Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, today announced Health
Canada approval of the t:slim X2™ insulin pump with Basal-IQ™
technology. Basal-IQ technology, a predictive low-glucose suspend
(PLGS) algorithm, utilizes sensor values from an integrated Dexcom
G6 continuous glucose monitor (CGM) to help reduce the frequency
and duration of low-glucose events (hypoglycemia). All in-warranty
t:slim X2 pump users in Canada will have the option to add Basal-IQ
technology to their existing pump free of charge via remote
software update in February 2020.1 Tandem expects to begin shipping
t:slim X2 pumps with Basal-IQ technology to new customers in the
first quarter of 2020.
“The t:slim X2 insulin pump with Basal-IQ technology has
received overwhelmingly positive feedback from current users and we
are thrilled to bring its benefits to our customers in Canada,”
said John Sheridan, president and CEO of Tandem Diabetes Care. “Our
ability to provide in-warranty t:slim X2 pump users a software
update to add Basal-IQ technology to their current pumps using a
personal computer is unparalleled in the industry and further
differentiates the t:slim X2 insulin pump from other devices on the
market.”
Benefits of Basal-IQ
Technology:
Predicts and helps prevent lows – Using Dexcom G6 CGM
values, the Basal-IQ feature looks ahead 30 minutes and suspends
insulin when glucose is predicted to drop below 4.4 mmol/L (80
mg/dL) or if glucose is currently below 3.9 mmol/L (70 mg/dL). The
system resumes insulin once sensor 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. Other benefits of the Dexcom G6 CGM include
an extended 10-day wear, acetaminophen blocking2, and the ability
to share real-time CGM data with up to 10 followers.3
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 pumps4, 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.
For additional product availability and
safety information in Canada, visit www.tandemdiabetes.ca.
Free Demo App – Basal-IQ Technology Coming Soon
Using the free t:simulator™ app, people will soon be able to
experience the touchscreen interface of the t:slim X2 pump with
Basal-IQ technology directly on their 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 Canada will have the
option to add the Basal-IQ feature free of charge via a software
update using a personal computer. Current in-warranty t:slim X2
pump users in Canada will receive emails in the next few weeks with
more information about the process, including a link to a 30 to
45-minute online training module which must be completed prior to
updating their pump. 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 February 2020.
Information about the requirements and update process is available
at www.tandemdiabetes.com/update.
Basal-IQ Technology – Clinical Outcomes
In a six-week pivotal trial (n=103), 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 CGM-integrated t:slim X2 pump without
automated insulin suspension, use of Basal-IQ technology reduced
the number of sensor glucose readings below 3.9 mmol/L (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 sensor time below 3.9 mmol/L
(70 mg/dL) was accomplished without any increase in the rate of
hyperglycemia and participants overwhelmingly described the system
as simple to learn and use.5 Data published on real-world use of
Basal-IQ technology has demonstrated even greater reductions in
time spent below 3.9 mmol/L (70 mg/dL) than seen in the pivotal
trial.6
Diabetes in Canada
According to Diabetes Canada (www.diabetes.ca), there are more
than 3.4 million Canadians living with diabetes, of which
approximately 10 percent have type 1 diabetes.7 Insulin pumps and
diabetes supplies are a covered benefit for qualifying recipients
of disability tax credit, assistive devices programs, and
qualifying expenses for registered disability savings plans offered
in various forms across Canadian provinces.8
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 and Basal-IQ are trademarks of Tandem
Diabetes Care, Inc., registered in the United States and other
countries. t:slim X2 and t:simulator are trademarks of Tandem
Diabetes Care, Inc. Dexcom and Dexcom G6 are trademarks of Dexcom,
Inc., registered in the United States and other countries. All
other third-party marks are the property of their respective
owners.
Important Safety Information for the t:slim X2 Insulin Pump
with Basal-IQ Technology
Caution: Federal (USA) law restricts this device to sale by or
on the order of a physician. The t:slim X2 insulin pump with
Basal-IQ technology (the System) consists of the t:slim X2 insulin
pump, which contains Basal-IQ technology, and a compatible CGM. CGM
sold separately. The t:slim X2 insulin 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 t:slim X2 insulin pump can be used solely for continuous
insulin delivery and as part of the System. When the System is used
with a compatible iCGM, Basal-IQ technology can be used to suspend
insulin delivery based on CGM sensor readings. The System is
indicated for use in individuals 6 years of age and greater. The
System is intended for single patient use. The System is indicated
for use with NovoLog/NovoRapid or Humalog U-100 insulin. The System
is not approved for use in pregnant women, persons on dialysis, or
critically ill patients. The pump is not intended for anyone unable
or unwilling 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; and see their healthcare
provider regularly. The user must also have adequate vision and/or
hearing to recognize all functions of the pump, including alerts.
For detailed indications for use and safety information, visit
tandemdiabetes.com/safetyinfo.
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 Basal-IQ technology in Canada and our ability to offer the
Basal-IQ software update for current t:slim X2 pump users in
Canada. These statements are subject to numerous risks and
uncertainties, including our ability to obtain and retain
registration as an approved vendor for provincial device
reimbursement programs, our ability to fulfill commercial demand
for the t:slim X2 with Basal-IQ technology, our ability to
facilitate online training for existing t:slim X2 customers
upgrading their devices, and the risk that we may encounter other
challenges that may delay the commercial launch of the t:slim X2
pump with Basal-IQ technology in Canada, 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.
* If glucose alerts and CGM readings do not match symptoms or
expectations, use a blood glucose meter to make diabetes treatment
decisions. Dexcom G6 CGM sold separately.
1 Additional training is required for this software update.
2 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.
3 Separate Follow App required.
4 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.
5 Forlenza GP, Li Z, Buckingham BA, Pinsker JE, et al.
Predictive low glucose suspend reduces hypoglycemia in adults,
adolescents, and children with type 1 diabetes in an at-home
randomized crossover study: Results of the PROLOG trial. Diabetes
Care. 2018;41(10): 2155-2161. DOI:10.2337/dc18-0771.
6 Muller L, Habif S, Leas S, Aronoff-Spencer E. Reducing
Hypoglycemia in the Real World: A Retrospective Analysis of
Predictive Low-Glucose Suspend Technology in an Ambulatory
Insulin-Dependent Cohort. Diab Technol Ther. 2019;21(9):474-484.
DOI: 10.1089/dia.2019.0190
7 Estimated diabetes statistics in Canada are generated by the
Canadian Diabetes Cost Model; 2015.
8
http://www.diabetes.ca/about-cda/public-policy-position-statements/access-to-diabetes-medication-supplies-medical-devices.
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version on businesswire.com: https://www.businesswire.com/news/home/20191120005287/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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