Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, today announced
presentation of real-world data from pediatric users of the t:slim
X2™ insulin pump with Basal-IQ® predictive low-glucose suspend
technology at the 45th annual conference of the International
Society for Pediatric and Adolescent Diabetes (ISPAD). Data from
2,696 users under the age of 18 years old showed an overall rate of
hypoglycemia of only 0.9 percent when using Basal-IQ technology. A
subgroup of users with at least 21 days of sensor-augmented pump
data prior to use of Basal-IQ technology demonstrated a 31 percent
reduction in hypoglycemia following introduction of the feature
(n=491).
Data Highlights
The study included de-identified real-world data uploaded to
Tandem’s t:connect® web application between August 31, 2018 and
March 14, 2019, which was retrospectively analyzed to assess
hypoglycemia outcomes.
Overall Group (n=2,696) – The overall rate of hypoglycemia
(defined as percent median time spent with sensor readings <70
mg/dL or 3.9 mmol/L) for this group was 0.9 percent.
Algorithm-enabled insulin suspensions occurred on average 4.9 times
per day for an average 15.5 minutes per suspension.
Subgroup (n=491) – Pre-post analysis demonstrated median time
spent <70 mg/dL or 3.9 mmol/L decreased from 1.6 to 1.1 percent
upon introduction of Basal-IQ technology (p = <0.001),
representing a 31 percent reduction in hypoglycemia. Sensor
time-in-range (defined as 70-180 mg/dL or 3.9-10.0 mmol/L) remained
steady between pre- and post-Basal-IQ technology use, however,
there was a significant decrease in sensor glucose values greater
than 300 mg/dL or 16.7 mmol/L (p=0.007).
About the t:slim X2 Insulin Pump with Basal-IQ
Technology
The simple-to-use t:slim X2 insulin pump with Basal-IQ
predictive low glucose suspend technology uses glucose values from
an integrated Dexcom G6 continuous glucose monitor to predict and
help prevent lows with zero fingersticks*. The t:slim X2 insulin
pump includes advanced features like a large color touchscreen,
rechargeable battery, Bluetooth® wireless technology, USB
connectivity and watertight construction (IPX7)1. It is capable of
remote software updates using a personal computer, offering the
potential for in-warranty users to access new features as they meet
necessary regulatory requirements2. The t:slim X2 insulin pump is
up to 38 percent smaller than other insulin pumps and holds up to
300 units of insulin.3
Launch of the t:slim X2 insulin pump with Basal-IQ technology
has begun in select international geographies. It is currently
available on new t:slim X2 insulin pumps and as a software update
to all in-warranty t:slim X2 insulin pump users in the United
Kingdom, Sweden, Denmark, Spain, Italy, the Czech Republic, and
South Africa.
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’s flagship product,
the t:slim X2 insulin pump, is capable of remote software updates
using a personal computer and features integrated continuous
glucose monitoring. Tandem is based in San Diego, California.
Tandem Diabetes Care, t:connect, and Basal-IQ are registered
trademarks, and t:slim X2 is a trademark of Tandem Diabetes Care,
Inc. Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc.
The Bluetooth wordmark is a registered trademark owned by Bluetooth
SIG, Inc. and any use of such mark by Tandem Diabetes Care, Inc. is
under license. 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
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 and requires a
prescription. 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; 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
ability of the t:slim X2 pump to provide remote feature updates,
the timing and outcome of regulatory approvals for new product
features and updates, and the ability of our products to improve
customer satisfaction and clinical outcomes. These statements are
subject to numerous risks and uncertainties, including the risks
that technical problems may prevent or delay remote software
updates, regulatory agencies may fail to approve new product
features or updates on our expected timeframe or at all, and the
level of customer satisfaction from the use of our products and
features may be different from what we expect, as well as other
risks identified in Tandem’s most recent Annual Report on Form 10-K
and Quarterly Reports on Form 10-Q, respectively, and other
documents 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 Tested to a depth of 3 feet for 30 minutes 2 Additional
feature updates are not currently available for the t:slim X2
insulin pump with Basal-IQ technology and are subject to future FDA
approvals. A prescription and additional training may be required
to access certain future software updates. 3 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20191030005928/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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