Clinical Studies Are Recruiting for Participants; We R the Cure — Is It Your Time?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge.

Before leaving UVa and giving back the AP, I pose with a few of the team members who watched over me and conducted the outpatient trial. L to R: my nurse, Crystal Leathers, computer engineer Benton Mize, and Stacey Anderson, MD.

There are two main types of clinical studies: clinical trials and observational studies. ClinicalTrials.gov includes both interventional and observational studies.

Searching for a Type 1 Diabetes Clinical Trial? Check out the current list of trials in the United States.  Searching for a Type 2 diabetes clinical trial?  Click this link.

Diabetes Technology: What Patients Really Want — The Video

UVA Artificial Pancreas Team Receives $3.4 Million Grant; Technology Aims To Transform The Lives Of Type 1 Diabetics

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 Center for Diabetes Technology Team at UVA is part of a worldwide Artificial Pancreas Consortium working to bring a safe and high-tech Closed Loop System to Americans with Type 1 diabetes in the next few years!

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

Clinical Trial At UVA Marches On: Giving My Blood, Time And Type 1 Diabetes For Artificial Pancreas Research

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.

The Clinical Trial is done at about 4 pm and I can enjoy a beautiful fall afternoon and a Starbucks coffee in Charlottesville, my hometown.

Keeping track of the blood glucose ” highs and lows” during my Clinical Trial at UVA.

My blood samples are lined up at UVA Hospital during Clinical Trial on November 7. It looks like a lot but the total volume taken is about the same or less than a normal blood donation.

Automated blood machines are used to analyze and report on my blood glucose levels and other key metabolic factors during my in-patient admission.

Wearing Artificial Pancreas In UVA Clinical Trial: Sugar In Range, Freedom and Coolness — I Felt Like “Iron Man”

The AP SmartPhone is secure inside a prototype box, affectionately nicknamed ” THE BRICK ” by the UVA research team. Brick 1 also contains my CGM and Bluetooth communications back to the trial control computers.

AP SmartPhone shows Flat Line 167 mg/dl of awesome glucose control after dinner and prior to bedtime on March 14, 2013.

The AP Smartphone shows the obvious benefits of my 45 minute walk in Charlottesville’s Downtown Mall. AP is adjusting background insulin dose to bring my post-lunch glucose down and keep me from a crashing low.

Boris P. Kovatchev, Ph.D, and I show off the AP after my afternoon walk. Dr. Boris is the Director of the UVA Center for Diabetes Technology and the person who is building the ” brain ” or algorithm that makes the AP possible.

Dr. Daniel Chernavvsky, Clinical Research Coordinator, and I display the AP as the 24-hour clinical trial ends March 15. I did NOT want to give it back to him. I’m sure he was watching me closely, LOL.

Before leaving UVa and giving back the AP, I pose with a few of the team members who watched over me and conducted the outpatient trial. L to R: my nurse, Crystal Leathers, computer engineer Benton MIze, and Stacey Anderson, MD.

OK, so the headline might be a little bit over the top.  My apologies. However,  I was wearing the ” Future ” of high tech diabetes self-management, and it was amazing, incredible and a breath of fresh air.

I was blessed to actually plug in and wear the Artificial Pancreas in a human clinical trial at UVa on March 14 and 15.  The AP is not exactly like clicking the Arc Reactor into your chest, but the two devices are similar. It is a new, high-tech device that brings the promise of:  better health; less daily stress for you and your family, and the powerful hope of fewer long-term medical complications from diabetes such as blindness, heart attacks, strokes and amputations.

For 24 wonderful hours, I felt like Iron Man — without the cool cars, the ability to fly, the Malibu mansion or the lifestyle of Robert Downey, Jr. But the experience was still “Super Hero-like” for someone like me who has battled the ” Super Villan”  Type 1D for 14 years and been unable to achieve consistent glucose control. The AP is not a cure for diabetes, but it does offer a solution or pathway to better health outcomes for the 3 million Americans living with Type 1 diabetes.

After missing an opportunity to participate in the last AP trial, this time I passed the FDA’s strict health screening ( done May 11)  and was invited by the research team at the UVA Center for Diabetes Technology to participate in a shortened outpatient trial. Recently, the UVA team successfully completed a 48-hour pilot study with 5 individuals — to prove that a ” wearable AP is feasible and safe; therefore its continued testing and refinement for outpatient use is warranted,” according to Boris P. Kovatchev, Ph.D., the lead investigator and Director of the center.

In the prior study, the AP participants led a ” normal ” life and were able to eat and sleep without the constant finger pricks and mental burden of ” how’s my sugar doing now?” Check out Tom Brobson’s video story of his UVa trial experience. This was the first out-patient study done in the United States.

As a follow-up to this clinical trial, my one-person study was not designed to test the AP algorithm or to determine if the software worked.  We know the AP works — and it worked again for me in this trial!  The UVa team called me for a ” dry run”  test to see if a new hardware solution — a fix to provide an uninterrupted source of power to the AP and the CGM — would prevent the battery ” burn out” that happened during the previous trials. This is where ” BRICK 1 ” comes in.  The researchers designed a new power and communication system to be combined within one unit. The good news: the ” Brick” designed appeared to work exactly as the researchers expected during my 24-hour test, providing consistent data reporting with no gaps!

The team put the AP SmartPhone, CGM, Bluetooth wireless communication equipment all together in ” Brick 1″ — this is what I carried with me and how I communicated with my insulin pump. And instead of staying put in a hospital or hotel room, I was able to carry the AP/CGM Brick with me as I walked to dinner at the College Inn on ” The Corner” across from campus and again for lunch on Friday. As Dr. Boris joked with the local NBC TV reporter, “this is the first time ever anyone with the artificial pancreas has been outside walking in a parking lot.”  One small step for man, one giant leap for AP research!

Dr. Boris, Dr. Daniel and Benton Mize, the computer engineer working on the AP design,  said the Federal Drug Administration (FDA) — which is regulating and monitoring all human clinical trials performed in Charlottesville and the 4 other AP consortium universities in the USA, France and Italy — needs clinical proof the technology works and that patients in non-hospital trials will be safe from low glucose episodes. The technology must give researchers uninterrupted remote monitoring capability of participants on a 24/7 basis when AP home trials start in 2014.

My bottom line — the AP worked as advertised.  I was involved in determining my meal boluses and counting my carbs ( the control factor). The AP was able to operate in ” safe mode ” while I slept and ” closed loop” mode while I ate dinner or exercised. It essentially acted like a normal pancreas does providing sugar control automatically. The CGMs and the AP monitored my sugar every 5 minutes and adjusted by basal rates ( baseline insulin dose) up or down to help me achieve the best possible glucose control with the least amount of work.

And thanks to the AP and the awesome team at UVa, I had the freedom to go to bed and sleep all night with no 2 am lows. I maintained a Flat Line sugar reading overnight and woke up the same — and that’s a “Super Hero” result and the promise of a bright future for everyone living with Type 1 diabetes.

Next post: I’ll add a few more observations from my clinical trial; Dr. Daniel’s trip to the University of California for a new outpatient clinical trial with the AP and “BRICK 1”;  and Dr. Boris’ talks with manufacturers to get better quality technology for the AP.

Independence Day Coming: FDA Gives OK To OneTouch To Send Blood Glucose Results Wireless To iPhone, iPad or iPod

News We Can Use, March 4 via PRNewsWire 

When it is ready, the AP Algorithm will run on any SmartPhone and fit in your pocket.

— LifeScan, Inc. announced today that the OneTouch® Verio®Sync Blood Glucose Monitoring System has received clearance from the US Food & Drug Administration (FDA). It is the first meter to automatically send blood glucose results wirelessly via Bluetooth technology to an iPhone, iPad or iPod touch using the OneTouch® Reveal™ mobile app.

“For so many people, their iPhone, iPad or iPod touch have become a tool of choice to help organize and take charge of their daily lives,” said Ty Lee , Vice President of Marketing, representing the products of LifeScan, Inc. & Animas Corp. “For people with diabetes, the new OneTouch® Verio®Sync System will enable them to use their iOS device to view and share their blood glucose results wirelessly, in much the same way they rely on them in other areas of their lives.”

Through the OneTouch® Reveal™ mobile app, users will be able to view a variety of personalized information directly on their iPhone, iPad or iPod touch including a 14-day summary of blood sugar test results, simple visuals showing the percentage of test results within target range, and then share that information via email or text with their care providers, family or friends.

People with diabetes interested in learning more are encouraged to visit www.OneTouch.com where they can sign up to receive email updates on availability and special introductory offers for the OneTouch® Verio®Sync System.

Until There’s a Real Cure For Type 1 Diabetes, the Artificial Pancreas is the Techno-Cure

Graphic showing Artificial Pancreas "closed loop" system currently being developed by leading researchers. Photo courtesy of The AP Project

For the 3 million Americans who are living with Type 1 diabetes, the artificial pancreas project represents a Cure. Well, more like a Techno-Cure. AP technologies have the potential to be the most revolutionary treatment since the discovery of insulin 90 years ago! In future posts here, we’re going to exam the AP in detail and some of the basic questions that keep all of us awake at night:

• How much money will it take to develop these treatments and cures?
• The human body is a complex machine created by a higher authority than man. Can we ever truly understand autoimmune disorders?
• Will there ever be a true “cure” for diabetes? Or I am just playing the part of Indiana Jones, traveling on a life-long journey or quest for “The Holy Grail?”

We R the Cure is dedicated to providing information, breaking news and key opinions to this discussion. Want to know more about the AP trials at U.Va? Here’s a comprehensive video from a “patient’s view” of the artificial pancreas project being conducted at the University of Virginia and its peer institutions in the United States and overseas.

As the search continues — amazingly, it’s been 42 years since the JDRF was founded (1970) by parents who were not satisfied with the pace of scientific research — we push for prevention, treatments and technology solutions that will produce tighter glucose control and reduce the serious life-threatening complications. We look healthy on the outside. But we’re dying on the inside. In the coming weeks, we’ll start answering those nagging questions about research dollars and the search for Cures. Your comments and questions are always welcome here!

Diabetes Costs Money, Takes Lives

Each year, more than 15,000 children and 15,000 adults, approximately 80 people per day, are diagnosed with T1D in the U.S?!

• Type 1 affects as many as 3 million people in the U.S. alone, and results in nearly $15 billion in healthcare costs each year.

• Contrary to the misconception: 85 percent of people living with type 1 diabetes are adults. Obviously, a lot of young children have grown up. Now they are adults with Type 1.

• The average annual medical costs of kids and teens with diabetes is $9,000, compared to $1,500 for those who don’t have diabetes.

• The rate of type 1 diabetes incidence among children under the age of 14 is estimated to increase by 3% annually worldwide.

And the climax:

• 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.
• So, that’s why we push the FDA, our family, friends and total strangers — for greater awareness and more money. We need better technology, new solutions and real Cures. The future’s so bright, we gotta wear shades. But if you’re living with diabetes, it’s not coming fast enough. Will you help?  We R the Cure.