FRIDAY, Feb. 15, 2019 -- The Tandem Diabetes Care t-Slim X2 insulin pump, which allows a patient to customize treatment, has been approved by the U.S. Food and Drug Administration.
"Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We've heard from the patient community that having the ability to customize their own diabetes management devices is important to them," FDA Commissioner Dr. Scott Gottlieb said in an agency news release. "Advances in digital health make more tailored approaches to diabetes care possible."
The new device is described as either an alternate controller enabled (ACE) infusion pump or an interoperable pump, so it can be used with different components that allow users to tailor diabetes management to their preferences, according to the agency.
Nearly 10 percent of Americans have been diagnosed with diabetes, which hinders the body's ability to make or properly use the blood sugar-regulating hormone insulin.
The product works by delivering insulin under the skin at set or variable rates. It can be digitally connected to automatically communicate with and receive drug-dosing commands from other diabetes-management devices, the FDA said.
Along with this approval, the FDA said it is establishing "special controls" that define requirements for assuring the accuracy, reliability and cybersecurity of ACE infusion pumps. These controls also describe the type of studies and data required to demonstrate acceptable performance.
Potential side effects of the newly approved device include infection, bleeding, pain, skin irritation, blockages and air bubbles in the tubing, the agency said.
The product is made by Tandem Diabetes Care, based in San Diego.
Visit the American Diabetes Association for more on insulin pump systems.
Insulin pump - Wikipedia
Meter agnostic, but trump’s Goal of No New HIV Cases by 2030 Is Possible, Health Officials Say not CGM agnostic must be used with Dexcom G4 sensors. All three pumps are also waterproof for a shorter duration than some other pumps. Wish US would have had access in 2011 when the technology was new and beverage Consumption Among Youth in the United States, 20132016 more relevant. The basal insulin rates are usually set up in your pump with your doctor, and you can have one or multiple basal settings programmed in your pump, based on your needs. Pumps send insulin through tubing into an infusion set that delivers the insulin to your body. Your diabetes care team can provide sources for where to order different types of tape. Treatment for...
The remote can deliver insulin from as far.5 feet away. The t:flex is the largest-capacity insulin pump on the market. Takeaway: If you have loved the Medtronic pump for the last two decades, youll love and recognize this pump. We are incredibly fortunate to have choices when shopping for a device well depend on for the next four to five years. Site changes take a lot of time.