artificial pancreas for diabetes sufferers waiting for FDA approval

Artificial Pancreas Awaits FDA Approval: Offers Hope For Diabetes Sufferers [Video]

According to Newsweek, an artificial pancreas that is awaiting approval from the U.S. Food and Drug Administration (FDA) could help those who suffer from diabetes by monitoring their blood sugar levels. The artificial pancreas would help diabetes sufferers by delivering insulin to prevent hypoglycemic attacks. The MiniMed 640G, which is developed by the Dublin-based firm Medtronic, combines a glucose sensor with an insulin pump that is connected to a patch that delivers insulin into the body. The device works with a display the size of a smartphone that provides information to diabetes sufferers who wear the “artificial pancreas.”

The device, which is already being used in several countries, was used in a trial at the beginning of 2015, and Medtronic submitted an application to the FDA based on results of trials that were conducted on 124 patients. Pratik Choudhary, a senior lecturer and diabetes consultant at King’s College in London, said at the beginning of the trial that they wanted to minimize the impact of hypoglycemia and make the lives of diabetes sufferers better. Pratik stated that patients in their user evaluation “really loved MiniMed 640G…because it effectively and unobtrusively reduced hypoglycemia.”

The artificial pancreas was also mentioned in an article by Newsmax that mentioned diabetes sufferers wearing the device would have to re-calibrate the device with a finger prick reading every 12 hours. The glucose sensor in the artificial pancreas also would need to be changed every seven days, and the insulin pump would have to be refilled every three days, according to Bloomberg. The Bloomberg article says that this new artificial pancreas would be the first device that would allow diabetes sufferers to turn over a “part of their daily routine to a machine.” The device measures blood sugar levels every five minutes and automatically adjusts the delivery of “micro-doses of insulin” to keep sufferers of diabetes within their target range.

Richard Bergenstal, executive director of the center in Minneapolis that led the trial, Park Nicollet’s International Diabetes Center, told Bloomberg that the device would help diabetes sufferers by not having to worry about their diabetes.

“We want them to get control without spending every hour of the day worrying about their diabetes or preparing for the next event.”

According to Newsmax, a Medtronic statement described the MiniMed 640G system as a “simple user interface, full-color screen, waterproofing, and remote bolus.” In the statement by Medtronic, Satish Garg, M.D., professor of pediatrics and medicine and the director of the adult diabetes program at the University of Colorado Barbara Davis Center for Childhood Diabetes, said, “Insulin pumps and continuous glucose monitoring systems have greatly improved the ability for people with diabetes to achieve better glucose control and live longer, healthier lives.”

“However, even with these systems, patients must make hundreds of decisions each day. Simplifying this self-management with a more automated Hybrid Closed Loop system would have a very meaningful impact on these patients’ lives.”

The Hybrid Closed Loop system of the artificial pancreas is designed to control glucose levels 24 hours a day. People using the system only have to enter their carbohydrates at mealtime and perform the calibration, along with the minimal maintenance tasks as mentioned before. Medtronic will enroll up to 150 patients with type 1 diabetes between the ages of 14 through 75 on the new pump therapy. Francine Kaufman, M.D., Chief Medical Officer and Vice President of Global Medical, Clinical & Health Affairs at Medtronic Diabetes said that the closed loop system is a result of years of research.

“After years of research and development, the critical components of a closed loop system are here. We are thrilled to be partnering with the world’s leading investigators to do the clinical work to bring this technology to market so that it can help people with diabetes enjoy even greater freedom and better health.”

[Photo by Alan Rosenberg/Feature Photo Service for IBM]

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