In mid-January, the office of Dr. John Burd, CEO of Lysulin (and the former first CEO of Dexcom), was buzzing with activity. Having secured funding for research, Burd and his team had enrolled nearly 100 patients in an initial clinical trial to prove the efficacy of the supplement Lysulin for treating and possibly reversing prediabetes.
But by late March, his office and facilities were more like ghost labs — empty but for custodians checking on things, void of the busy hum a clinical trial creates.
Like many other promising diabetes research projects underway, the pandemic had shut them down mid-trial. Now Burd wonders if and how he’ll get them up and running again.
“I’m not going to start anything again until this COVID [mess] is done,” he told DiabetesMine. “Funding for supplement research and clinical studies is very small and difficult to obtain.”
TrialNet, one of the nation’s best known and longest running diabetes discovery programs, was hopping in January as well.
With trials looking at prevention and offsetting the onset of type 1 diabetes (T1D), they were feeling very much on the cusp of something big just after the start of the New Year.
Then, COVID-19 shut things down. Today, they’re finding innovative ways to get up and running again, but Dr. Carla Greenbaum, director of the Diabetes Clinical Research Program at Benaroya Research Institute in Seattle and TrialNet chair, worries about the near future.
“I don’t want to sugarcoat this,” she told DiabetesMine. “We have three trials (all on prevention) that are dead in the water. It’s for sure we’ve lost time and momentum there.”
The story is the same with researchers and at labs across America. 2020 began as a year of hope. With the economy roaring, foundations were flush with donations for funding projects. The NIH’s Special Diabetes Program (SDP) had been approved for another $150 million in project funding, and more and more innovative ideas were bubbling up.
The pandemic stopped it all cold.
Between losing lab access (many universities banned researchers from visiting their labs) and the national shelter-in-place orders that kept trial participants at home as well, foundations are stifled. They normally bring in — and dole out — hundreds of millions of dollars in research funding, but were crippled when fundraising events were canceled across the board and donations slowed to a trickle. Diabetes researchers tell us they felt like they were being hit from every direction.
So where are we at now? While some programs, like TrialNet, have found ways to get started again even with slowdowns, the lack of in-person work and funding threat leaves many wondering: how will they ever get going again?
Researchers and research projects in the diabetes sphere depend on funding from a variety of sources. University funding, government funding via programs such as the SDP, and grants from non-government organizations like JDRF, Joslin Diabetes Center, and the Helmsley Charitable Trust make up the bulk of it.
The pandemic has caused some serious funding worries for researchers who depend on that.
JDRF told DiabetesMine in the spring they were about 45 percent behind in their own fundraising, having had to cancel their many in-person galas and walks, and they believe they’ll see a decrease in research funding of about 28 percent.
As for how they’ll focus their funding until they get back to the prior level, Dr. Sanjoy Dutta, vice president of research at JDRF, said that for now, they’ll take a practical focus on new tools that could come to market soon.
“We are challenging ourselves to say ‘where does this lead us?’ even in cure (research). We will be product-oriented,” he said.
That does not mean just tools like CGMs or new closed loop systems already in the pipeline, he says — “there’s plenty of industry support for that now” — but it could mean focus on much smaller or faster systems than we’ve seen to date. It could also mean antigens, cell therapies, and other biologically based products.
By prioritizing research that leads towards transformational products, “We will continue to focus on improving lives,” he said.
The renowned Joslin Diabetes Center in Boston has had funding and donor challenges as well, and also had to keep their normally buzzing labs closed through the pandemic.
“The shutdown clearly slowed our research,” Dr. Jean Schaffer, senior investigator and associate research director at Joslin Diabetes Center, told DiabetesMine.
“Overall, it’s going to be hard to estimate the magnitude of the pandemic on research.”
Better news at the Diabetes Research Institute in Florida, which focuses solely on cure research. Smaller and leaner than the others, and not dependent on large, in-person events for fundraising, the DRI expects to be on track for their best-funded year ever, says Sean Kramer, CEO of the DRI Foundation.
While they were long a regional group, focusing on private donors in the Miami, Florida, area along with New York and Long Island, they are now reaching out more nationally, and finding results.
“Where others found challenges, we found opportunity,” Kramer told DiabetesMine. “In fact, it is our goal to increase donations and research funding this year.”
The Helmsley Charitable Trust, also a private org and one of the nation’s largest funders of diabetes research, has already allocated $11 million in emergency grants centering on the pandemic, along with a $5 million grant to evaluate virtual diabetes specialty clinic care.
They are, however, using a careful eye and some different lenses for now.
“We have not diverted funding from research priorities to our COVID-19 response. We have, however, made sure that we consider new research projects carefully in the context of priorities and the pandemic,” Anne Koralova, program officer at Helmsley Charitable Trust, told DiabetesMine.
“There are some projects we’d previously considered for this fiscal year that we might look to start at the beginning of the next fiscal year. These are not time-sensitive projects so we’d rather maintain the ability to be responsive to COVID-19-related needs that may arise in the fall. If we end up in a good place from a pandemic perspective, we will proceed with those less urgent projects.”
As for the government-run Special Diabetes Program, it won a short-term approval by lawmakers through late fall 2020, but will need to be renewed by Congress to continue funding after that.
So how are most researchers to continue, faced with the challenges of physical distancing, lack of access to some labs still, and the threat of dwindling funding?
One diabetes mom may have a partial solution.
Monica Westley, a former Harvard professor with a PhD from Yale in cell and molecular biology, recently helped launch a platform called The Sugar Science (TSS). It offers scientists and researchers in the diabetes field a secure online space for collaboration, brainstorming, partnering up on projects, and more.
Westley has been active in the diabetes sphere since her now 21-year-old daughter was diagnosed with T1D 7 years ago. Some years ago, she created “Sugar Mamas,” a group for women raising children with diabetes that not only offered them camaraderie and support, but hosted guest researchers and scientists to help them learn more about the disease their child was battling.
As an academic, Westley began thinking about those researchers, and what she could do to help them. This became especially acute once COVID-19 hit.
“I wanted to know what we could do to move the ball forward,” she told DiabetesMine.
She did what any smart academic would do: started asking questions. And she heard back loud and clear from scientists around the country, “If there was just a way they could communicate better together,” she said. “So I said, ‘what about a digital platform?’”
After recruiting top researchers to her board of directors, including famed Harvard biologist Dr. Doug Melton, she actually stepped down from her ‘day job’ position at Marymount California University to focus on creating The Sugar Science.
The TSS website currently has three usable tools for researchers:
The Collaborator is a bit like “scientific speed dating,” Westley says. Researchers can log on and connect with others to discuss topics, projects, grants, and more, with the possibility of finding others to collaborate with.
The Thought Experiment amps up the conversation, putting out questions and situations for others to comment on, “some controversial, some not,” she says.
Scientists can answer those questions and then, if their answer generates enough response, they may be invited to a “swarm” — a high level group that will dig deeper into research questions.
The Off the Record section is an invite-only area with a different panel for each topic, tackling these subjects in “a 45-minute totally off the record discussion.”
The idea is to give researchers a chance to brainstorm, find new ideas and link up with others to collaborate, right from their own lab — or in this pandemic — their own couch.
Westley worked on this project long before COVID-19 came to this world, but she realizes the timing now is just right.
With scientists stuck at home and many still out of their labs, they are hungry for collaboration and support. “We’ve gotten a lot of positive feedback already,” she said. “There’s such a need now. They all feel so disconnected. The Sugar Science is helping.”
In September they will launch their first “Pitch Competition.” Open globally, it will invite researchers to submit a 3-minute pitch with three slides. Cash prizes will go to the top three, as chosen by a review committee, and one people’s choice award.
She’ll also launch a fourth section of the site soon, one that allows the general public to share information and data. Westley said she’s not ready to reveal details of that just yet.
Westley’s TSS team is dialed in: everyone on it has a direct connection to diabetes. Many of her interns, who do hand’s-on work, were culled from the College Diabetes Network.
So far, just weeks into operation, the TSS seems to be successfully helping scientists meet up and find connections, although they don’t necessarily track details of what those connections lead to.
“We want to introduce folks, but we don’t want to go to their wedding,” she said.
The good news is: diabetes researchers are a resilient group. And some of the effects of the pandemic have inadvertently been a cause for good.
For example, while Joslin still remains partially closed down, their researchers have pivoted and found ways to charge ahead.
“Most all of our studies had to transfer to virtual,” Schaffer said. “It has been a bit of a challenge, but they are doing well. And in the past two months, I’m happy to say, most of our research projects are going again. They’ve honestly made a herculean effort.”
“Clearly [the pandemic] is going to contribute to delays in publishing, and increased costs to restart trials,” she added.
But she also believes the fact that diabetes presents possible high-risk for recovery from COVID-19 may help the cause of diabetes research more broadly.
“We need to understand why people with diabetes may be at high risk [for recovery],” she said. “Getting to the point of understanding that could have incredible benefits for understanding the biology of diabetes overall.”
At TrialNet, developing online systems and at-home screening had been a priority for some time. COVID-19 and the shutdown pushed that forward, with good results, Greenbaum said.
“Screening had essentially stopped, but now we are seeing a huge increase in home testing,” she said. “This is the direction we needed to go in anyway, and this just sped it up.”
There has also been an influx of study funding money around COVID-19, something Greenbaum and her team at Benaroya Research Institute took advantage of. “After all, we are all about immunology,” she said.
But she does not see that as the permanent solution. “We don’t want to become a COVID institute,” she said.
The other silver lining?
“This whole exposure of the population to the process of science has been good,” Greenbaum said. “People are recognizing that biology is tougher than technology. That’s a great thing, going forward, for people to understand.”