The late Mayo endocrinologists Russell Wilder, M.D., and Randall Sprague, M.D., would be smiling today at the news for patients with diabetes. Much of their lives and careers were dedicated to making sure Type 1 diabetes patients received the right amount of insulin at the right time to live long, healthy lives. I'm referring to the recent study in The New England Journal of Medicine demonstrating that an artificial pancreas — a closed-loop system of insulin pump and feedback monitor — is better at keeping patients in their glycemic range than current systems. 

Mayo researchers were among those at seven institutions whose work was represented in this six-month randomized clinical trial. The conclusion is straightforward: Using a system that employs an algorithm-guided, computerized feedback loop to provide a constant and adjusted flow of insulin provides better control than a sensor-augmented pump. In other words, the artificial pancreas did a better job keeping the participants' blood sugar levels in the normal or near normal range during the time of the study. Constant measurement, feedback and adjustment of insulin volumes, including boluses of the drug when needed, happens automatically. 

"Patients with Type I diabetes will move to new technologies when they are confident that the technology is dependable and an improvement on their current reliable system," says Yogish Kudva, M.B.B.S., Mayo physician-researcher and paper co-author. "This nationwide study, supported by the National Institutes of Health, validates the value of a closed-loop system."

A cohort of 168 people participated in the study across these seven institutions:

• Barbara Davis Center for Childhood Diabetes at University of Colorado Anschutz Medical Campus
• Icahn School of Medicine at Mount Sinai
• Joslin Diabetes Center
• Mayo Clinic
• Sansum Diabetes Research Institute
• Stanford University
• University of Virginia

Of those, 112 were assigned to using the closed-loop technology and 56 were in the control group, using a regular insulin pump. The percentage of time that the closed-loop group was in the target range for blood sugar levels increased over the six months and showed a difference of 11 percentage points, compared to the control group. 

This device, still awaiting Food and Drug Administration approval, would be the second such system after the Medtronic 670G system, which has been available in the U.S. since March 2016.

Discovery's Edge reported on early studies on Mayo's closed-loop system in 2012, and this writer recalls a news release about findings presented at the American Diabetes Association in summer 2011. It was, as always, team science — collaborative research with Mayo and external colleagues. The mathematical modeling came from Italy and led to an artificial pancreas algorithm. 

The current study uses an algorithm pioneered by Boris Kovatchev, Ph.D., at the University of Virginia. This work mirrors the earliest days when Mayo was part of an ad hoc group of expert centers conducting early clinical trials on insulin. That group of five to seven hospitals were asked by the discoverers of the drug — Drs. Banting and McLeod of Canada — to research and publish safe dosages of insulin for varying types of patients. Much of this work was published in and just after 1923. The Mayo team was led by Dr. Wilder, who began studying children with diabetes mellitus Type 1 soon after his arrival in Rochester, Minnesota, in 1919. Over the ensuing century, four generations of Mayo researchers and a long list of collaborative publications have bridged the time when Type 1 diabetes patients rarely survived to adulthood to today's engineering advancements. 

I should explain about Dr. Sprague. As a young boy, he was one of the first patients to be saved by the introduction of insulin, which was prepared at his physician's office in Chicago from animal glands. He grew up to become an endocrinologist and researcher, and arrived at Mayo Clinic in time to be mentored by Dr. Wilder. He published his own research and commentaries in medical journals well into the 1980s. 

A search of Mayo research over the past dozen years shows just under 900 articles on diabetes of some type, nearly 70 in this year alone. The research continues at the molecular and cellular levels; in transplant and regeneration of pancreatic tissue; as well as ongoing clinical studies, including related conditions, such as obesity and metabolic syndrome. 

— Bob Nellis, December 2019

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The pancreas is the organ responsible for producing insulin in the body. But, with Type 1 diabetes, the pancreas is unable to produce insulin. So patients are forced to constantly check their glucose levels and inject insulin throughout the day to maintain normal levels. It can be a demanding and painful process.

Mayo Clinic endocrinologist Dr. Yogish Kudva oversees research on artificial pancreas systems at Mayo Clinic. He says the systems can drastically improve quality of life in patients with Type 1 diabetes.

"What it does is it makes that whole process less burdensome," Dr. Kudva says.

The artificial pancreas is a two part system that automates the process and makes insulin injections more prompt and accurate.

First, a probe that's implanted below the skin constantly measures glucose levels. The probe sends a wireless signal to an insulin pump, which connects to an injection site via tubes. As the pump receives signals from the probe, it automatically injects the correct amount of insulin.

Dr. Kudva says the system has limitations, but he says ongoing research should lead to big advances and more options for patients soon.

"For example, the continuous glucose monitoring system could last for longer," he says. The continuous glucose monitoring system could get more accurate. The insulin pump itself could get smaller, ... and the tubing could get better and less intrusive."

Those advances will lead to fewer patients having to poke themselves with needles every day and a better overall quality of life.

The post Mayo Clinic Minute: Advancing technology making Type 1 diabetes management easier appeared first on Mayo Clinic News Network.

Clinical trials have allowed doctors to breathe easier about artificial pancreas cybersecurity

Imagine a computer hacker able to hijack a human body and disrupt the meticulous order of automatic bodily functions.

The idea sounds more like a science fiction story than a real life possibility. However, recent advancements in biomedical engineering led Mayo Clinic researchers Derek O’Keefe, M.B., B.Ch., B.A.O., Ph.D., Ananada Basu, M.D., and Yogish Kudva, M.D., to worry about previously unexplored complications that arise with medical technologies.

Mayo Clinic is collaborating with the University of Virginia, the William Sansum Diabetes Center, the University of California – Santa Barbara, and the University of Padua in Italy in developing an artificial pancreas to better manage type 1 diabetes. In type 1 diabetes, the pancreas produces an insufficient amount of insulin, the hormone that regulates blood sugar levels. The artificial pancreas will control patients’ blood sugar levels with less involvement from the patient, thus a form of semi-automated control.

As an electronic device, the artificial pancreas is, hypothetically, at risk for electromagnetic wave interference and wireless attacks. This susceptibility motivated a group of researchers, including Dr. Kudva, Dr. Basu, and Dr. O’Keefe, to write the article “Cybersecurity in Artificial Pancreas Experiments,” which was published online in Diabetes Technology & Therapeutics. In the article, the doctors urge funding agencies, researchers, and regulators to pay more attention to the cybersecurity of medical devices, specifically the artificial pancreas, and to support security testing in clinical trials.

Currently, patients with type 1 diabetes monitor their blood sugar levels by taking blood samples several times each day and then self-injecting the proper dose of insulin. The artificial pancreas devices, however, will automatically monitor glucose levels and deliver the necessary amount of insulin below the skin of the patient. This device has potential to free diabetic patients from the inconvenience of finger pricks and self-injections. Ideally, the patient would only be responsible for supplying the pump with insulin.

The artificial pancreas is a closed-loop system, which means that communication only exists between a glucose sensor and an insulin pump. “The device itself is like a Samsung Nexus phone, but doesn’t work as a phone: it works as an artificial pancreas hub. It’s easy to carry,” says Dr. Kudva. The sensor relays glucose levels to the control device, which in turn dispenses insulin below the skin. If, however, an outside signal could send the wrong glucose data to the handheld device, the resulting incorrect dose could be dangerous and even fatal.

The U.S. Food and Drug Administration does not currently regulate the cybersecurity of medical devices. In October of 2014, the FDA called a conference on cybersecurity of medical devices, and sent out a news release that recommended manufacturers consider cybersecurity risks while designing devices.

“There is no such thing as a threat-proof medical device,” said Suzanne Schwartz, M.D., M.B.A., director of the FDA Emergency Preparedness/Operations and Medical Countermeasures, in the news release. “It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks.”

However, with two recent clinical trials involving 21 patients under their belt, the Mayo Clinic team is much more confident in the safety and dependability of the device. “My concern about sending patients home has progressively, over time, decreased,” says Dr. Kudva. The research of others has also boosted his confidence. Clinics around the world have developed artificial pancreases and completed their own clinical trials. “Patients [collectively] have had more than 580 days on the system around the world and it seems to be quite safe,” he says. Once the device receives FDA approval, Dr. Kudva says clinical providers could offer it to patients, but tracking patient use post-marketing would still be important.

The next step for the Mayo team is a third clinical trial. This time, patients will be observed for three nights, and can then take the artificial pancreas home for two weeks. Dr. Kudva says he hopes that future trials may include ‘extension periods,’ in which patients are allowed to use their devices longer than the official clinical trial periods. This trial design is being increasingly pursued. Dr. Kudva says that in the artificial pancreas clinical trials, patients are appreciative. He says, “When the control is given to a system that seems to work reasonably well, they’re really grateful.”

July 20, 2015

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Join us on Saturday, April 12, at 9 a.m. CT when we discuss the growing problem of diabetes with endocrinologist Dr. Ananda Basu.  We’ll touch on the differences between type 1 and type 2 diabetes, and discuss who’s at risk and what can be done to treat the condition, including the status on the development of an artificial pancreas.  Join us!

Myth or Matter of Fact:  Diabetics need a special diet.

Listen to this week’s Medical News Headlines: News Segment April 12, 2014 (right click MP3) 

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