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Data Presented at ATTD 2017 Demonstrate Clinical Advantages of Tandem Diabetes Care Sensor-augmented Pump (SAP) over Medtronic MiniMed SAPs

Mittwoch, 15.02.2017 19:05



SAN DIEGO --(BUSINESS WIRE)--

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today presented study results comparing retrospective user data from sensor-augmented pumps (SAPs) made by Tandem Diabetes Care and Medtronic Minimed®. SAPs receive continuous glucose monitoring (CGM) data from a wearable sensor. The Tandem SAP demonstrated statistically significant clinical advantages, including reduced hypoglycemia, increased time in range, and improved overall glycemic control, despite approximately half of Medtronic SAP users actively using a feature that suspends insulin delivery if blood glucose falls below a preset threshold. These data were presented during a poster session at the 10th Annual Advanced Technologies and Treatments for Diabetes (ATTD) International Conference in Paris, France.

“This study suggests that our simple-to-use touchscreen interface may translate to improved clinical outcomes for people with diabetes," said Betsy Dokken, PhD, Director of Clinical Affairs at Tandem Diabetes Care. "The data reinforces our assertion that not every insulin pump delivers the same benefits, and that choice in therapy options is important for the diabetes community.”

A retrospective study was conducted in which de-identified Tandem SAP user data from the period of October 2015 – August 2016 were collected from the t:connect® Diabetes Management Application for analysis (n=3,046). These findings were compared to similar data collected from the CareLink® Therapy Management System between September 2011 and October 2013.1 Both the Tandem and the Medtronic data sets utilized the same inclusion criteria: people with type 1 and type 2 diabetes using a SAP, at least 6 months of sensor use, and more than 15 days of CGM use during the first 6 months. Compared with Medtronic SAP user results, those using the Tandem SAP demonstrated:

  • Reduced Hypoglycemia - Tandem SAP users showed reduced time in each of the hypoglycemic ranges. The effect size is large and persists regardless of the frequency of sensor usage.
  • Increased Time in Range - Tandem SAP users who utilized the sensor at least 25% of the time showed increased time in range relative to Medtronic SAP users with the same sensor usage time.
  • Improved Overall Glycemic Control - The Tandem SAP demonstrated improved control across all glycemic ranges for subjects using the sensor at least 75% of the time. These users spent less time both hypoglycemic and hyperglycemic when compared to users of the Medtronic SAPs.

Based on earlier data demonstrating a greater ease-of-use and lower rate of error for the t:slim® Insulin Pump2, the current results may be related to the usability benefits introduced by the touchscreen, suggesting that the intuitive user interface of the Tandem SAP translates into better outcomes in everyday life.

In a second poster presentation, data were presented from a study demonstrating a reduced risk of hypoglycemia associated with Tandem pump use compared to previous methods of diabetes therapy. Data were collected from patients with either type 1 (90%) or type 2 (10%) diabetes who had been using a Tandem pump for at least 1 year (N = 1,370). Participants voluntarily filled out an online survey with questions about the occurrence of mild hypoglycemic events (able to treat the low themselves), medium hypoglycemic events (needed assistance from someone but did not need to go to the hospital) and severe hypoglycemic events (needed assistance from a medical professional and/or needed to go the hospital). Questions focused on both the year before starting a Tandem pump (using previous method of diabetes therapy) and the past year using their Tandem pump. Results demonstrated that, even when controlling for CGM usage, Tandem pump users reported a 52% reduction in severe hypoglycemia, a 31% reduction in medium hypoglycemia, and a 15% reduction in mild hypoglycemia, compared to previous methods of diabetes therapy. Furthermore, there was a statistically significant reduction in ambulance rides due to severe hypoglycemia of 58% and in days spent at the hospital due to severe hypoglycemia of 50%.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with diabetes who use insulin. The Company manufactures and sells the t:slim X2™ Insulin Pump, the slimmest and smallest durable insulin pump currently on the market, the t:flex® Insulin Pump, the first pump designed for people with greater insulin requirements, and the t:slim G4™ Insulin Pump, the first continuous glucose monitoring-enabled pump with touchscreen simplicity. Tandem is based in San Diego, California.

Any forward-looking statements are subject to risks and uncertainties including those identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as other documents that the Company files with the Securities and Exchange Commission. Actual results may differ materially from those anticipated or projected in this release.

Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2, #tslimG4, #tflex, #tconnect, and $TNDM.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.
t:slim, t:flex and Tandem Diabetes Care are registered trademarks, and t:slim X2 and t:slim G4 are trademarks of Tandem Diabetes Care, Inc. Medtronic, Minimed and Carelink are registered trademarks of Medtronic, Inc.

1 Battelino T, Liabat S, Veeze HJ, Castañeda J, Arrieta A, Cohen O. Routine use of continuous glucose monitoring in 10 501 people with diabetes mellitus. Diabet Med. 2015;32:1568–1574.
2 Schaeffer, N. E., Parks, L. J., Verhoef, E. T., et al. Usability and training differences between two personal insulin pumps. J Diabetes Sci Technol, March 2015 vol. 9 no. 2 221-230.

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