This insulin pump from an American manufacturer is set to create a stir in Britain, bringing slim, simple and sophisticated options to the choice currently available. At the end of April American-based Tandem Diabetes Care, a medical device company and manufacturer of touchscreen insulin pumps announced receipt of CE mark approval for its t:slim X2 insulin pump with Dexcom G5 Mobile continuous glucose monitoring (CGM) integration.
The pump is due to become available in the UK this summer, with the company due to confirm a distribution agreement soon. The touchscreen insulin pumps have been available in the United States since 2012, having gained U.S. Food and Drug Administration (FDA) approval of the t:slim X2 insulin pump with Dexcom G5 Mobile CGM integration in August 2017.
The pump includes advanced features such as a large colour touchscreen, rechargeable battery, USB connectivity and watertight construction. It is the only pump that integrates with Dexcom G5 Mobile CGM, and the first CGM-enabled pump approved to let users make treatment decisions without needing a blood test to be done before dosing (i.e. to read from GCM alone). The t:slim X2 Pump is up to 38% smaller than many other insulin pumps and yet holds up to 300 units of insulin.
Kim Blickenstaff, President and CEO of Tandem Diabetes Care commented on gaining the CE Mark, “As our first product to receive CE mark, this milestone is key to the fulfilment of our vision to bring the features and benefits of our unique insulin pump technology to people outside of the United States. Our plans to launch the t:slim X2 Pump internationally in the second half of this year is of particular strategic importance during this time where insulin pump options are becoming increasingly limited.”
In a recent trial, the PROLOG (PLGS for Reduction Of LOw Glucose) trial, it was shown that users experienced reduced time in hypo using t:slim X2 insulin pump with predictive low glucose suspend (PLGS), called Basal-IQ technology. Data from the trial showed that the system reduced time spent in hypo compared to sensor-augmented pump (SAP) therapy alone.
The t:slim X2 with Basal-IQ technology uses Dexcom G5 Mobile CGM sensor values to suspend insulin delivery when low blood glucose is predicted. It then automatically resumes insulin delivery when glucose levels begin to rise. The trial has users on system for a 3-week period while at home (so not in a clinical environment) and reduced the number of sensor glucose readings below 3.9mmols/L by 31% compared to the control period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. Importantly, this marked reduction of time spent in low glucose was accomplished without any increase in the rate of hyperglycaemia (being too high) and therefore improved overall time in range, decreasing patients’ daily burden of diabetes as well as reducing the changes of long-term complications.
About the study Blickenstaff adds, “Reducing the risk of hypoglycaemia has been the most requested feature of automated insulin delivery in our market research, due to the severity of the complications when left untreated. The data from this study supports our mission to improve the lives of people with diabetes through new innovations.”
* The PROLOG study was a multi-centre, randomized crossover clinical trial and included 103 participants with Type 1 diabetes aged between 6 to 72 years of age at four research centres across the US and was coordinated by the Jaeb Center for Health Research in Tampa, Florida. The mean A1C of participants entering the study was 7.3%, with the majority already using a pump (83%) and/or CGM (84%). The primary endpoint of the study was to demonstrate a reduction in the percentage of CGM values below 3.9mmol/L when using Tandem’s PLGS feature.
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