New Predictive Low Glucose Suspend Feature to
Launch with Dexcom G6 CGM System Integration
Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device
company and manufacturer of the only touchscreen insulin pumps
available in the United States, today announced U.S. Food and Drug
Administration (FDA) approval of the t:slim X2™ Insulin Pump with
Basal-IQ™ technology, a predictive low glucose suspend (PLGS)
feature designed to help reduce the frequency and duration of low
glucose events (hypoglycemia). This is the first automated insulin
delivery system approved for use by children as young as 6 years
old, and the first insulin pump designated as compatible with
integrated continuous glucose monitoring (iCGM) devices. The
Company plans to launch its new product with Dexcom G6® continuous
glucose monitoring (CGM) integration, which requires no
fingersticks for calibration or diabetes treatment decisions and
was the first CGM device to receive the iCGM designation from the
FDA earlier this year.1,2,3 Tandem expects the t:slim X2 Pump with
Basal-IQ technology to be available in August 2018, and all
in-warranty t:slim X2 users in the United States will have the
option to add the new feature free of charge via remote software
update.4
Tandem’s Basal-IQ algorithm is designed to look 30 minutes into
the future to predict where glucose levels are heading. The device
suspends insulin delivery when low glucose is predicted, then
automatically resumes insulin delivery once glucose levels begin to
rise. Use of the t:slim X2 Pump with Basal-IQ technology in the
pivotal clinical study demonstrated a 31 percent relative reduction
in time spent below 70 mg/dL, with no rebound hyperglycemia
compared to a CGM-enabled insulin pump without the feature.
“Hypoglycemia can be a significant source of fear for people who
use insulin and is a major cause of hospitalizations for people
with diabetes,” said Dr. Greg Forlenza, Assistant Professor of
Pediatrics at the Barbara Davis Center, and one of the principal
investigators in the PROLOG (PLGS for
Reduction of Low Glucose) trial. “Basal-IQ technology proved very
effective in the clinical trial at reducing time spent in
hypoglycemia and improving time in range. The system was also
simple to learn and use, so the training burden was minimal for the
clinics and study participants compared to other automated insulin
delivery systems.”
“The t:slim X2 Pump with Basal-IQ technology was designed to
predict and help prevent time spent low using best-in-class CGM
technology,” said Kim Blickenstaff, president and CEO of Tandem
Diabetes Care. “As the first company to launch a touchscreen
insulin pump capable of remote feature updates, and now the first
to have a pump approved with iCGM compatibility, we are delivering
new innovation to our customers at a pace that is unprecedented in
our industry, furthering our mission to help improve the lives of
people with diabetes.”
Benefits of the New Basal-IQ Predictive
Low Glucose Suspend feature:
Predicts and helps prevent lows – Using CGM values, the
Basal-IQ feature looks ahead 30 minutes and suspends insulin when
glucose is predicted to drop below 80 mg/dL or if glucose is
currently below 70 mg/dL and falling. The system resumes insulin
once glucose values start to rise.
No fingersticks – With Dexcom G6 CGM integration, the
Basal-IQ feature works with no fingersticks required for mealtime
dosing or calibration.1 Other benefits of the Dexcom G6 CGM include
an extended 10-day wear, acetaminophen blocking5, and the ability
to share real-time CGM data with up to 5 followers.6
Works silently in the background - No additional alerts
or alarms are required to use Basal-IQ technology compared to
standard CGM-enabled pumps. Users can choose whether or not to
receive alerts when insulin is suspended and resumed based on their
personal preference.
No complicated modes to manage – The Basal-IQ feature has
no complicated settings to manage and operates without constant
input or interaction. The user only has to decide whether they want
the feature on or off.
Standard features of the t:slim X2
Insulin Pump:
Small and discreet – The t:slim X2 Pump is up to 38
percent smaller than other pumps7, yet can hold up to 300-units of
insulin.
Can be used with or without the Basal-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’s California-based
customer support has consistently ranked number one by pump users
in independent patient surveys since 2012.8
For additional product and safety
information, or to begin the order process, visit
www.tandemdiabetes.com/tslimX2or call (877) 801-6901,
Monday – Friday between 6am and 5pm Pacific Time
Free Demo App – Basal-IQ Technology Coming Soon
Tandem’s free t:simulator™ App will be updated in early July to
let you experience the touchscreen interface of the t:slim X2 Pump
with Basal-IQ technology directly on your 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 have
the option to add the Basal-IQ feature free of charge via a
software update using a personal computer. The Basal-IQ feature
update will require a user to secure a new prescription from his or
her healthcare provider and complete a 45-minute online training
module. Internet and computer access are required for pump updates.
Tandem expects the Basal-IQ software update to be available for
current t:slim X2 Pump users in August 2018. Information about the
requirements and update process is available at
www.tandemdiabetes.com/X2update.
Basal-IQ Technology – Clinical Outcomes
In February 2018, the Company reported results from the six-week
PROLOG (PLGS for Reduction of Low Glucose) pivotal trial, a
randomized crossover study comparing two three-week periods of
at-home insulin pump use, one period using the t:slim X2 Pump with
Basal-IQ technology, and another period using a standard
CGM-integrated t:slim X2 Pump without automated insulin suspension.
The study included 103 participants with type 1 diabetes age 6 to
72 at four research centers across the United States. Use of the
system with Basal-IQ technology reduced the number of sensor
glucose readings below 70 mg/dL by 31 percent compared to the
control period using a standard CGM-integrated t:slim X2 Pump
without automated insulin suspension. Importantly, this marked
reduction of time spent in low glucose was accomplished without any
increase in the rate of hyperglycemia and participants
overwhelmingly described the system as simple to learn and
use9.
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 Basal-IQ™ technology. The t:slim
X2 Pump is capable of remote feature updates using a personal
computer, and is the only automated insulin delivery device
approved for children as young as 6 years old. Tandem is based in
San Diego, California.
Tandem Diabetes Care is a registered trademark, and t:slim X2,
Basal-IQ and t:simulator are trademarks of Tandem Diabetes Care,
Inc. Dexcom 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
anticipated timing for the commercial launch of the t:slim X2 with
Basal-IQ and our ability to offer the Basal-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 with Basal-IQ
technology, our ability to launch a new system to facilitate online
training and prescription handling for existing t:slim X2 customers
upgrading their existing devices, and the risk that we may
encounter other challenges that may delay the commercial launch of
t:slim X2 with Basal-IQ, 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 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.2 Dexcom G6 CGM
sold separately3 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.4
A new prescription and additional training are required for this
software update.5 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.6 Separate Follow App required.7 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.8 dQ&A USA Diabetes Connections
Surveys, 2013-20179 Buckingham B, et al. PROLOG: A Randomized
Clinical Trial to Assess The Efficacy of Predictive Low Glucose
Suspend Versus Sensor-Augmented Pump Therapy in The Management of
Type 1 Diabetes [Session #026]. Vienna, Austria: 11th Annual
Advanced Technologies and Treatments for Diabetes Conference;
2018.
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version on businesswire.com: https://www.businesswire.com/news/home/20180621006260/en/
Tandem Diabetes CareMedia:Steve Sabicer,
714-907-6264ssabicer@thesabicergroup.comorInvestors:Susan Morrison,
858-366-6900 x7005IR@tandemdiabetes.com
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