Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, today presented positive
real-world data from early use of the t:slim X2™ insulin pump with
Control-IQ™ advanced hybrid closed loop technology, demonstrating
statistically significant improvements in sensor Time in Range
(70-180 mg/dL) in people living with both type 1 and type 2
diabetes with no increase in hypoglycemia (<70 mg/dL). The data
was presented in two separate poster presentations this morning
during the 80th Scientific Sessions of the American Diabetes
Association.
“We are proud to see that early adopters of Control-IQ
technology are experiencing real-world outcomes consistent with or
better than those observed in the pivotal study,” said John
Sheridan, president and CEO of Tandem Diabetes Care. “We are also
thrilled to see positive outcomes being presented by independent
investigators from clinical research using our automated insulin
delivery systems in pediatric populations.”
Control-IQ Hybrid Closed Loop
Technology Presentations
Control-IQ Technology in the Real World: The First 30
Days Poster Presentation (95-LB) Category: 12-D Clinical
Therapeutics/New Technology—Insulin Delivery Systems
This poster reported outcomes from a retrospective analysis of
users who uploaded at least 30 days of data to the t:connect® web
application before and after initiation of Control-IQ technology as
of March 11, 2020 and had at least 75 percent continuous glucose
monitoring (CGM) use during this time (n=1,659). Use of Control-IQ
technology led to a 10 percent increase (p<0.001) in median
sensor Time in Range (70-180 mg/dL) to 78 percent, due to a 10
percent decrease in sensor time >180mg/dL and a 0.1 percent
decrease of sensor time <70mg/dL. Users experienced 96 percent
time in closed loop automation.
Glycemic Outcomes for People with Type 1 and Type 2 Diabetes
Using Control-IQ Technology: Real World Data from Early
Adopters Poster Presentation (126-LB) Category: 12-F Clinical
Therapeutics/New Technology—Other Therapeutic Agents
This poster reported outcomes from a retrospective analysis of
users who uploaded at least 14 days of data to the t:connect web
application before and after initiation of Control-IQ technology as
of March 11, 2020 and had at least 75 percent CGM use during this
time. People with type 1 diabetes (n=2,896) showed a 9 percent
increase in median sensor Time in Range (p<0.001), and a 0.04
percent decrease in sensor time <70 mg/dL (<0.001). Users
with type 2 diabetes (n=144) experienced a 6 percent increase in
median sensor Time in Range (p<0.001). Median time spent <70
mg/dL remained unchanged (0.2 percent). Both groups experienced 96
percent time in closed loop automation.
Upcoming Basal-IQ Predictive Low
Glucose Suspend Technology Presentation
Reduction in Self-Reported Adverse Events Related to Severe
Hypoglycemia in Individuals Using A Predictive Low Glucose System:
Results from a Real-World Setting Oral Presentation (267-OR)
Session: Hypoglycemia – Guts and Garters Monday, June 15, 2020 at
9:15 a.m. Central Time
This presentation will review reductions in self-reported
adverse events related to severe hypoglycemia, including paramedic
visits, emergency room visits and hospital admissions.
About Control-IQ Advanced Hybrid Closed Loop
Technology
The t:slim X2 insulin pump with Control-IQ technology uses
glucose values from an integrated Dexcom G6 CGM, in conjunction
with other variables such as insulin on board, to predict sensor
glucose levels 30 minutes ahead and adjust insulin delivery
accordingly1,2,3. 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. If glucose values are predicted to
be above 180 mg/dL, Control-IQ technology calculates and delivers a
correction bolus with a target of 110 mg/dL up to once an hour as
needed. Control-IQ technology also offers optional settings for
sleep and exercise that will change treatment values to better
match the different physiologic needs during these activities.
About Basal-IQ Predictive Low Glucose Suspend
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 CGM to predict and help prevent lows with
zero fingersticks1,2,3. Basal-IQ technology uses CGM values to help
reduce the frequency and duration of low-glucose events by
predicting glucose levels 30 minutes ahead and suspending insulin
if they are expected to drop below 80 mg/dL or if a CGM reading
falls below 70 mg/dL. Insulin delivery resumes as soon as sensor
glucose values begin to rise.
Important Safety Information:
RX ONLY. The t:slim X2 pump, the t:slim X2 pump with Basal-IQ
technology, and Control-IQ technology are intended for single
patient use. The t:slim X2 pump, the t:slim X2 pump with Basal-IQ
technology, 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 pump
is indicated for use in individuals 6 years of age and greater.
t:slim X2 insulin pump with Basal-IQ
technology: When used with a compatible integrated
continuous glucose monitor (iCGM, sold separately), the t:slim X2
insulin pump with Basal-IQ technology can be used to suspend
insulin delivery based on CGM sensor readings. The t:slim X2 pump
with Basal-IQ technology is indicated for use in individuals 6
years of age and greater. Control-IQ
technology: Control-IQ technology is intended for use with
an 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 14 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 and the t:slim X2 pump with Basal-IQ
technology are not indicated for use in pregnant women, people on
dialysis, or critically ill patients. Users of the t:slim X2 pump,
the t:slim X2 pump with Basal-IQ technology, and Control-IQ
technology must: be able and willing 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
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. For
additional important safety information, visit
tandemdiabetes.com/safetyinfo.
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. Tandem is based in San Diego, California.
Tandem Diabetes Care, t:connect, and Basal-IQ are registered
trademarks, 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.
________________________________
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 separately
3 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200613005006/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