FDA Approves t:flex™ Large Capacity Insulin Pump for Diabetes Treatment

Comments by: Patti Urbanski, MEd, RD, LD, CDE

The t:flex™ Insulin Pump was approved for marketing by the U.S. Food and Drug Administration, making it the largest-capacity insulin pump available in the United States. The pump is manufactured by Tandem Diabetes Care.

“The t:flex pump makes insulin pump therapy a better option for those people who are insulin resistant and require large amounts of insulin,” said Patti Urbanski, MEd, RD, LD, CDE, Diabetes Educator and Clinical Dietitian, St. Luke’s Hospital, Duluth, MN.  “This means insulin pump therapy is now an option for many patients who would not have been ideal candidates for this type of therapy in the past,” said Ms. Urbanski, who also is a member of the Tandem Diabetes Care clinical advisory board.

Pump has 480-unit Capacity and Delivers Microboluses of Insulin
The pump has a reservoir capacity of 480 units and delivers insulin in microboluses using the proprietary Micro-Delivery technology. This technology allows for the delivery of insulin in doses as small as 0.001 u/hr, at rates above 0.1 u/hr.

Market research conducted by Tandem Diabetes Care found that two-thirds of endocrinologists cited limited capacity as the number one barrier to insulin pump adoption for people with type 2 diabetes who are insulin dependent. Thus, the manufacturer designed the pump to offer a larger capacity, while maintaining a smaller size than other larger pumps on the market. The t:flex design is similar to the company’s t:slim® Insulin Pump, and has touch screen technology similar to that used in smart phone interfaces.

Ideal Candidates for the t:flex Insulin Pump
Ideal candidates for the t:flex pump include “those who require both long-acting, basal insulin as well as mealtime insulin who are also insulin resistant and require more than 100 units of insulin per day,” said Ms. Urbanski. “Appropriate candidates must be willing to learn pump therapy and be willing to do enough blood glucose testing to determine their needed basal rates and mealtime insulin doses,” Ms. Uranski said.

The t:flex pump can be used with the t:connect computer application, which uploads and displays data from the insulin pump as well as blood glucose meters to help patients and health care providers detect trends in insulin use and further fine-tune therapy.

May 1, 2015

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