SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced publication of real-world data from more than 8,000 users of the t:slim X2™ insulin pump with Basal-IQ® predictive low-glucose suspend technology in the medical journal Diabetes Technology and Therapeutics. The results demonstrate sustained reductions in hypoglycemia across all groups using Basal-IQ technology, regardless of prior therapy. A specific sub-analysis of t:slim X2 pump users who remotely updated their pump software to Basal-IQ technology revealed a 45 percent relative risk reduction in hypoglycemia and a 71 percent relative risk reduction of hypoglycemic events. The reductions in hypoglycemic outcomes with real-world use exceeded reductions observed in the controlled pivotal study for Basal-IQ technology.
“This data supports the overwhelmingly positive feedback we hear from our customers using Basal-IQ technology and the clinical improvement people often report experiencing after initiating its use,” said John Sheridan, president and CEO of Tandem Diabetes Care. “We continue to hear that our t:slim X2 insulin pump with Basal-IQ technology is extremely simple to learn and use, which is a core tenet across all of our products, and we believe this leads to greater customer satisfaction and improved clinical outcomes.”
Summary of Hypoglycemia Data Published in Diabetes Technology and Therapeutics1
A retrospective analysis was conducted using deidentified data from the t:connect® diabetes management application. The analysis included data from patients ages 6 and up who had used Basal-IQ technology for at least 21 days between August 31, 2018 and March 14, 2019 (N = 8,123). Two sub-analyses were also conducted. The first looked at people who used a t:slim X2 insulin pump with continuous glucose monitoring (CGM) integration for 21 days prior to starting Basal-IQ technology (n = 1,371). The second included people who had at least nine weeks of Basal-IQ technology use regardless of prior therapy or insulin pump experience (n = 3,563).
Use of the t:slim X2 insulin pump with Basal-IQ technology led to an immediate and sustained reduction in hypoglycemic events. In the sub-analysis of people who used a CGM-enabled t:slim X2 pump prior to initiation of Basal-IQ technology, introduction of the feature reduced the mean time spent below 70 mg/dL from 3.0 percent to 1.76 percent, which represents a 45 percent relative risk reduction of hypoglycemia. The sub-analysis of those with nine weeks of Basal-IQ technology use showed that mean time spent below 70 mg/dL decreased sharply on the first day of use and remained low (1.74 percent) over time. Other outcome measures included time in range, mean glucose, hyperglycemia, and total daily dose.
Muller L, Habif S, Leas S, Aronoff-Spencer E. Reducing Hypoglycemia in the Real World: A Retrospective Analysis of Predictive Low-Glucose Suspend Technology in an Ambulatory Insulin-Dependent Cohort. Diab Technol Ther. 2019;21(9):474-484. DOI: 10.1089/dia.2019.0190
Link to full article (open access): https://www.liebertpub.com/doi/10.1089/dia.2019.0190
About the t:slim X2 Insulin Pump with Basal-IQ 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 continuous glucose monitor to predict and help prevent lows with zero fingersticks*. The t:slim X2 pump includes advanced features like a large color touchscreen, rechargeable battery, Bluetooth® wireless technology, USB connectivity and watertight construction (IPX7)2. It is capable of remote software updates using a personal computer, offering the potential for in-warranty users to access new features as they meet necessary regulatory requirements3. The t:slim X2 pump is up to 38 percent smaller than other insulin pumps and holds up to 300 units of insulin.4
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.
Free t:slim X2 Pump Software Updates Through End of 2020
Tandem is the only company that offers remote software updates for its insulin pumps as new features are approved by the U.S. Food and Drug Administration (FDA). All software updates approved by the FDA through the end of 2020 will be offered for no cost through the Tandem Device Updater for in-warranty customers who purchase a pump prior to December 31, 2020, including current customers5.
For additional product and safety information, or to begin the order process, visit www.tandemdiabetes.com/tslimX2
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. Tandem 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 Basal-IQ technology, which features integrated continuous glucose monitoring and remote software updates. Tandem is based in San Diego, California.
Tandem Diabetes Care, Basal-IQ and t:connect are registered trademarks, and t:slim X2 and t:simulator are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc. All other trademarks 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 ability of the t:slim X2 pump to provide remote feature updates, the timing and outcome of regulatory approvals for new product features and updates, and the ability of our products to improve customer satisfaction and clinical outcomes. These statements are subject to numerous risks and uncertainties, including the risks that technical problems may prevent or delay remote software updates, regulatory agencies may fail to approve new product features or updates on our expected timeframe or at all, and the level of customer satisfaction from the use of our products and features may be different from what we expect, as well as other risks identified in Tandem’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, respectively, and other documents 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.
* 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.
1 DTT reference
2 Tested to a depth of 3 feet for 30 minutes
3 Additional feature updates are not currently available for the t:slim X2 pump with Basal-IQ technology and are subject to future FDA approvals. A prescription and additional training may be required to access certain future software updates.
4 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.
5 Additional feature updates are not currently available for the t:slim X2 pump with Basal-IQ technology and are subject to future FDA approvals. A prescription and additional training may be required to access certain future software updates. Offer only available to customers who reside in the United States, who are in warranty at the time they update their pump and who purchased a t:slim X2 insulin pump on or before December 31, 2020. Tandem may discontinue select software and features over time at its discretion. This is a limited time offer and Tandem reserves the right to discontinue this program at its discretion.