A high-tech project at the Center for Diabetes Technology at UVa to turn an ordinary smart phone into an artificial pancreas that could transform the lives of people with type 1 diabetes has received a $3.4 million grant from the National Institutes of Health.
The money will fund a new network approach to artificial pancreas design using distributed computing between local and Cloud systems that will allow real-time adjustment of insulin delivery based on the individual’s needs. The grant will also fund three clinical trials at the University of Virginia and at Stanford University that will advance the project toward its final goal of offering people with type 1 diabetes – in which the body does not produce enough insulin – an automated way to monitor and regulate their blood sugar.
“This project approaches the artificial pancreas not as a single device but as a network of local and global services working seamlessly together towards the optimal control of diabetes,” said Boris Kovatchev, PhD, of the University of Virginia School of Medicine and the Center for Diabetes Technology.
The artificial pancreas was developed at the School of Medicine by a team of researchers led by Kovatchev, the director of the UVA Center for Diabetes Technology, and Patrick Keith-Hynes, PhD. The device consists of a reconfigured smart phone running advanced algorithms, linked wirelessly with a blood glucose monitor and an insulin pump, and communicating with Internet services in real time.
The system’s developers intend for it to monitor and regulate blood-sugar levels automatically, report to a remote-monitoring site and link the user with assistance via telemedicine as needed. This would save users from having to stick their fingers to check their glucose levels multiple times a day and eliminate the need for countless syringes to inject insulin manually. The physicians on the team – Bruce Buckingham, MD, of Stanford, and UVA’s Stacey Anderson, MD, and Sue Brown, MD – have tested the artificial pancreas system in successful outpatient trials in Virginia, California and in Europe.
University of Virginia Press Release
German doctors have successfully implanted insulin-producing cells in a patient with Type 1 diabetes using a specially constructed chamber system that does not require the use of immunosuppresant drugs, according to a new study.
In a paper published Monday in the journal PNAS, researchers said the islets, or clusters of cells, remained alive for 10 months and were not rejected by the 56-year-old patient’s immune system. However, the implantation offered only moderate health improvements and requires further refinement. “This approach may allow for future widespread application of cell-based therapies,” wrote lead author Dr. Barbara Ludwig of the German Center for Diabetes Research in Dresden and her colleagues.
This week I’ve started a new clinical trial at the UVA Center for Diabetes Technology in Charlottesville. It carries an impressively long scientific study name: Biobehavioral Mechanisms of Glucose Variability. Impressive, right? The purpose of the study is to investigate how blood sugar changes in response to insulin and what the body does to counter-act low and high blood sugar in people with Type 1 diabetes. The month-long study, funded by the National Institute of Health (NIH), ends with an in-patient stay at UVA where my blood sugar will be raised to 250 mg/dl and then lowered ( using additional insulin) to a hypo level less than 65 mg/dl. (Insulin Sensitivity is the term used to describe these changes in the body).
There’s also a hidden surprise in this study — testing a new piece of Continuous Glucose Monitoring ( CGM ) technology designed to work in tandem with the new Artificial Pancreas closed-loop system. But, I’m getting ahead of the story. I will post updates on my clinical trial starting this week and until the trial ends in November.
My trip to Charlottesville for Day 1 of the trial included a nice surprise for me — an American history lover and a native of Charlottesville. Prior to my Saturday morning health screening, I was allowed to spend the night at The Duke House, also known as “Sunnyside” on Barrack’s Road located on the North Grounds. The house is owned by the University of Virginia and is presently used as a guest house for participants in the Diabetes Center for Technology clinical trials.
The original section was built about 1800, as a 1 1/2-story, two room log dwelling. It was expanded and remodeled in 1858, as a Gothic Revival style dwelling after Washington Irving‘s Gothic Revival home, also called Sunnyside. The house features scroll-sawn verge boards, arched windows, exposed beam ceilings, and a fieldstone chimney with stepped weatherings and capped corbelled stacks topped with two octagonal chimney pots.
I was welcomed to The Duke House by Dr. Sue Brown and Laura Kollar, RN, for the Center for Diabetes Technology at UVA. As I settled in for sleep late at night in the charming old house — which does have all the modern amenities — I did wonder if it would be the perfect setting for the TV show ” Legend of Sleepy Hollow.” Fortunately for me, it was only the small feet of mice that could be heard running in the walls and the halls. Or maybe it was a Type 1 D searching the kitchen for a juice box?
The original house was a log cabin built in 1800s by the Alpins family and the Sunnyside property is one of the oldest in Albemarle County. It also contains the remains of the 1806 County Poor House and was purchased the The University of Virginia in 1963 — the same year my father graduated and I celebrated by second birthday — to become a part of the North Grounds expansion.
My thanks to the UVA team for letting me stay here. It was an interesting and unexpected coincidence to spend a night in The Duke House, the night before the Duke University football team played UVA at nearby Scott Stadium. Sometimes, life comes full circle and it was nice to be back spending a night in my hometown.
Next Post: My pre-clinical trial health screening at Barringer Hall, a part of the original UVA hospital and the old maternity ward — where I was born just a few years ago.
The NursingTimes reports this on Oct. 3: “Skin drug shows ‘promising’ results on type 1 diabetes,” reports BBC News.
This story is based on a small trial of alefacept in people with newly diagnosed type 1 diabetes. The immune system of people with type 1 diabetes attacks the insulin producing cells in their pancreas. Most people with type 1 diabetes have to regularly inject themselves with insulin.
Alefacept is approved for use to treat the skin condition psoriasis in the US. Researchers hoped it might help people with type 1 diabetes, because both conditions are autoimmune conditions (where the symptoms develop due to the body’s immune system ‘malfunctioning’ and attacking its own healthy tissue). Alefacept suppresses one type of immune system cell associated with the autoimmune response, and the researchers hoped that it could also stop these cells from further attacking the insulin-producing cells.
Although the drug did not improve how much insulin was produced in the two hours after a meal, people taking the drug needed lower doses of insulin than those taking placebo and experienced fewer hypoglycaemia events – where blood glucose levels drop to an abnormally low level. These results should be seen as very preliminary, with larger and longer term trials now needed to determine whether alefacept does offer any benefit for people with newly diagnosed type 1 diabetes.
The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1 diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to compare closed-loop control with or without optimization of initialization parameters related to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals and snacks.
The study consists of an evaluation of the Artificial Pancreas device system during two 24-27.5-hour closed-loop phases in an outpatient/hotel environment. Prior to the closed-loop phases, each subject will undergo a 7-day data collection period consisting of his or her usual free-living conditions along with 3 meals of known carbohydrate content. Data from the insulin pump, a continuous glucose monitoring sensor (CGM), diet and exercise records will be collected during this period. These data from this 7-day period will be analyzed in order to come up with adapted basal insulin infusion rates and bolus insulin to carbohydrate (I:C) ratios.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01929798
Contacts: Howard C Zisser, MD;
805-682-7640 ext 255
Insulin pump maker Animas has taken another step toward perfecting (and hopefully putting on sale) the first artificial pancreas. The company doesn’t call it anything that clear-cut, instead referring to the device as “a closed-loop insulin delivery system.”
Whatever you call it, the system is based on a simple concept. What if you could make your insulin pump talk to your continuous blood glucose monitor? As your blood sugar rose or fell, the pump would supply more or less insulin as needed. In real life, of course, much more work and study is required. That’s what Animas is doing-specifically studying the two devices working in concert with an algorithm that helps predict where the patient’s blood sugar is headed. And the news there is good.
The second phases of a human feasibility trial-focusing on how the system worked overnight-found that it was effective. The 20 people testing the system had blood sugars that averaged between 70 mg/dL and 180 mg/dL for 90 percent of those nighttime hours. Less than half of those trial participants had blood sugars that dipped below 70.
“Avoiding hypoglycemia during the overnight period is a primary concern for people with diabetes, so maintaining safe glucose levels during this time frame is crucial in helping to not only achieve better control, but also helps ease worry throughout the night,” said Ramakrishna Venugopalan, Animas’s director of research and development. “We are encouraged by the results of this overnight study, and we are excited to be one step closer to bringing this technology to patients.”
The results were presented last month at an American Diabetes Association meeting in Chicago. Others involved in the study were the University of California, Santa Barbara; Sansum Diabetes Research Institute; and the Center for Diabetes Technology at the University of Virginia.
The road to this point has already taken a couple of years to travel. Animas began work on the project back in 2010, and received the okay from the Food and Drug Administration to start testing in 2011. The device remains in development, and much work and study clearly remains to be done.
That being said, the artificial pancreas looks like one of the more promising treatments for type 1 diabetics currently under development. The technology to make it work-insulin pumps and continuous glucose monitors-already exists. And as shown in this early study, the algorithm linking them together shows promise, if not perfection. As always, stay tuned.
Written By Clay Wirestone
(UVA, Padova, Montpellier, Santa Barbara, Stanford, other)
Design and execute a definitive
multi‐center trial that will
establish the artificial pancreas
as viable treatment for type 1
Dr. Boris Kovatchev leads an international diabetes research team at UVA. Read more about the team and the financial supporters who are helping make it happen. A special “Thank You” to Fred and Susan Russell of The Banting Foundation.
Have Artificial Pancreas; Will Travel.
That’s the word today from Daniel Cherñavvsky, MD, CRC with the University of Virginia Health System. “Yes, we completed the trial in Santa Barbara and the following article published in Diabetesmine.com talks about it.,” Dr. Daniel tells me. “We are ready to do the trial overseas” in France and Italy next.
Yes! The AP outpatient trial was done with participants in California in April and provided more details and data. For Daniel, the next stop on the road trip is to bring the technology to his research colleagues in France and Italy. This is all building toward home trials — yes, home trials in the real world in 2014 — by PWDs ( persons with diabetes) while being closely monitored by doctors and researchers via remote technology!
Here is a brief excerpt from the Diabetesmine.com article.
“This is all very exciting! Although when you think about it, 48 hours is a pretty short timeframe to get a realistic read on any PWD’s ongoing patterns of glucose swings. I wondered how realistic the algorithm patterns were…
“We’re just dipping our toes in the stream right now,” Dr. Howard Zisser said. “We’re going with our ‘best guess’ until we can do week-long studies.” Meanwhile, patient Jim wasn’t complaining a bit over 48 hours of long-awaited freedom. “It’s soooo nice — I don’t have to do anything!” he crooned, with his eyes all a’twinkle. Dr. Zisser just grinned. “We’re learning and developing things along the way,” he said. “It’s like the space program. We’re going to the moon, and along the way we get Tang, and who knows what other innovations that come out of the process?”