At ADA, JDRF-Funded Research Takes Center Stage (featuring a “Happy Hour” with Dr. Aaron Kowalski)

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At the American Diabetes Association’s Scientific Sessions, which was held virtually from June 12-16, scientists presented on some of the most important topics, from artificial pancreas trials to immune therapy trials to prevention trials, all with the same goal: ending type 1 diabetes (T1D) and improving lives until that day comes. JDRF played the roles of presenter, educator and active learner—and was the key funder and supporter of nearly all of the top advances shared at ADA. Here is Aaron Kowalski, Ph.D., President and CEO of JDRF, with the biggest takeaways from the conference, and there is a summary of JDRF’s highlights below.

Improving Lives

The Next-Generation Artificial Pancreas Systems

JDRF Research Area: Artificial Pancreas

In 2016, the Medtronic 670G was the first artificial pancreas system to come to the market, but it had some issues, like all first-generation technology. The Medtronic 780G continues to improve on it. In the pivotal U.S. trial, time-in-range was around 75% (more than the previous Medtronic systems), and it automatically corrects high blood sugars with boluses. Therefore, there is no sustained high blood sugar (hyperglycemia), as seen in the 670G. What does this mean for the T1D community? More freedom. (And, the day before the presentations, the 780G received CE Marking—the European equivalent of FDA approval.)

But that’s not all. The Omnipod 5 (previously called Horizon)—which pairs its disposable insulin pump (which you can change every 3 days) with a Dexcom G6 continuous glucose monitor (CGM)—got a time-in-range of more than 70%. This means more choice for people who want to use a hybrid closed loop system, especially for those people who don’t want wires all around them.

JDRF Leadership: JDRF was an early and ongoing supporter of this work. We launched the Artificial Pancreas Project in 2006, leading efforts to accelerate the development of artificial pancreas systems, and worked with the FDA to pave a clear pathway to regulatory approval.

Another CGM Authorized in the U.S.

JDRF Research Area: Glucose Control

Abbott announced that the FDA has authorized the FreeStyle Libre 2 System for adults and children 4 and up in the United States. It’s a 14-day CGM system that transmits data every minute and now includes customizable high and low alerts without the need to scan the device. It was authorized as an integrated CGM (iCGM), meaning it can be a part of an interoperable system in the future. This makes the FreeStyle Libre 2 the second CGM on the market to receive this designation.

JDRF Leadership: A JDRF-funded clinical trial conclusively demonstrated that CGM use improved health outcomes for people with diabetes, helping them to avoid blood sugar highs and lows, which led to widespread coverage of CGM by insurance companies. The clinical trial was heralded as one of the top 10 medical breakthroughs by ABC News.

Two Drugs Preserve Beta Cell Function

JDRF Research Area: Glucose Control

In two phase 2 studies in recently diagnosed people with T1D—one in children and young adults and the other in adults—golimumab (Simponi®), which targets an immune messenger molecule, and a combination of anti-IL-21, which targets a different immune messenger molecule, and liraglutide (Victoza®), a GLP-1 agonist, showed that they preserved beta cell function. This means that they preserved individuals’ ability to create their own insulin, requiring less injected or infused insulin.

JDRF Leadership: JDRF is insistent on the need to have more and better therapies for T1D; many people do not reach their desired HbA1c target goals and we still have hypoglycemia occurring in many people. But we are the cusp of potentially 3 or more disease-modifying and preventive treatments—this is unprecedented and promising.

Cures

Immune Therapy Delays T1D for Almost Three Years

JDRF Research Area: Immune Therapies/Prevention

Last year at ADA’s Scientific Sessions, a drug, called teplizumab, was able to significantly delay—for over two years—the onset of T1D in participants with a high risk of developing the disease. This was the first ever study in humans to show a delay in the onset of T1D. But it doesn’t stop there. Over the past year, the investigators followed up on the individuals who didn’t develop clinical diabetes, and the effect of teplizumab had been sustained: 50% of those treated with teplizumab remain diabetes-free, compared to only 22% of those who took a placebo, and the delay in the onset of T1D was almost 3 years—adding a year to the previous results. This is the first preventive and disease-modifying drug with data showing a long-term delay to insulin dependence.

JDRF Leadership: JDRF co-funded one of the first clinical trials of this drug, results of which were integral to the teplizumab prevention trial. The study in this report was conducted by TrialNet, a T1D trial consortium funded by NIDDK and by the NIH’s Special Diabetes Program, for which JDRF is the leading advocate. Multiple studies involving samples and data from teplizumab trials have continued to receive JDRF funding. Teplizumab (now called PRV-031) is currently being tested in a phase 3 clinical trial in people recently diagnosed with T1D, headed by Provention Bio, a company with an investment from the JDRF T1D Fund. If successful, this could become the first immune therapy approved for T1D.

Microbiome: Up-and-Coming Treatment

JDRF Research Area: Prevention

The human digestive tract hosts a community of trillions of microbes—called the microbiome—that play an important role in our immune system. Results show that they are markedly different in those that develop T1D. A clinical trial tests a new treatment for T1D: fecal transplantation (yes, we’re talking about poop). The investigators asked: “Can fecal transplantation improve beta cell function in people recently diagnosed with T1D?” And guess what? It does! HbA1c went from 9.3% to 6% to 7%, and it remained so for 12 months. What it means for the T1D community: it may be possible to extend the “honeymoon period” (the time immediately following diagnosis, when the pancreas is still producing insulin) for just diagnosed people.

JDRF Leadership: JDRF has been focused on the microbiome since 2008, when the JDRF-funded study demonstrated that the microbiome is a critical factor in modifying T1D susceptibility. Now, the JDRF Microbiome Consortium and JDRF-funded research teams are working to reset or alter the human digestive tract microbes, which may prevent the onset of T1D completely.

By Alexandra Mulvey