not prevent all highs and lows. Users
must still bolus for meals and actively manage their diabetes.
Visit tandemdiabetes.com/safetyinfo for additional important safety
information.
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, people on dialysis, or critically ill patients. Do not use
Control-IQ technology if using hydroxyurea. Users of a Tandem
insulin pump and Control-IQ technology must: 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 Tandem pump, and the
CGM transmitter and sensor must be removed before MRI, CT, or
diathermy treatment. Visit tandemdiabetes.com/safetyinfo for
additional important safety information.
© 2023 Tandem Diabetes Care, Inc. All rights reserved. Tandem
Diabetes Care, the Tandem logo, Control-IQ, Tandem Mobi and t:slim
X2 are either registered trademarks or trademarks of Tandem
Diabetes Care, Inc. in the United States and/or other countries.
All third-party marks are the property of their respective
owners.
________________________ 1 As of July 2023. Data on file, Tandem
Diabetes Care. 2 If glucose values are predicted to be above 180
mg/dL, Control-IQ technology calculates a correction bolus using
the Personal Profile settings and a target of 110 mg/dL and
delivers 60% of that value. An Automatic Correction Bolus will not
occur within 60 minutes of a bolus that has been delivered or
cancelled. 3 Breton MD, Kovatchev BP. One-year real-world use of
the Control-IQ advanced hybrid closed-loop technology. Diabetes
Technol Ther. 2021;23(9):601-608. doi: 10.1089/dia.2021.0097
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version on businesswire.com: https://www.businesswire.com/news/home/20230711513669/en/
Media Contact: 858-255-6388 media@tandemdiabetes.com
Investor Contact: 858-366-6900 IR@tandemdiabetes.com
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