Have you ever had pump/pod infusion failures without alerts until you figure it out with rapidly rising BGs????? Do you think there should be a better early warning system? Did you know that the amount of insulin delivered by a pump is a captured dataset?
Why aren’t there better and faster early warning alerts? I’m guessing that the FDA focuses on over-delivery which can kill a T1D and less interest in the under-delivery which only results in high BGs.
Our guests on Loop and Learn T1D Speaker series, from Diatech Diabetes, are working on an early infusion set failure alert! We’ll be working with them to share some of our NS screenshots when we’ve had failures. This really is a great example of #WeAreNotWaiting.
Diatec Diabetes, based in Memphis, TN, is developing SmartFusion: a system for insulin pumps that monitors insulin delivery for accuracy and infusion set failure. SmartFusion‘s software could be integrated into an insulin pump or app and use data from the pump, continuous glucose monitor, and patient infusion habits to monitor the success of daily insulin dosages.
THE PROBLEM: Insulin infusions are administered through subcutaneous tissue. Repeated insertions and chronic insulin exposure compromise the subcutaneous tissue under the skin. The changes in subcutaneous tissue can lead to infusion site abnormalities, which could reduce the efficacy of the insulin being used and lead to hazardous consequences to those living with this diabetes.
THE SOLUTION: SmartFusion: a system for insulin pumps that monitors insulin delivery for accuracy and infusion set failure The management team includes John Wilcox, CEO and T1D, Luis Blanco, CTO, JC Gray, CSO, and Nick Cooper COO, who all met at Florida State University Advisors include Dr. Rayhan Lal (Stanford endocrinology & T1D) and Dave Walton (T1D Exchange and T1D)
Diatech Diabetes‘ tag line: “Insulin delivery done right”
If you DO have failures (infusion sets or CGM), did you know that you can and should report these to the FDA? Most of us don’t. At most, we tell the manufacturer, who merely replaces the failed device. This data is important! Here is the link to report Manufacturer And User Facility Device Experience … an FDA database called MAUDE. I’ve reported in the past … it’s simple and quick and helps to direct attention to ongoing issues that might otherwise be swept under the rug. FDA MAUDE database