Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ Technology
New Predictive Low Glucose Suspend Feature to Launch with Dexcom G6 CGM System Integration
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. Use of the t:slim X2 Pump with Basal-IQ technology in the pivotal clinical study 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.
“Hypoglycemia can be a significant source of fear for people who use
insulin and is a major cause of hospitalizations for people with
diabetes,” said Dr.
“The t:slim X2 Pump with Basal-IQ technology was designed to predict and
help prevent time spent low using best-in-class CGM technology,” said
Benefits of the New Basal-IQ Predictive Low Glucose Suspend feature:
Predicts and helps prevent lows – Using CGM values, the Basal-IQ feature looks ahead 30 minutes and suspends insulin when glucose is predicted to drop below 80 mg/dL or if glucose is currently below 70 mg/dL and falling. The system resumes insulin once glucose values start to rise.
No fingersticks – With Dexcom G6 CGM integration, the Basal-IQ feature works with no fingersticks required for mealtime dosing or calibration.1 Other benefits of the Dexcom G6 CGM include an extended 10-day wear, acetaminophen blocking5, and the ability to share real-time CGM data with up to 5 followers.6
Works silently in the background - No additional alerts or alarms are required to use Basal-IQ technology compared to standard CGM-enabled pumps. Users can choose whether or not to receive alerts when insulin is suspended and resumed based on their personal preference.
No complicated modes to manage – The Basal-IQ feature has no complicated settings to manage and operates without constant input or interaction. The user only has to decide whether they want the feature on or off.
Standard features of the t:slim X2 Insulin Pump:
Small and discreet – The t:slim X2 Pump is up to 38 percent smaller than other pumps7, yet can hold up to 300-units of insulin.
Can be used with or without the Basal-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.
#1-rated customer support – Tandem’s
For additional product and safety information, or to begin the order
process, visit www.tandemdiabetes.com/tslimX2
or call (877) 801-6901, Monday – Friday
Free Demo App – Basal-IQ Technology Coming Soon
Tandem’s free t:simulator™ App will be updated in early July to let you experience the touchscreen interface of the t:slim X2 Pump with Basal-IQ technology directly on your mobile device. For more information and to download the app, visit http://www.tandemdiabetes.com/tsimulator.
Free Software Update for Current t:slim X2 Pump Users
All in-warranty t:slim X2 Pump users in
Basal-IQ Technology – Clinical Outcomes
Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects more than
29 million people in
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 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, 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
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
4 A new prescription and additional training are required for this software update.
5 Dexcom G6 CGM readings can be used to make diabetes treatment decisions when taking up to a maximum acetaminophen dose of 1,000mg every 6 hours. Taking a higher dose may affect the G6 readings.
6 Separate Follow App required.
7 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,
8 dQ&A USA Diabetes Connections Surveys, 2013-2017
9 Buckingham B, et al. PROLOG: A Randomized Clinical Trial to Assess The Efficacy of Predictive Low Glucose Suspend Versus Sensor-Augmented Pump Therapy in The Management of Type 1 Diabetes [Session #026].
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Tandem Diabetes Care
Steve Sabicer, 714-907-6264
Susan Morrison, 858-366-6900 x7005