Tandem Diabetes Care Announces Commercial Launch of t:slim X2 Insulin Pump with Basal-IQ Technology in the United States
Tandem’s Basal-IQ algorithm is designed to look 30 minutes into the future to predict where glucose levels are heading. The device suspends insulin delivery when low glucose is predicted, then automatically resumes insulin delivery once glucose levels begin to rise. In the pivotal clinical study, use of the t:slim X2 Pump with Basal-IQ Technology demonstrated a 31 percent relative reduction in time spent below 70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the feature. The system received high usability scores in the study, with 93 percent of participants indicating that the system was easy to use, and 97 percent indicating that they felt confident using the system.4
“This launch marks the achievement of our goal to offer people with
diabetes a simple-to-use automated insulin delivery feature that can
reduce time spent low without adding significant burden to the pump
therapy experience,” said
Update Instructions for In-warranty t:slim X2 Pump Users
No action is required at this time. Individual emails are being sent to
all in-warranty t:slim X2 Pump users in
Free Basal-IQ Technology Demo App
Tandem’s free t:simulator™ App lets users experience the touchscreen interface of the t:slim X2 Insulin Pump with Basal-IQ Technology directly on a mobile device. For more information and to download the app, visit http://www.tandemdiabetes.com/tsimulator.
About
For additional product and safety information, or to begin the order
process, visit www.tandemdiabetes.com/tslimX2
or call 877-801-6901, Monday – Friday
Important Safety Information
RX ONLY. 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, the Basal-IQ Technology can be
used to suspend insulin delivery based on CGM sensor readings.
Interpretation of the System results should be based on the trends and
patterns seen with several sequential readings over time. CGM also aids
in the detection of episodes of hyperglycemia and hypoglycemia,
facilitating both acute and long-term therapy adjustments. Compatible
iCGM systems are intended for single patient use and require a
prescription. 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
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 with Basal-IQ Technology and our ability to
offer the Basal-IQ software update for current t:slim X2 Pump users.
These statements are subject to numerous risks and uncertainties,
including our ability to commence commercial scale manufacturing of the
t:slim X2 with Basal-IQ Technology, our ability to launch a new system
to facilitate online training and prescription handling for existing
t:slim X2 customers upgrading their existing devices, and the risk that
we may encounter other challenges that may delay the commercial launch
of t:slim X2 with Basal-IQ Technology, 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
1 If glucose alerts and CGM readings do not match symptoms or
expectations or if taking over the recommended maximum dosage amount of
1000 mg of acetaminophen every 6 hours, use a blood glucose meter to
make diabetes treatment decisions.
2 Dexcom G6 CGM sold
separately. The Dexcom G6 CGM transmitter can only be paired with one
medical device (either a
3 A
new prescription and additional training are required for this software
update.
4 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 [published online
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Source:
Tandem Diabetes Care Contact Information:
Media: Steve
Sabicer, 714-907-6264
ssabicer@thesabicergroup.com
or
Investors:
Susan Morrison, 858-366-6900 x7005
IR@tandemdiabetes.com