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
Writing a blog about living with Type 1 diabetes and promoting the need for clinical trials — is not exactly front-page cybernews. It’s OK to admit that I’m blogging for a very limited audience: Me, myself and I. We R the Cure is dedicated to finding solutions, sharing current research news, and spotlighting the need for more persons with Type 1 diabetes to participate in clinical trials.
I’m not seeking publicity or the spotlight. Participating in these studies does, however, sometimes make me feel like Steve Martin’s character in the 1984 movie, ” The Lonely Guy.” Am I the only guy doing this?
Last Thursday at dawn, I traveled to Charlottesville for my in-patient “Metabolic Challenge” hospital admission on Day 17 of the ” Behavioral Mechanisms of Glucose Variability” clinical trial at the Center for Diabetes Technology at UVA. The good news: I completed the study parameters by providing my blood to the researchers as they raised my glucose level above 250 mg/dl and then lowered it below 60 mg/dl to see how the human body responds to glucose swings. “Greater understanding of insulin sensitivity, particularly how the body counters a low blood sugar,” will help researchers and technology experts determine how to refine the math calculations or ” brain power ” needed for the Artificial Pancreas system, according to the UVa team.
So, let me give you the Top 5 newsworthy or ” BIG PICTURE” results from my in-patient day.
Number 5: I did not wear the new DexCom 5 CGM prototype for the admission as originally planned. The manufacturer was not ready to release it for human trial just yet. The next generation DexCom 5 sensor will transmit its glucose readings directly to the AP’s SmartPhone and not to CGM transmitter. This is a key step in closing the loop on the closed-loop AP.
Number 4: The DexCom 5 should be available for testing in upcoming AP clinical trials, hopefully as soon as Feb. 2014. If the DexCom 5 is tested in trials then it sets up the important next step: Setting up “AP home trials” for out patient clinical trials in 2014-2015. A final step on the pathway to FDA approval.
Number 3: To be a clinical trial participant, it helps if you don’t mind having up to 2 IV catheters plugged into your arms. And, you need to ” enjoy ” having blood drawn every 5 minutes during the critical ” high” and ” low ” period of the variability study.
Number 2: It was rewarding to spend a beautiful fall day “inside” at the old UVA Hospital — with the awesome team of researchers, doctors, nurses and clinical trial coordinators. These folks are first-class and extremely talented. A sincere “Thank you” to Dr. Anderson, all of the nurses and staff at the Clinical Research Unit, and the CDT team (Laura, Mary and Molly). And they served me a fabulous Salmon lunch when I was done!
Number 1: My blood data, CGM readings and insulin pump trend lines will be reviewed and the numbers will be crunched by the CDT team at UVA. I am contributing to a larger, multi-layered, worldwide consortium effort designed to bring the first-ever Artificial Pancreas to the commercial market — and thereby providing better health outcomes and an improved quality of life for the 3 million Americans living with Type 1 diabetes. Laura Kollar, clinical research coordinator and RN with CDT team, added this wrap up to my visit: “Just wanted to thank you (and your amazing blood) for the admission yesterday. You done good!”
It may not be newsworthy, but it’s a worthwhile contribution. Call it a legacy. Together, We R the Cure.
Here are some ” BIG PICTURES” of my day in my hometown, Charlottesville.
As I ponder the current ” Ups and Downs” of my participation in a new Type 1 Diabetes Clinical Trial at UVA, two quotes come to mind. One comes from a famous figure in American history; The other comes from my father, a UVA alum known for his wit and wisdom throughout the Anderson clan in Virginia.
“Do not put off till tomorrow what can be put off till day-after-tomorrow just as well.” — Mark Twain
“Growing old ain’t for Sissies.” — Howard Anderson
I think both are fitting words for the inconvenience, effort and the amazing satisfaction that comes from giving your own blood, sweat, and sometimes a few tears to help researchers move us all one step closer to finding a ” Cure ” or high tech solutions that will improve the quality of life for persons living with T1D. Last month I joined a new clinical trial at UVA’s Center for Diabetes Technology — my sixth trial since August 2010 — titled “Biobehavioral Mechanisms of Glucose Variability.”
Trial participants will track their insulin sensitivity results over about one month and travel to Charlottesville for an in-patient stay at UVA Hospital to measure, through continuous blood analysis, how a person responds or counters a high and a low blood sugar. A greater understanding of these issues will help researchers, doctors and digital technology leaders finish key parts of the Artificial Pancreas project — a closed-loop insulin pump technology designed to better control glucose levels in T1 diabetics and reduce the serious medical complications of diabetes.
Participating in a clinical trial is a volunteer labor of love. No one forces you to sign up. ( Attention: We need more people to sign up for clinical trials all over the world!! ). You are able to step out of a trial at any point. The truth is: it’s amazing to participate in cutting-edge medical technology like the AP and I’m hoping to benefit from the results of the research — automated glucose management that leads to better long-term health and less complications.
In a snapshot, here are the highlights of the first 3 weeks of my study. The BIG EVENT happens this week — when I complete my 12-hour in-patient stay at UVA hospital with the CDT medical team.
- Week 1: Go to Lab Corp and get pre-trial blood work done and results shipped to UVA; Travel to Cville for health screen with medical team; Attach trial DexCom 4 Continuous Glucose Monitor (CGM); Go shopping at grocery store for pre-planned meals — breakfast, lunch, dinner and snack with exact carb, protein and fat grams — to be used for my 4 Insulin Sensitivity days; Do “Twice” the number of normal finger sticks in order to record BG data in my trial meter and my own insulin pump meter — Ouch!
- Week 2: Eat 2 tasty pre-packaged meals and record the exact food nutrition information on the spreadsheet provided by Stacey Anderson, MD — who is no relation to the Anderson clan but a cool coincidence that we share the same last name; Discover that the DexCom CGM sensor applicator — does not always work and actually draws blood from my abdomen site; Keep doing the finger sticks — 9 to 10 times a day for two meters and for calibration of the CGM — Ouch!
- Week 3: Get day off from work approved; Discover that the ” hidden gem ” of the trial study is NOT going to happen yet — wearing the DexCom5 CGM prototype in addition to the DexCom 4 CGM; The DexCom 5 is being manufactured specifically to work directly with the Artificial Pancreas SmartPhone — delivering blood glucose results to the SmartPhone and not to the normal CGM receiver. This is one of the remaining “closed-loop” research items to be completed before the AP can become commercially available.
For now, that’s my story. Stay tuned for my next blog post and photos — from the in-patient glucose variability trial at UVA this coming week. Remember — We R the Cure. We R the ones who will make a brighter day for Type 1 diabetics.
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.
I want you to meet Molly. She’s a CDE and clinical nurse trial coordinator at the Center for Diabetes Technology at the University of Virginia School Of Medicine. She’s a type 1 herself who works with the famous Dr. Boris Kovatchev running cutting-edge Artificial Pancreas trials.
Earlier this year, before you ” met ” Molly — she almost became a statistic. Molly almost died in the early morning hours from a “SH event,” a Severe Hypoglycemic seizure that required EMS intervention and help from a fast-acting spouse. Instead of me trying to retell the story, here’s a link to Molly finally telling her story in her own words in DiabetesMine this August. If you or someone you know lives with Type 1 diabetes, you must read this. Of course, you’ve probably had this happen. My wife has called EMS for me but I have avoided a seizure or trip to the ER.
Here’s a life-and-death detail of Type 1 diabetes: 1 in 20 people, an estimated 2-4 percent and 6 percent in patients younger than 40 years old, will die from severe hypoglycemia. That’s having a low blood sugar that produces seizures, coma and death. Of the estimated 3 million people in the U.S. with type 1 diabetes, that’s approximately 150,000 people. That’s like wiping out Chattanooga, Tenn. or Rockford, Ill. — wiping them right off the map.
The prevention of a ” hypo event” is a deadly serious issue for T1Ds who strive for tight blood glucose control. That’s the catch-22: The better your control is and the lower your A1cs number is, the better chance you have of avoiding the serious, medical consequences of diabetes ( amputation, heart attack, stokes, and blindness to name a few).
The better your control, however, the higher the likelihood of low-blood sugar events (hypoglycemia). Wearing Insulin pumps and continuous glucose monitors (CGMs) all serve as valuable tools for T1Ds in the quest for tight control. However, reading Molly’s near-fatal “bedtime story” makes it clear to me: even the best informed and compliant PWDs ( persons with diabetes) will experience severe lows and their insulin pumps will continue to infuse insulin until the patient or an attending EMS tech turns it off manually.
That’s where the Artificial Pancreas and its Safety Supervision System can provide real technology solutions. And that’s why the AP must be available and soon.
The figure ( reprinted with permission from Molly) shows the course of her near-death experience and how the system would have intervened. Sixty minutes before the ” severe hypo” event the safety system would have alerted the patient and stopped insulin. This alert — think of it as your home’s monitoring system — can send a signal to the patient. And if the patient is sleeping or in what I call a ” diabetes fog — unaware of the pending crash.” it could send an alert to a caregiver or spouse via the system’s remote monitoring capability.
I first met Molly in the summer of 2010 when I enrolled in my first AP clinical trial at UVA. Molly, and her trials colleague Mary, are bright, engaging and positive people. Thanks to Molly and Mary, I’ve enjoyed every minute I’ve spent in the UVA trials — as an in-patient and out-patient. And even though Molly reminds me, gleefully, that her alma mater James Madison beat my alma mater, Virginia Tech, in a football game recently in Blacksburg — I can’t imagine going back to UVA in the future and not seeing her smiling face.
Molly gets ” the need” for more clinical trials and why the Artificial Pancreas is so critical to our long-term health. For all T1Ds who wake up at 2 or 3 AM to treat a low blood sugar and sit in the kitchen wondering what happens the next time our sugar drops below 40, we know why the AP and better technology must be available in the United States. The safety shutoff is available to insulin pump and CGM wearers NOW — in Great Britain. It’s time for the United States to stop leading from behind and move to the front on diabetes technology and research.
Our lives — and Molly’s life — hang in the balance.
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