Last September, Medtronic announced FDA approval of its MiniMed 530G with Enlite system (sold outside the United States as the Veo since 2009). JDRF applauded the U.S. Food and Drug Administration (FDA) for its commitment to ensuring patients in the United States can access insulin pumps that can temporarily stop insulin delivery once sensor glucose levels fall below a predetermined threshold. This approval means people with T1D will have access to technologies on par with the rest of the world. Bringing new products to people with T1D through the healthcare system is why JDRF partners with T1D-focused companies.  JDRF looks forward to working with researchers, regulators, and the private sector to accelerate the delivery of even more impactful improvements in technology to more effectively manage the disease. This was the first product approved under the FDA’s new artificial pancreas product guidelines that JDRF helped create which were finalized in November 2012 and helped jump start what had been a long-delayed process.

• Medtronic has a predictive low glucose suspend (pLGS) system under review in Europe and hopes to market it before the end of 2014; US marketing may not be far behind.  This system is called the 640G by Medtronic.
• In May, a JDRF-funded study led by Dr. Roman Hovorka at the University of Cambridge was published and showed that unsupervised use of an overnight treat-to-range artificial pancreas system for three weeks led to improved blood-glucose control through the night—and residually through the next day too—in 16 adolescent participants with T1D, ages 12-18. The system automates insulin delivery by increasing or decreasing the insulin infusion based on monitoring of glucose levels every 12 minutes. The average nighttime blood-glucose levels of the participants remained in the target, safe range for 70 percent of the nights when the system was used, compared to 52 percent of the nights when the system was not used. Furthermore, the number of nights with hypoglycemia decreased by nearly 50 percent. Hypoglycemia, or extreme low blood sugar, is a dangerous yet common occurrence for people with the T1D. The researchers concluded that unsupervised home use of the overnight artificial pancreas system in adolescents with T1D is both safe and effective. In addition to improved blood-glucose control, trial participants and their parents reported improvements in quality of life when using the system, which were outlined in a companion study. Among the benefits noted were greater peace of mind and better sleep without having to frequently monitor their blood-glucose, and more confidence in their diabetes control. Longer and more comprehensive studies could help pave the way toward bringing the first automated artificial pancreas systems to market for use overnight—when variables such as eating and exercise pose less of a challenge.
• The use of artificial pancreas systems during sleep is of high interest, because overnight hypoglycemia occurs frequently in individuals with T1D and can result in loss of consciousness, seizure, or even death. Another JDRF-supported clinical study published in May tested whether in-home overnight hypoglycemia could be safely reduced by temporarily decreasing or suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring glucose levels. Such artificial pancreas systems are referred to as predictive low glucose suspend systems (pLGS).  They represent the next level of advance over a system that simply turns off when the glucose level goes below a threshold.  Turning off before hitting such a threshold is intended to avoid the hypoglycemic event. The study found that such a pLGS artificial pancreas system when used in 15–45 year olds with T1D and frequent nocturnal hypoglycemia, can substantially reduce overnight hypoglycemia without a meaningful increase in hyperglycemia and no increase in ketoacidosis. Use of a nocturnal pLGS system has the potential to not only reduce nocturnal hypoglycemia but also to reduce fear of hypoglycemia, which can be a significant deterrent to achieving blood glucose targets.
• Following up on the successful out-patient tests of a treat-to-range, partially automated insulin delivery artificial pancreas systems, the JDRF Artificial Pancreas Consortium is poised to launch the next step in the evaluation process.  Under the leadership of Dr. Kovatchev at the University of Virginia, the first shorter feasibility trial, followed by the longer definitive trial will test the system in a large, international, multi-site randomized study.  This at-home and unsupervised study will test how successful this system is at helping people with T1D maintain ideal blood-sugar levels as they go about their normal routine.  The first phase of the study is scheduled to begin in the second half of 2014.