Tandem Diabetes Care, Inc. Reports the Successful Completion of the First Pilot Study Using Hybrid Closed Loop System
January 08, 2018 at 09:15 am EST
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Tandem Diabetes Care, Inc. reported the successful completion of the first pilot study using a hybrid closed loop system featuring its t:slim X2 Insulin Pump with embedded algorithms from TypeZero Technologies and integration with Dexcom G6 Continuous Glucose Monitoring (CGM). This pilot study was the first of three in the National Institute of Health (NIH)-funded International Diabetes Closed Loop (IDCL) Trial using the t:slim X2 Pump running the algorithm directly on the pump. The second study is now moving forward with enrollment at seven clinical sites and is anticipated to begin in the first quarter of 2018. The IDCL Trial is expected to conclude with a pivotal study in 2018, and Tandem plans to use this data in a PMA submission to the U.S. Food and Drug Administration. The hybrid closed loop system predicts high and low blood sugar levels and adjusts insulin delivery accordingly throughout the day, while still allowing the user to manually bolus for meals. In addition to basal insulin adjustments, the system also automates correction boluses. The hybrid closed loop software developed by TypeZero includes a series of algorithms developed from initial research conducted at the University of Virginia. To date, this technology has been used in more than 30 clinical studies involving more than 450 participants, with data referenced in a number of journal articles.
Tandem Diabetes Care, Inc. is a global insulin delivery and diabetes technology company, which manufactures and sells advanced automated insulin delivery systems. Its pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Its t:slim X2 and Tandem Mobi pumps can be used with a variety of infusion sets to offer patients choice in how and where their pump is worn. In addition, they are software updatable from a personal computer and compatible with its Web-based data management application. Both pumps feature its Control-IQ advanced hybrid closed loop technology, with an automated insulin delivery (AID) feature designed to help increase a user's time in targeted glycemic range. There are two primary therapies used by people with insulin-dependent diabetes, Multiple Daily Injection (MDI) and insulin pumps. As part of it AID systems, it offers pump integration with multiple CGM sensors.