06.24.13
Minneapolis, Minn.-based medical device giant Medtronic Inc. has begun the first patient enrollments in the U.S. Overnight Closed Loop Study, a key feasibility trial to begin the commercialization path for a third-generation, fully automated artificial pancreas system for people with diabetes. Under an investigational device exemption granted by the U.S. Food and Drug Administration (FDA), the study will examine a closed-loop algorithm that is designed to automatically achieve a specified target glucose value throughout the night. The in-clinic study will also test Medtronic’s fault detection technology, which be critical for the device’s safety and future approval and sales.
“For people with diabetes, controlling blood sugars through the night can be frustrating,” said Timothy Bailey, M.D., director of Advanced Metabolic Care & Research Institute. “Too much insulin can cause the blood sugar to go too low. Not enough insulin will result in waking up with blood sugar too high, making the next day’s diabetes management challenging. Technology that safely and automatically adjusts insulin delivery overnight would allow people with diabetes to wake up with normal blood sugars. This in turn could improve overall diabetes control with less anxiety, significantly improving the daily lives of people with diabetes. This is why the findings from this trial will be so important.”
This system, which is classified by the FDA as a control-to-target system, is fully automated and requires no interaction from the user (except for calibration of the continuous glucose monitoring system). The system also is designed to automatically adjust insulin delivery to achieve a specific glucose value, such as 120 mg/dL.
Up to 85 subjects will be enrolled at six investigational centers in the United States. Overnight in the clinic, trial participants will use Medtronic’s closed loop, artificial pancreas system consisting of a MiniMed insulin pump, continuous glucose monitor and an Android phone. The study will test the system’s fault detection technology by simulating system failures and examining the algorithm’s ability to prevent the over- or under-delivery of insulin in even the most unlikely circumstances.
“For more than a decade, Medtronic has been conducting clinical research of artificial pancreas systems, working toward bringing to market systems that think, act and communicate through cutting-edge automation and connectivity to help patients spend less time worrying about and managing their diabetes and more time living,” said Francine Kaufman, chief medical officer and vice president of global clinical affairs for Medtronic Diabetes. “The safety and reliability of these artificial pancreas technologies is absolutely critical. This study is the first to put closed loop algorithms to the test, simulating the ‘worst case’ scenarios to ensure patient safety should a fault occur.”
This study is the latest in Medtronic’s 10-year history of clinical trials that examine different elements of the closed-loop algorithms to evaluate both safety and efficacy. Additional overnight closed-loop studies using Medtronic’s algorithm are currently underway in Australia and the United Kingdom. An evaluation of overnight closed loop in a diabetes camp setting will begin in California.
“For people with diabetes, controlling blood sugars through the night can be frustrating,” said Timothy Bailey, M.D., director of Advanced Metabolic Care & Research Institute. “Too much insulin can cause the blood sugar to go too low. Not enough insulin will result in waking up with blood sugar too high, making the next day’s diabetes management challenging. Technology that safely and automatically adjusts insulin delivery overnight would allow people with diabetes to wake up with normal blood sugars. This in turn could improve overall diabetes control with less anxiety, significantly improving the daily lives of people with diabetes. This is why the findings from this trial will be so important.”
This system, which is classified by the FDA as a control-to-target system, is fully automated and requires no interaction from the user (except for calibration of the continuous glucose monitoring system). The system also is designed to automatically adjust insulin delivery to achieve a specific glucose value, such as 120 mg/dL.
Up to 85 subjects will be enrolled at six investigational centers in the United States. Overnight in the clinic, trial participants will use Medtronic’s closed loop, artificial pancreas system consisting of a MiniMed insulin pump, continuous glucose monitor and an Android phone. The study will test the system’s fault detection technology by simulating system failures and examining the algorithm’s ability to prevent the over- or under-delivery of insulin in even the most unlikely circumstances.
“For more than a decade, Medtronic has been conducting clinical research of artificial pancreas systems, working toward bringing to market systems that think, act and communicate through cutting-edge automation and connectivity to help patients spend less time worrying about and managing their diabetes and more time living,” said Francine Kaufman, chief medical officer and vice president of global clinical affairs for Medtronic Diabetes. “The safety and reliability of these artificial pancreas technologies is absolutely critical. This study is the first to put closed loop algorithms to the test, simulating the ‘worst case’ scenarios to ensure patient safety should a fault occur.”
This study is the latest in Medtronic’s 10-year history of clinical trials that examine different elements of the closed-loop algorithms to evaluate both safety and efficacy. Additional overnight closed-loop studies using Medtronic’s algorithm are currently underway in Australia and the United Kingdom. An evaluation of overnight closed loop in a diabetes camp setting will begin in California.