When a new product or medication finally makes it to market and into the hands of PWDs (people with diabetes), we often forget about the monumental effort it took to it get there. The necessary research and development, clinical study coordination and regulatory review is a complicated process that takes years to complete, and most of us patients never get to see. But do you ever wonder who the brains are behind getting all that research from Point A to Z?
Say hello to the Jaeb Center for Health Research (JCHR), a key national player in coordinating clinical research and assisting in the development of new products, treatments, and even cultural shifts in how we manage diabetes.
From its headquarters in Florida, Jaeb has been coordinating multiple studies at more than 80 participating clinics in 33 states around the country, including Stanford University in California and Henry Ford Health System in Michigan, to name a few. The 130-person staff includes 33 epidemiologists and statisticians, 35 IT people, 45 protocol monitors and research assistants, and 17 central administration positions. At the moment, the center is involved in about 25 diabetes or eye disease studies -- all with human subjects, of course.
One leader in the D-research world refers to the Jaeb Center as "the engine required to support clinical research."
The story behind Jaeb
The JCRH in Tampa, FL, is a nonprofit that’s been around since 1993, and the man heading up the R&D coordination hub, Dr. Roy W. Beck, has a very personal connection to type 1; his son Andy was diagnosed at age 12 in the 90s.
Before Beck became a D-Dad, he was a neuro-ophthalmologist practicing at the University of Michigan. Eventually, he started getting involved in clinical trial research and moved to Florida in the late 80s, pursuing research and funding from the National Institutes of Health (NIH). But as he says it, the “bureaucracy of being part of a university became too frustrating” and he decided to go off on his own.
Beck created a separate nonprofit center, naming it after his three children. JAEB is his children’s initials in order of their age – Jody Andy Eric Beck. It’s the A who has T1D, he notes.
He managed to secure several NIH grants relating to eye disease, including that first one in 1985 for studying an inflamed optical condition related to MS (multiple sclerosis). That research and clinical trial coordination for eye disorders was where Jaeb started, before diabetes came into the picture when Andy was diagnosed.
“After a few years of being a parent living with this every day and learning all about it, I was able to tell people that I essentially completed a diabetes fellowship at home,” Beck says. “Those were the days before widespread Internet, and we really knew nothing about the practical side of type 1 in children. So after a few years, I decided to use my time and center’s resources to work on studies for type 1 diabetes, because of that personal connection and because I felt like I understand that from the perspective of a statistician and epidemiologist.”
What does Jaeb actually do?
The center's all about the design, implementation, and analysis of clinical trials for eye disorders and type 1.
When companies are researching new medications, products, standards or treatment options, there's a whole host of nuances that have to be managed -- from vetting all the sites and doctors to be sure they all have the necessary credentials, to creating the protocols for how the studies will be conducted and data analyzed, to how that will be compiled to prep for FDA regulatory review.
Here's a look at their to-do list:
- Ensuring funding for the studies
- Coordinating everything at each research site
- Generating all the necessary forms that outline the study and its procedures for review by the doctor
- Determining how data will be collected and analyzed in a particular data management system
- Developing protocols for how patients will be selected and randomized
- Making sure all of the needed devices and supplies for the study at each site are coordinated
- Quality assurance and statistical analysis of everything involved
- Writing the manuscripts and research articles for scientific meetings, which play the important role of spreading word about the research throughout the medical community
Handling all this behind-the-scenes work, the center may be considered the unsung hero in diabetes research trials. Obviously, it's not involved in every study. But it has a pretty impressive track record on all the projects it's participated in through the years.
Beck says while Jaeb was well-recognized nationally in eye research in those early years, he didn’t know the diabetes researchers very well. But roughly around the start of the new century, he applied for an NIDDK program during a call for new research projects across the U.S. in 2001, and that first venture into diabetes led to what is now known as DirecNet, a network designed to study glucose monitoring tech in T1 kids.
You name it, Jaeb has snagged some funding -- including big diabetes money-handlers in research like Helmsley Charitable Trust, JDRF, ADA and the NIH (among others).
Several years ago, Jaeb aligned with the T1D Exchange that's also funded by Helmsley Charitable Trust. You may remember the headlines on how Helmsley donated $26 million to Jaeb in 2010 as part of a three-year funding initiative to create a network of clinics in diabetes research. That paved the way for the T1D Exchange Clinic Registry, which became the backbone of those 80 sites across the country, bringing more than 30,000 people with T1D into a single research repository.
"We thought we'd get 25 centers, and ended up with more than three times that many!" Beck says. "We collected records on everything from management habits to medications and meals, and we've learned an incredible amount from this registry."
One example: learning how electronic health records (EHRs) weren't effective in collecting data in large part because the questions posed and bits of info collected from patients were not universal.
Based on this expertise, Jaeb has been involved in a number of important diabetes studies through the years on children and adults, investigating:
- Technology to understand insulin management during exercise
- Managing snacks overnight to combat hypoglycemia
- Brain imaging to determine the effects of hypoglycemia on cognitive development
- Outcomes of CGM technology in schools, with the aim of improving how insurance companies would cover that technology. (They did the first-ever study to show how CGM can actually improve outcomes)
- Artificial Pancreas and closed loop research, including groups involved with the Bionic Pancreas and iLet closed loop device among others. (This has been the largest area of growth for Jaeb in the past decade)
- Severe hypos in older adults, which they found were more common than in other groups -- this was presented at conferences over the past year to illustrate why CGM can be an important tool for those on Medicare
- Racial disparities in the care and self-monitoring of people with diabetes
- Metformin use in teens with type 1 who are on insulin
Some serious diabetes expertise, indeed! And that's just a taste of what Jaeb has done so far.
Getting new diabetes technology to market
Needless to say, Jaeb’s research plays a key role in getting new diabetes tools and treatments to market.
For example, Jaeb and the T1D Exchange conducted the key research behind the nasal emergency glucagon that became Baqsimi, from Eli Lilly. The FDA just recently approved this revolutionary product originally developed by Locemia Solutions . It replaces the overly-complicated mixable emergency glucagon injection that's been around for years.
We reported previously on this glucagon you sniff up your nose, and I had the fun of participating in one of the clinical studies of this novel new powdered glucagon!
The Jaeb Center was instrumental in getting these studies done as the coordinating center.
Another example of Jaeb’s coordination of pivotal studies is that leading to FDA approval of Tandem’s t:slim X2™ insulin pump with Basal-IQ® technology.
And even more recently, the Jaeb Center coordinated the clinical trial demonstrating the efficacy and safety of the Tandem pump with its newest Control IQ software that automates insulin delivery. This study was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) through a grant to the University of Virginia, and Tandem is using the results to hopefully get approval of Control-IQ before the end of 2019.
Why does it matter?
It’s tough enough to get people interested in diabetes research, let alone get enough patients involved directly. For many years, I personally resisted the urge to sign up for clinical trials because I didn’t see any immediate "return on investment," i.e. no tangible result of my participation.
But over the years, I’ve grown in how I think about diabetes research. It really is about the greater good and future generations, even if there won't be any immediate, tangible benefits for me (other than special attention by experts and sometimes free supplies).
Time and again over the past few years, I’ve had friends pass along info about a particular research project that may be of interest... And now, knowing the story behind Jaeb definitely makes me feel more invested in future studies. I like that can see the center’s name now and know, “Hey, that’s the D-Dad who named his nonprofit research hub after his three kids!”