Tandem Diabetes Care t:Slim X2 insulin pump got FDA approval for marketing. It comes with interoperable technology to deliver insulin through skin for adults and infant at set or variable rates for diabetes mellitus patients. It has Basal-IQ™ Technology helps reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to drop below 80 mg/dL.
It is Alternate Controller Enabled (ACE) infusion pump which can be used with different components for diabetic therapy management. It helps doctor and patient to tailor made their solution for diabetic problems. It can be connected digitally to other devices in order to receive automatic drug dosing commands such as AID system or t:Slim X2 pump. It can dose insulin accurately and reliably and at the rates and volumes programmed by the user.
It is a smallest available pump comes with large color touchscreen, rechargeable battery, Bluetooth, water tight construction, and updatable software. It can be integrated with any continuous glucose monitoring devices like Dexcom G6 CGM System.
The number of patients having diabetes have risen from 108 million in 1980 to 423 million in 2014 with an increase of 8.5% in 2014 for the age above 18 years of adult. In USA, around 100 million suffer from this disease and India has around 31.7 million patients and it may rise to 80 million by 2030.
The disease require continuous monitoring, such development in healthcare technology will eventually helps patients to use devices as per their preferences and requirement. As it is intended for interoperable use to aid patient who seek more customize treatment which also open new doors of innovation for companies to explore more compatible and preferable devices for patients.
As it is first interoperable device approved by FDA reviewed through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices (Class II) of a new type. But future ACE device will move through 510(K) process. Other insulin pumps are generally cleared as standalone devices (Class II) or as part of a single, predefined diabetes management system (Class III).
FDA is also coming up with new regulatory criteria called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance, type of studies and data required to demonstrate acceptable pump performance of ACE infusion pumps. It will provide safety and effectiveness of future products.
Risk related to use the t:Slim X2 insulin pump is similar to other devices and can cause bleeding, pain, infection or skin irritations, blockages and air bubbles in the tubing or incorrect drug delivery include low blood glucose (hypoglycemia), high blood glucose (hyperglycemia) and a dangerous rate of fat metabolization that may make the blood slightly acidic (diabetic ketoacidosis). It is not approved for use in pregnant women, persons on dialysis, or critically ill patients.
