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 an expanded pediatric
indication for the t:slim X2™ insulin pump with Control-IQ™
technology to children age six and older. The product was
previously approved for ages 14 and older. Control-IQ technology is
an advanced hybrid closed-loop feature designed to increase time in
range (70-180 mg/dL).1
Control-IQ technology helps simplify diabetes management for
younger patients by adjusting insulin delivery to help prevent
highs and lows, automatically delivering correction boluses up to
once per hour, and offering exercise and sleep-specific features.
Integrated with Dexcom G6 continuous glucose monitoring (CGM),
Control-IQ technology requires no fingersticks for calibration or
diabetes treatment decisions.2
In a recent six-month study of children age 6 to 13 using the
t:slim X2 pump with Control-IQ technology, sensor time in range
(TIR) increased to 67 percent from 53 percent compared to those in
the control group using sensor-augmented pump (SAP) alone
(p<0.001). Overnight, children using Control-IQ technology in
the same study stayed in range an average of 80 percent of the
time, compared to 54 percent in the control group. This data from
the International Diabetes Closed Loop Protocol-5 (DCLP5) study,
funded by the National Institutes of Health (NIH), was presented
earlier this year at the 13th International Conference on Advanced
Technologies and Treatments for Diabetes (ATTD) in Madrid,
Spain.3
“Nearly 40,000 t:slim X2 users have updated their pump with our
revolutionary Control-IQ technology,” said John Sheridan, president
and CEO of Tandem Diabetes Care. “The overwhelmingly positive
benefits that people report experiencing can now be offered to a
broader group of children with diabetes, which is particularly
important as younger people often struggle with their glucose
control.”
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. 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 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.4
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,5 and the ability
to share real-time CGM data with up to 10 followers.6
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 pumps,7 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.
For additional product and safety information, or to begin
the order process, visit
http://tandemdiabetes.com/controliq
Important Safety Information for the t:slim X2 insulin pump
with Control-IQ technology
Caution: RX ONLY. The t:slim X2 pump and Control-IQ technology
are intended for single patient use. The t:slim X2 pump and
Control-IQ technology are indicated for use with NovoLog or Humalog
U-100 insulin. 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 people 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 t:slim X2 pump is indicated for use in
individuals 6 years of age and greater. 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
iCGM 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 six years of age
and greater.
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, people on dialysis, or critically ill patients. Do not use
Control-IQ technology if using hydroxyurea. Users of the t:slim X2
pump and 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, transmitter, and sensor
must be removed before MRI, CT, or diathermy treatment. Visit
tandemdiabetes.com/safetyinfo for additional important safety
information.
Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects
more than 30 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 500,000 Americans with type
1 diabetes use an insulin pump, or approximately 30 percent of the
type 1 diabetes population. In addition, approximately 100,000
Americans with type 2 diabetes use an insulin pump, which is less
than 10 percent of the type 2 diabetes population using intensive
insulin therapy management.
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 is a registered trademark, and t:slim X2
and Control-IQ 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.
- As measured by CGM
- Zero fingersticks required when using the t:slim X2 pump with
Dexcom G6 CGM integration. 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.
Dexcom 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.
- Wadwa RP. Impact of Control-IQ on glycemic control for school
age children with T1D. Industry Symposium. ATTD, Madrid, Spain;
February 20, 2020.
https://www.youtube.com/watch?v=Tb-2NIify90&feature=youtu.be
- If glucose values are predicted to be above 180 mg/dL,
Control-IQ technology calculates a correction bolus using the
Personal Profile settings and a target of 110 mg/dL and delivers 60
percent of that value. It will do this up to once per hour as
needed. An Automatic Correction Bolus will not occur within 60
minutes of a bolus that has been delivered or cancelled.
- G6 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 G6 readings.
- Requires separate Dexcom Follow app.
- 38% smaller than MiniMed 630G and 670G and at least 28% smaller
than MiniMed 530G, Animas Vibe, and Omnipod System. Data on file,
Tandem Diabetes Care.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200617005216/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
Tandem Diabetes Care (NASDAQ:TNDM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Tandem Diabetes Care (NASDAQ:TNDM)
Historical Stock Chart
From Apr 2023 to Apr 2024