FDA has approved an artificial pancreas system—based on technology from the University of Virginia Center for Diabetes Technology—that robotically monitors and regulates blood glucose levels.
The artificial pancreas system, known as Control-IQ and developed by Tandem Diabetes Care, monitors blood glucose levels with steady glucose monitor (Dexcom G6 CGM) and robotically delivers the hormone insulin as required.
The system frees patients from testing their blood sugar levels several times a day by fingerstick, and from the delivery of insulin by several daily injections.
The pump is programmed with an algorithm engineered at UVA that uses glucose monitoring data to adjust the recipient’s insulin dose robotically.
FDA permit follows outcomes from a multicenter medical trial published in the New England Journal of Drugs that found the brand new artificial pancreas system was more practical than present treatments at maintaining glucose levels in people with type 1 diabetes.
The research showed that the system advanced blood glucose control overnight.
During the study, 168 individuals age 14 or older with type 1 diabetes were randomly assigned to use both the artificial pancreas system or sensor-augmented pump (SAP) therapy with a steady glucose monitor and insulin pump that didn’t robotically adjust insulin all through the day.
The researchers observed that users of the artificial pancreas system significantly increased the amount of time with their glucose quantity in the target range. In contrast, the time in vary in the SAP group remained constant over six months.