2013-06-24 15:03:02 -
Study Marks Critical Milestone Toward Commercialization of a Third-Generation
Artificial Pancreas System for People with Diabetes
MINNEAPOLIS - June 24, 2013 - Medtronic, Inc. (NYSE:MDT) today announced 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, 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 breakthrough fault detection
technology, which will be critical to the commercialization of a safe and
"For people with diabetes, controlling blood sugars through the night can be
frustrating. 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," said Timothy Bailey, M.D., director
of AMCR Institute. "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 - classified by the FDA as a Control-To-Target system - is a fully
automated system that requires no interaction from the user (except for
calibration of the continuous glucose monitoring system). Going a step beyond
systems that only manage blood glucose to a broad target range, this system
automatically adjusts 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 in-clinic study will test
the system's breakthrough 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."
Additional trial details, including enrollment information, can be found at
The U.S. Overnight Closed Loop 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 be beginning in California.
To date, Medtronic's breakthroughs in diabetes technology include:
* The first integrated insulin pump and continuous glucose monitoring system,
the foundation upon which artificial pancreas technologies are built. (2006)
* The first system to automatically suspend insulin delivery based on pre-set
threshold sensor glucose values, which is commercially available in over 50
countries around the world and currently undergoing review with the FDA.
* A second-generation artificial pancreas system that automatically suspends
insulin delivery when glucose values are predicted to reach a low threshold
and then resumes insulin delivery once those glucose levels recover, a
product nearing commercialization in Europe.
About the Diabetes Business at Medtronic
The Diabetes business at Medtronic (www.medtronicdiabetes.com) is the world
leader in advanced diabetes management solutions, including integrated diabetes
management systems, insulin pump therapy, continuous glucose monitoring systems
and therapy management software, as well as world-class, 24/7 expert consumer
and professional service and support.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health and extending
life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
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Source: Medtronic, Inc. via Thomson Reuters ONE