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 Control-IQ™
technology. Control-IQ technology is an advanced hybrid closed-loop
feature designed to help increase time in range (3.9-10 mmol/L)1
and 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
All in-warranty t:slim X2 pump users in Canada will have the
option to add Control-IQ technology to their existing pump
beginning in March 2021 via remote software update. The update will
be free of charge through December 31, 2021.5 Tandem expects to
begin shipping t:slim X2 insulin pumps with Control-IQ technology
in Canada in the first quarter of next year. The company will
continue offering the t:slim X2 insulin pump with Basal-IQ™
predictive low glucose suspend technology for users seeking a
system designed specifically to help prevent lows.
“The t:slim X2 insulin pump with Control-IQ technology is the
most advanced automated insulin dosing system available in the
world and is a testament to our commitment to improving the lives
of people with diabetes,” said John Sheridan, president and CEO of
Tandem Diabetes Care. “We are thrilled to be able to bring the
benefits of this advanced hybrid closed-loop system to the Canadian
diabetes community.”
Control-IQ technology uses Dexcom G6 CGM values to predict
glucose levels 30 minutes ahead and adjust insulin delivery
accordingly; including delivery of automatic correction boluses up
to once per hour. If sensor glucose values are predicted to drop
below 6.25 mmol/L, basal insulin delivery is reduced, and when
predicted to be below 3.9 mmol/L, basal insulin delivery is
stopped. If glucose values are predicted to be above 8.9 mmol/L,
basal insulin delivery will be increased. If glucose values are
predicted to be above 10 mmol/L, Control-IQ technology calculates
an automatic correction bolus with a target of 6.1 mmol/L and
delivers 60 percent of that value. It will do this up to once per
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.
Benefits of Control-IQ Advanced Hybrid
Closed-Loop Technology
Predicts and helps prevent highs and lows – 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 (3.9-10 mmol/L).1
Automatic Correction Boluses – If glucose values are
predicted to be above 10 mmol/L, Control-IQ technology calculates a
correction bolus with a target of 6.1 mmol/L 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 blocking,6 and the ability
to share real-time CGM data with up to 5 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
Colour touchscreen – The large colour 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 pumps,9 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.
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 Control-IQ feature free of charge through
December 31, 2021 via a software update using a personal computer.
Current in-warranty t:slim X2 pump users in Canada will receive
emails 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 Diabetes Care expects the
Control-IQ technology software update to be available for current
t:slim X2 pump users in March 2021. Information about the
requirements and update process is available at
https://www.tandemdiabetes.com/controliq-update
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).6 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
(3.9-10 mmol/L) on average compared to 59 percent in the control
group.1 Sensor time spent above 10 mmol/L was 27 percent per day on
average with Control-IQ technology and 39 percent in the control
group. Sensor time spent below 3.9 mmol/L 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
technology 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.8
Responsible Use of Predictive Technologies
Even with advanced systems such as the t:slim X2 insulin pump
with Control-IQ technology, users are still responsible for
actively managing their diabetes. Control-IQ technology does not
prevent all high and low blood glucose events. The system is
designed to help reduce glucose variability, but it requires
accurate input of information, such as meals and periods of sleep
or exercise. Control-IQ technology will not function as intended
unless all system components are used as instructed, including CGM,
infusion sets, and pump cartridges. Importantly, the system cannot
adjust insulin dosing if the pump is not receiving CGM readings.
Since there are situations and emergencies that the system may not
be capable of identifying or addressing, users must always pay
attention to symptoms and treat according to their healthcare
provider’s recommendations.
Important Safety Information
The t:slim X2 insulin pump and the t:slim X2 insulin pump with
Control-IQ technology are intended for single patient use. The
t:slim X2 pump and the t:slim X2 pump with Control-IQ technology
are indicated for use with NovoRapid or Humalog U-100 insulin.
t:slim X2 insulin pump: The t:slim
X2 pump is intended for the subcutaneous delivery of insulin, at
set and variable rates, for the management of diabetes mellitus in
persons six years of age and greater. The pump is able to reliably
and securely communicate with compatible, digitally connected
devices.
t:slim X2 insulin pump with Control-IQ
technology: The t:slim X2 pump with Control-IQ technology is
intended for use with a compatible continuous glucose monitor (CGM,
sold separately) 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. The
t:slim X2 pump with Control-IQ technology is intended for the
management of Type 1 diabetes mellitus in persons six years of age
and greater.
WARNING: The t:slim X2 pump with 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 25 kilograms.
The t:slim X2 pump with Control-IQ technology is not indicated
for use in pregnant women, people on dialysis, or critically ill
patients. Do not use the t:slim X2 pump with Control-IQ technology
if using hydroxyurea.
Users of the t:slim X2 pump and the t:slim X2 pump with
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 t:slim X2 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.
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 six years old. Tandem is based in San
Diego, California.
Tandem Diabetes Care, Basal-IQ, Control-IQ, and t:slim X2 are
either registered trademarks or trademarks of Tandem Diabetes Care,
Inc. in the United States and/or other countries. Dexcom and Dexcom
G6 are either registered trademarks or trademarks of Dexcom, Inc.
in the United States and/or other countries. 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 in Canada and our ability to offer the
Control-IQ technology 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 Control-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 Control-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.
________________________________
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 Additional training is 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 1,000
mg every six hours. Taking a higher dose may affect the Dexcom G6
CGM 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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201123005640/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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