Automated
Insulin Dosing Software First to Receive New Classification by
FDA
Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, today announced U.S. Food
and Drug Administration (FDA) clearance 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,
and the first 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 Control-IQ
technology for the t:slim X2 insulin pump is the first automated
insulin dosing software in a new interoperable automated glycemic
controller category that automatically adjusts insulin delivery to
a person with diabetes by connecting to an alternate
controller-enabled insulin pump (ACE pump) and integrated
continuous glucose monitor (iCGM). This is the third category
classified by the FDA for the interoperability of devices as a
complete automated insulin dosing (AID) system.
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The t:slim X2 insulin pump with
Control-IQ technology from Tandem Diabetes Care (Photo: Business
Wire)
All in-warranty t:slim X2 pump users in the United States will
have the option to add the new feature free of charge via remote
software update.5 The update is expected to be available by the end
of January 2020, and new pumps with Control-IQ technology will
begin shipping to customers in the same timeframe. The Company will
continue to offer the t:slim X2 pump with Basal-IQ® predictive low
glucose suspend technology as an option for people who prefer a
system designed specifically to help prevent lows.
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 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 the treatment values to better match the different
physiologic needs during these activities.
With the interoperable automated glycemic controller
designation, the FDA establishes a new device class which includes
special controls outlining requirements for this and future
submissions in this category, as well as describes the reliability,
device interoperability, cybersecurity, and clinical relevance data
required to demonstrate acceptable performance. The t:slim X2
insulin pump was also the first to receive an ACE infusion pump
classification in February 2019, and the first insulin pump
designated as compatible with iCGM devices in June 2018.
More information on the new interoperable automated glycemic
controller classification can be found in the press release issued
by the FDA earlier today.
https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-automated-insulin-dosing-controller-designed-allow-more-choices
“Not only do new closed-loop systems need to be effective at
improving glycemic control, they must also be easy to understand
and use so patients can experience the full benefits of the
technology. The t:slim X2 insulin pump with Control-IQ technology
successfully achieved both objectives in the clinical studies,”
said Boris Kovatchev, PhD, Director of the Center for Diabetes
Technology at the University of Virginia and principal investigator
of the International Diabetes Closed Loop (iDCL) trials. “We are
very proud of the extensive academic research that went into this
effort, and we are thrilled to see this work has translated into an
FDA-cleared device for clinical use so that more people can
experience the benefits of this technology.”
“With this clearance, we will be launching the most advanced
automated insulin dosing system commercially available in the world
today,” said John Sheridan, president and CEO of Tandem Diabetes
Care. “This is a testament to our commitment to improving the lives
of people with diabetes by offering simple-to-use products that
deliver superior performance.”
“The approval of the Control-IQ system with Dexcom G6 CGM brings
together two incredible products to deliver a powerful automated
insulin dosing solution for people with diabetes,” said Kevin
Sayer, president and CEO of Dexcom. “Sensor accuracy is a critical
component for automated insulin dosing, and we are excited that
Dexcom G6 users can benefit from our collaborative effort to
integrate this advanced hybrid closed loop system.”
Benefits of Control-IQ Advanced Hybrid
Closed-Loop Technology:
Predicts and helps prevent lows and highs – Control-IQ
technology uses CGM readings to predict glucose values 30 minutes
ahead and can increase, decrease or stop basal insulin delivery to
help keep glucose in range (70-180 mg/dL).1
Automatic Correction Boluses – 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. It will do this up to once an hour as needed.
Accommodates for sleep and exercise – Control-IQ
technology offers optional settings for sleep and exercise that
change the treatment values to better match the different
physiologic needs during these activities.
No fingersticks – With Dexcom G6 CGM integration, the
Control-IQ feature works with no fingersticks required for mealtime
dosing or calibration.2 Other benefits of the Dexcom G6 CGM include
an extended 10-day wear, acetaminophen blocking6, and the ability
to share real-time CGM data with up to 10 followers.7
Easy to use – The system has no complicated criteria to
keep Control-IQ technology on. If the CGM signal is temporarily
lost, the Control-IQ feature will resume automatically when the CGM
is back in range. In the pivotal study, participants gave
Control-IQ technology a 4.7 out of 5.0 for ease of use, and a 4.8
out of 5.0 for desire to continue use of the system.8
Standard Features of the t:slim X2
Insulin Pump:
Color touchscreen – The large color touchscreen on the
t:slim X2 pump is easy to read, simple to learn, and intuitive to
use for anyone familiar with a smartphone or tablet.
Small and discreet – The t:slim X2 pump is up to 38
percent smaller than other pumps9, yet can hold up to 300-units of
insulin.
Can be used with or without the Control-IQ feature or CGM
– When advanced features are turned off, the t:slim X2 pump removes
the CGM chart from the screen and puts the Bolus and Option buttons
front and center for easy access.
#1-rated customer support – Tandem Diabetes Care customer
support has been consistently ranked number one by pump users in
independent patient surveys since 2013.10
For additional product and safety
information, or to begin the order process, visit
http://tandemdiabetes.com/controliq
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.
Free Software Update for Current t:slim X2 Pump Users
All in-warranty t:slim X2 pump users in the United States will
have the option to update their pumps with the Control-IQ feature
free of charge via a software update using a personal computer. The
Control-IQ feature update will require a user to secure a new
prescription from his or her healthcare provider and complete an
online training module. Internet and computer access are required
for pump updates. All eligible t:slim X2 pump users will receive an
email with more information on the update process in the coming
days. Tandem expects the Control-IQ software update to be available
for current t:slim X2 pump by the end of January 2020. Information
about the requirements and update process is available at
www.tandemdiabetes.com/X2update.
Control-IQ Technology – Clinical Outcomes
Data from the NIH-funded DCLP3 study, published by the New
England Journal of Medicine in October 2019, compared use of a
t:slim X2 insulin pump with Control-IQ technology and Dexcom G6 CGM
integration (n=112) to a control group using a t:slim X2 pump with
just Dexcom G6 CGM integration (n=56).8 This study was the first
large-scale 6-month closed loop study to include a dedicated
control group. There were no exclusion criteria based on hemoglobin
A1c, history of acute complications, or previous experience using
an insulin pump, and all participants completed the study. Those
using Control-IQ technology experienced 71 percent time in range
(70-180 mg/dL) per day on average compared to 59 percent in the
control group.1 Sensor time spent above 180 mg/dL was 27 percent
per day on average with Control-IQ technology and 39 percent in the
control group. Sensor time spent below 70 mg/dL was 1.4 percent per
day on average with Control-IQ technology and 1.9 percent in the
control group. The system remained connected to CGM with Control-IQ
on and active an average of 92 percent of the 26-week study period.
In a five-point survey at the end of the study, users
overwhelmingly rated the Control-IQ system as simple to use, giving
it a 4.5 for trust, a 4.7 for ease of use, and a 4.8 for desire to
continue using the system.
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.
Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects
more than 29 million people in the United States, or nearly 1 in 10
Americans. Tandem estimates that more than three million people in
the United States require daily administration of insulin and are
candidates for pump therapy. More than 425,000 Americans with type
1 diabetes use an insulin pump, or approximately 27 percent of the
type 1 diabetes population. In addition, approximately 125,000
Americans with type 2 diabetes use an insulin pump, a small
fraction of the type 2 diabetes population.
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, and is the only automated insulin dosing device approved
for children as young as 6 years old. Tandem is based in San Diego,
California.
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. 5 A new
prescription and additional training are required for this software
update. 6 Dexcom G6 CGM readings can be used to make diabetes
treatment decisions when taking up to a maximum acetaminophen dose
of 1,000mg every 6 hours. Taking a higher dose may affect the G6
readings. 7 Separate Follow App required. 8 Brown SA, Kovatchev D,
Raghinaru JW, et al. Six-Month Randomized, Multicenter Trial of
Closed-Loop Control in Type 1 Diabetes. N Engl J Med.
2019;381(18):1707-17. DOI: 10.1056/NEJMoa1907863 9 38 percent
smaller than MiniMed 630G and 670G and at least 28 percent smaller
than MiniMed 530G, Animas Vibe and Omnipod System. Data on file,
Tandem Diabetes Care. 10 dQ&A USA Diabetes Connections Surveys,
2013-2019
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version on businesswire.com: https://www.businesswire.com/news/home/20191213005424/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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