A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies. ClinicalTrials.gov includes both interventional and observational studies. So, what R U waiting for … Think about joining a clinical trial in 2014. It’s a new year’s resolution that is worth keeping. Thanks for your participation. werthecure.com
Welcome back to We R The Cure, 2014 Edition. I am happy to be back among the Diabetes Online Community.
Yes, I’ve been away enjoying Christmas, New Year’s, working, searching for new work and — most importantly, focusing on what matters the most to me: Family, Friends and Faith. If you guessed that what matters most is my Type 1 D, well — you were close but wrong. Of course, it should have been a multiple choice answer.
If you are a person living with Type 1 diabetes, managing your sugar highs and lows is ALWAYS on the list of what matters most. Healthy and active on the outside; dealing with a chronic, life-threatening disease on the inside. It is a frustrating condition for the 3 million Americans — toddlers, children, teens and young adults — living with it.
A new year is here, and it’s time for me to join the “New Year Resolutions” chorus and to get my editorial content calendar back ON THE GRID. So here goes my Top 5 list of what We R The Cure will focus on in 2014. Of course, the numerical ranking may switch or slide during the year. What is number 1 today, may be number 2 by year’s end. But you get the idea.
- Tell the story of my Aunt Mary Jane. A Joslin Center Medalist who’s been living with Type 1 diabetes for 7 decades and is still waiting for the cure they promised her back in the 1940s. She’s a survivor who has lived the ups and downs of diabetes since the age of 7. She’s got a story to tell.
- The focus of ” We ” R The Cure is the amazing Type 1s, the researchers, the doctors, and the clinical teams pushing hard to bring tech solutions like the Artificial Pancreas to market. The focus is on all clinical trial participants. If you are participating in a clinical trial and want to tell your story — please contact me. Your story needs to be told. And we need to encourage more Type 1Ds to seek and participate in clinical trials. We need more guinea pigs.
- Research and technology “News that we can use.” As a former reporter, my job is to highlight and interpret the daily digest of exciting and confusing news surrounding Type 1 and Type 2 diabetes.
- Wearing My new DexCom 4 and, hopefully, the DexCom 5 in Clinical Trials at the Center for Diabetes Technology at UVA. The DexCom 5 will send its results directly to the Artificial Pancreas smartphone and not to the transmitter. This must be tested and proven successful before “Home” AP trials can begin in 2014.
- Biking for the Cure in 2014. Finally putting this on my ” bucket list” and doing it. The target goal: Riding 60 or 100 miles, raising money for diabetes research, and keeping a journal about my training and crossing the finish line.
OK, there it is. I’ve placed my resolutions and goals online. WeRThe Cure is ready for another year — year 16 — of balancing life and diabetes. With the love and support of my spouse, family and friends — 2014 will be another great year.
Thanks for reading. Please comment or share ideas or stories.
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.
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.
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
First, my apologies to followers or readers of We R the Cure — I’ve owed you a follow up to my experience wearing the actual Artificial Pancreas in a clinical trial at UVA since late March. Here is part 2.
Second, the headline of this post could have been written by thousands of Americans who are living with Type 1 diabetes and keeping ” Hope Alive ” that a solution like the AP is coming. Of course, solutions and “cures” have been promised by doctors, researchers, fundraisers and good-hearted volunteers for decades. I don’t believe in the tooth fairy either.
So rather than bore you with my prediction of when the AP will be built, approved and commercially available, I suggest you Google or Bing the topic and take a deep dive into the facts and the promises surrounding ” WHEN ?”
Here are some of the things I learned from my 24 hour period with Dr. Boris Kovatchev and his amazingly talented team of doctors, nurses, researchers and technology pioneers at the UVA Center of Diabetes Technology in Charlottesville, VA. Hopefully, you’ll see something here that gives you a dose of optimism for our future. A future filled with less daily stress and better diabetic health.
- Dr. Boris said he’s having ongoing talks with insulin pump companies, smartphone technology providers and other manufacturers. His message is: the AP worldwide consortium needs better high tech equipment — to get the AP prototype to the finish line faster. If the human clinical trials continue to meet and surpass expectations, there is an expectation that manufacturers will remain fully engaged.
- Attachments. I was wearing a 3 ring circus of “stuff” during my AP clinical trial: A) basic Tandem t:slim insulin pump, B) Two, yes 2, Dexcom 4 CGMs, and C) A Sony droid smartphone and CGM receiver with a “brain” — an algorithm designed to react to my blood sugar readings every 5 minutes and make adjustments if needed to keep my levels as close to ” a control or flat line” reading. Being a human pin cushion is the downside of participating in a diabetes human clinical trial. In the future, the technology must evolve so Type 1 Ds will feel more like ” IRON MAN ” — wearing the coolest technology — and less like ” FRANKENSTEIN” with bolts in my neck. Despite the tubing, monitors and fanny pack, I did not look like the patients who wore their insulin pump strapped to their back like a Jet Pack in the early days of diabetes research.
- Attachments, Part 2. The good news is : The smartphone and CGM technology is working and all happens via Wi-Fi and Bluetooth. Very Cool. Very Exciting. You can carry it with you and walk without an IV or extension cord when you go out for lunch and dinner. I felt kinda like a lab rat walking free. That is what the AP offers Type 1′s – a dose of freedom from diabetes management.
- The new power/hardware design appeared to work well in my trial. Next step for the UVA team: Repeat the software and hardware clinical trials performed at UVA at the University of California at Santa Barbara in May with 5 participants. If it works well there then the next step is to take the AP prototype to the consortium partners in France and Italy and repeat the same trials overseas.
- Gather the research evidence from all of the 2013 trials and present it to the FDA and others who are involved in the AP project. Report the findings and set up the 2014 human clinical trial test agenda: AP home trials. Yes, home trials with remote 24/7 monitoring of patients who are wearing the AP prototype as they go about their normal daily routines ” OUTSIDE ” of the research hospital settings.
- Finally, as I was wearing the AP for 24 hours — Dr. Boris and his research team was montoring my glucouse control from the hotel room adjoining my room, or from their UVA office on Main Street or — better yet — from their laptop while sitting in the Atlanta airport waiting for a flight back to Charlottesville. The device is capable of 24/7 remote monitoring access. Amazing.
I’ve got renewed hope and excitement about the AP. How long before we’re all able to wear one? I’m hoping for three to five years. It’s going to take
more time, brains, private sector investment and more research dollars to make this a reality. As many Type 1 Ds or Diabetes Online Community members have said before me: ” the solution is coming; it’s my job to keep myself in the best possible shape — to closely monitor and control my sugar levels — so I’ll be healthy enough to benefit from the AP when it arrives.”
It’s not a cure for diabetes. That’s still our goal. But, the AP ship is sailing on the horizon and is about to dock. I want to be ready when our ship finally comes in.
The future of improved diabetes control is coming fast; it’s kinda like the small light at the end of the tunnel. The light is a freight train carrying the Artificial Pancreas Closed Loop solution currently being tested and in trials at the Center for Diabetes Technology at the University of Virginia and 4 other leading universities in the world.
With Full Disclosure and Much Credit — Here is a recent Podcast done by my friend, Tony Rose, who is a veteran contributor to the Diabetes Online Community (DOC), a fellow PWD and someone I called when I was starting Werthecure.com this year.
“In this episode of the Blogging Diabetes Podcast I talk to Lesley Berchtold about her history with diabetes and more recently, her in and out patient trial at UVA for the Artificial Pancreas. It was an eye opening interview that I certainly learned a lot from and appreciate Lesley talking about her experiences,” Tony blogged earlier this month.
If you’ve got feedback, comments on the APP or wish to “blog” about something in this space — let me know. It’s an open forum for Type 1 diabetes, research and clinical solutions and for the people who are living and thriving with this chronic disease. We R the Cure.
Next Month: How to react positively to a bad A1c report.