In April 2013, nearly 200 scientists and clinicians from all over the world attended a conference called “Workshop on Innovation toward an Artificial Pancreas.” Among the physician researchers was David C. Klonoff, M.D., FACP, Fellow AIMBE, medical director of Mills-Peninsula’s Diabetes Research Institute.
New information on the current status of the artificial pancreas and the latest enabling technologies to advance this field was presented at the meeting. The purpose of the two-day conference was to have a multi-disciplinary discussion of advances and prospective areas of research that would accelerate the development and delivery of a wearable, automated artificial pancreas for individuals with diabetes.
Dr. Klonoff, was on the planning committee of National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) / U.S. Food and Drug Administration, and chaired a session on “New Developments in Modeling, Algorithms and Technology. He also spoke at the meeting on the topic of mHealth (mobile health), delivering health care via mobile devices such as smartphones and wearable body sensors.
“The artificial pancreas is becoming a reality,” Dr. Klonoff said. “There are many settings where this technology could be used and many levels of complexity for such devices to control blood glucose without input from patients. The safety and effectiveness of each product will need to be carefully tested and each product will need to be approved by the FDA. Systems and components currently under development both by companies and by independent investigators offer a great deal of promise for patients with diabetes,” he said.
Dr. Klonoff’s presentation covered how mobile communications devices, such as implanted or wearable sensors, smart phones, tablets, personal digital assistants and other wireless devices, are increasingly being used for health services. These devices can provide decision support and allow patients to track their health information and assist them to make some decisions.
The value of health apps is already being demonstrated; more than 40,000 mobile health applications have been developed and it has been estimated that nearly 250 million people have downloaded at least one health app.
Mills-Peninsula was the lead site on the first and recently completed United States multi-center outpatient trial of the first artificial pancreas system. Results from that study will be presented at the American Diabetes Association’s 73rd Scientific Sessions meeting in Chicago June 21-25, at McCormick Place, Chicago, Illinois.
The Mills-Peninsula Diabetes Research Institute is an internationally recognized research center which has helped to commercialize many new devices and drugs for patients with diabetes, including the first FDA approved dedicated diabetes telemedicine product.
Current studies show that uncontrolled diabetes creates intensified medical care requirements, high health care costs, and a high risk of disabling complications for diabetics. According to the NIDDK, it is expected that “physiological glucose-metabolic control provided by an artificial pancreas will reduce the incidence of acute and chronic complications and significantly improve the quality of life of the individuals affected. As a consequence, further morbidity and mortality also may be prevented.”
The Diabetes Research Institute at Mills-Peninsula is currently conducting trials on several innovative drugs and devices. People with diabetes interested in participating in a clinical trail can call 650-696-4261.
Great advances have occurred in diabetes research over the past decade, often in incremental steps, some which were taken at Mills-Peninsula’s Dorothy L. and James E. Frank Diabetes Research Institute in San Mateo, California.
“Diabetes is one of the most serious health problems of our time,” says David Klonoff, M.D., medical director of the Diabetes Research Institute (DRI) at Mills-Peninsula Health Services. “We conduct research to tackle this problem and work toward breakthroughs in care.”
Throughout 2012, the DRI conducted research studies, participated in hospital initiatives for diabetes care and performed service for Mills-Peninsula, the U.S.government, and the national and international scientific communities. In January, Dr. Klonoff compiled a summary of the DRI’s 12 grants for research conducted in 2012.
“A complex set of social, financial, behavioral and organizational hurdles can slow advances in high-quality diabetes care,” Dr. Klonoff concluded. “Despite these barriers, we are making significant advances translating our clinical research findings into medical practice.
“Last year, we worked with many novel technologies for patients with diabetes. We are particularly proud that our DRI served as the lead center for the first multicenter outpatient study of the world’s first artificial pancreas product.”
The artificial pancreas system contains a continuous glucose monitor, an insulin pump, a wireless monitor and software which controls insulin delivery. The device is intended to protect from hypoglycemic brain or heart damage by shutting off insulin delivery for two hours in case a patient has a low sugar level and does not respond to an alarm.
Mills-Peninsula’s DRI was one of only two research centers in the United States conducting a trial in outpatients of a new type of insulin delivery system. The device heats the skin which increases local blood flow and speeds up the absorption of insulin that is pumped into the body continuously through a subcutaneous catheter. Mills-Peninsula’s DRI studied adult patients and Yale-New Haven Hospital studied pediatric subjects.
Last year, the world’s only non-invasive glucose monitor was approved. It uses light reflected off skin to determine the concentration of glucose in the body. The first research studies to support regulatory approval of this product were conducted at the Mills-Peninsula DRI, and were mentioned in the regulatory submission document.
In 2012, the DRI performed a trial of a novel long-acting GLP-1 agonist drug for diabetes that is intended for once-weekly use.
The DRI helped design a protocol for a diagnostics company to assess the analytical accuracy and human factors performance of an outpatient test for self testing of Hemoglobin A1C and was the sole test site for a pivotal clinical trial of this method. This method allows patients to collect blood specimens at home and ship the specimens to a qualified testing laboratory.
Additionally, the DRI worked on therapeutic trials of four new types of insulin. One of them is an inhaled powdered insulin using a tiny delivery device to facilitate absorption from the lungs faster than liquid insulin injected into the skin. Another insulin type is an injectable liquid that is absorbed faster into the circulation than any currently approved rapid-acting insulin. The other two are time-release insulins with longer durations of activity than any currently approved long-acting insulin.
During 2012, DRI conducted three trials of a combination treatment consisting of investigational insulin to lower glucose levels between meals combined with a recently approved novel GLP-1 agonist drug to lower glucose levels after meals with once-daily use.
About the Dorothy L. and James E. Frank Diabetes Research Institute
In 2000, community donors Dorothy L. and James E. Frank gave a gift of $3 million to the Hospital Foundation and Silicon Valley Community Foundation to found the Diabetes Research Institute. Today, the Dorothy L. and James E. Frank Diabetes Research Institute is a leading Bay Area research institution dedicated to improving quality of life for people with diabetes. Researchers work with health care companies that are developing diabetes management treatments and technologies such as needle-free devices for delivering insulin; safer, more effective oral medications; and less painful, more convenient blood tests.
David C. Klonoff, M.D., FACP, medical director of the Diabetes Research Institute at Mills-Peninsula Health Services, has been elected a Fellow of the American Institute for Medical and Biological Engineering (AIMBE). He will be inducted at the Fellow Induction and Awards Ceremony at AIMBE’s 22nd annual event in February, 2013 in Washington, D.C.
Being named a Fellow is considered one of the highest honors in the biomedical engineering discipline. Fellows represent the top two percent of the medical and biological engineering community.
AIMBE Fellows are leaders in bioengineering who are working to realize the institute’s vision to provide medical and biological engineering innovation for the benefit of humanity. The AIMBE College of Fellows consists of 1,000 individuals who are the outstanding bioengineers in academia, industry and government. These leaders in the field have distinguished themselves through their contributions in research, industrial practice and/or education.
“The mission of AIMBE is to promote public policies to foster advancement in medical and biological engineering,” Dr. Klonoff said. “At the Mills-Peninsula Diabetes Research Institute, we are applying advances in medical and bioengineering to develop new products to help people with diabetes. This award will help call attention to our hospital’s efforts to develop novel engineered devices, drug delivery systems and new medications that are safe and effective in the fight against diabetes, which is the world’s greatest epidemic.”
About Dr. David Klonoff
Dr. David Klonoff founded the Dorothy L. and James E. Frank Diabetes Research Institute of Mills-Peninsula Health Services to facilitate development of new devices and drugs for people with diabetes. He is also a Clinical Professor of Medicine at the University of California, San Francisco (UCSF). Dr. Klonoff’s productivity includes 160 publications, two patents, and 86 clinical trials as principle investigator. Dr. Klonoff chaired the scientific advisory board for developing the first FDA-approved insulin patch pump and participated in development of the first FDA-approved dedicated diabetes telemedicine system, the first FDA-approved inhaled insulin, and the first three FDA-approved incretin drugs for diabetes. He is currently the lead investigator for the first-ever randomized controlled multicenter trial of the world’s first artificial pancreas product for outpatient use. Dr. Klonoff has chaired or served on 34 government grant review panels related to diabetes technology, including panels for National Institutes of Health, the Centers for Disease Control and Prevention, NASA, National Science Foundation, U.S. Army, JDRF, and the University of Michigan.
Diabetes researchers are closer than ever to creating an artificial pancreas, something that the Mills-Peninsula Diabetes Research Institute is currently working on. Nature, an international weekly journal of science news , published a story entitled “Medical devices: Managed by Machine” about this cutting-edge work in its May 16 issue.
The article reports on the promise of artificial pancreases in the management of type 1 diabetes and quotes David Klonoff, M.D., an endocrinologist and the medical director of the Diabetes Research Institute at Mills-Peninsula Health Services in San Mateo, Calif.
According to Nature, the U.S. Food and Drug Administration (FDA) identified the artificial pancreas as a top priority and, together with the U.S. National Institutes of Health (NIH), formed the Interagency Artificial Pancreas Working Group to identify and work through any clinical and scientific challenges. Meanwhile, government funding bodies in theUnited States andEurope, as well as many medical device companies, started spending tens of millions of dollars to encourage the development of an artificial pancreas.
Dr. Klonoff has been an advisor to the FDA while this agency has been developing policies for regulating this complicated device, and an advisor to the Juvenile Diabetes Research Foundation, which raises funds to support research for this technology. Dr. Klonoff was one of 150 scientists and clinicians recently asked by the NIH to contribute to the agency’s 10-year diabetes strategic planning report to identify where to allocate scientific expertise, tools, technologies and shared resources over the next decade – including aiming for the development of an artificial pancreas. Read More about Mills-Peninsula Diabetes Expert Researching,Testing Artificial Pancreas
Mills-Peninsula Health Services and UCSF Diabetes Center are co-sponsoring the annual Diabetes Symposium and Kids’ Kamp on Saturday, March, 10, 2012. The event will be held at Robertson Auditorium at UCSF Mission Bay Conference Center in San Francisco, from 9 a.m. to 3 p.m.
Parents of children with diabetes and their families are invited to attend and learn about the latest treatments, new technologies on the horizon and strategies for managing the disease. Read More about UCSF, Mills-Peninsula Co-sponsor Diabetes Symposium & Kids’ Kamp