Breakthrough T1D was there when the top type 1 diabetes (T1D) experts from all over the world convened this month at the American Diabetes Association’s (ADA) Scientific Sessions in San Francisco, which was held June 7-11. Breakthrough T1D played the key roles of presenter, educator and active learner—and was the key funder and supporter of nearly all top advances shared in T1D research. There were two fantastic results that came through the ADA’s Scientific Sessions—one for cures, and one for improving lives—and noteworthy results from other key areas. These clinical trials and Breakthrough T1D-funded research studies are paving the way to novel and emerging treatments and technologies for T1D.
Cures
Immune Therapy Delays T1D for More than Two Years
Breakthrough T1D Research Area: Immune Therapies/Prevention
Dr. Kevan Herold, of Yale University and a longtime Breakthrough T1D grantee, presented exciting results: For the first time ever, an immune therapy treatment was able to significantly delay—for over two years—the onset of T1D in participants with a high risk of developing the disease. The drug, called teplizumab, targets CD3, a blood marker that activates the immune system’s T cells, to suppress the autoimmune response. With these results, and the drug continuing to a phase 3 clinical trial, we’re moving even closer to a world without T1D.
Breakthrough T1D Leadership: Breakthrough T1D funded one of the first clinical trials of this drug, results of which were integral to the teplizumab prevention trial. This study was conducted by TrialNet, also funded by Breakthrough T1D and by the NIH’s Special Diabetes Program for which Breakthrough T1D is the leading advocate. Teplizumab is now 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 T1D Fund. If successful, this could become the first immune therapy approved for T1D.
Bio-Synthetic Materials: Where We Are, Where We Want to Be
Breakthrough T1D Research Area: Beta Cell Replacement
Cell encapsulation could, in theory, allow people with T1D reap all the benefits of beta cell replacement without the immunosuppression, which can leave people with T1D at risk for infections and cancer. Omid Veiseh, Ph.D., shared research on an encapsulation approach that is halting the immune attack on beta cells. An islet plus a polymer, he said, gives a porous protective coating that allows nutrients and oxygen in, but keeps immune cells out. When transplanted, however, these encapsulated islets become covered in scar tissue, which makes the beta cells no longer permeable to oxygen and nutrients. He and a team of researchers have developed an encapsulation therapy that keeps the beta cells alive for up to 6 months in an animal model.
Breakthrough T1D Leadership: Breakthrough T1D catalyzed encapsulation research and attracted people into the field, including Dr. Veiseh. His research eventually led to the discovery of an encapsulation platform, and he founded, with four others, Sigilon Therapeutics. Announced in 2018, Sigilon will collaborate with Eli Lilly to develop therapies for T1D, using technology that began with Breakthrough T1D funding.
Improving Lives
An Artificial Pancreas System Met Each of Its Endpoints
Breakthrough T1D Research Area: Artificial Pancreas
A new artificial pancreas system was presented by Sue Brown, M.D., of the University of Virginia. The clinical trial, with 168 participants, met all of its primary and secondary endpoints, including time-in-range and HbA1c, with no fingerpricks. What’s more: participants rated it high on ease of use and desire to continue use after the trial’s completion. The device is a combination of Tandem’s t:slim X2™ insulin pump with Control-IQ™ advanced hybrid closed-loop technology and Dexcom’s G6 continuous glucose monitor (CGM).
Breakthrough T1D Leadership: Breakthrough T1D 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. This study was funded by the Special Diabetes Program, which has been renewed by Congress numerous times thanks to leadership by Breakthrough T1D.
New Partnership to Improve Pump Technology
Breakthrough T1D Research Area: Artificial Pancreas
Two leading innovators in the T1D space—Tidepool and Medtronic—announced a partnership to enable people with T1D to create their own automated insulin pump systems using devices from different companies. Through the partnership, Medtronic pledged to develop a Bluetooth-enabled MiniMed™ pump that would be compatible with the Tidepool Loop, an open-source automated insulin delivery app.
Breakthrough T1D Leadership: Breakthrough T1D is an early and ongoing supporter of Tidepool and was the first to bring about an Open Protocol initiative, which calls for T1D technologies to work together regardless of the manufacturer. Breakthrough T1D has worked with the FDA to build understanding of Open Protocol and the need for FDA support in ensuring that safely compatible technologies are made available to the T1D community.
ADA Standards of Care: Recommendation for CGM Use in Pregnancy
Breakthrough T1D Research Area: Glucose Control
The United States has joined Australia and the United Kingdom in recommending that CGMs may be used to improve HbA1c outcomes in pregnant women with T1D.
Breakthrough T1D Leadership: Breakthrough T1D funded the CONCEPTT trial, which stands for Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial. The clinical trial showed that using a CGM during and prior to pregnancy improves the health outcomes for both mothers and babies and reduces cost for neonatal hospitalization, an otherwise frequent occurrence. It was the CONCEPTT trial that made the ADA revise their recommendations.
Enabling Coverage, Affordability and Choice
Breakthrough T1D Research Area: Advocacy
Aaron J. Kowalski, Ph.D., gave a heartening and stirring presentation on insulin affordability, as part of the ADA’s session on Making Insulin Affordable. One in four people are rationing insulin, which is “unacceptable,” Kowalski said. “We need systemic changes.” He proposed key changes, including eliminating rebates and keeping co-pays consistent throughout the year. “The companies need to do more,” he said, such as providing free or low-cost insulin to people who need it, like the uninsured or underinsured. “No one,” said Kowalski, “should suffer or die because they can’t access insulin.”
Breakthrough T1D Leadership: Breakthrough T1D’s advocacy promotes regulatory policies supporting access to insulin and other therapies and technologies. Breakthrough T1D amplifies voices of the T1D community, advocating for pre-existing condition protection, to make out-of-pocket costs predictable and reasonable and to give people access to all life-saving technology, through our #Coverage2Control initiative.
There’s More Than Just Genetics
Breakthrough T1D Research Area: Complications
There’s epigenetics. It’s a layer on top of genetics, and it is altered by the environment. It affects gene expression, and influences behavior and disease. For people with diabetes, though, it can lead to complications. Rama Natarajan, Ph.D., of the City of Hope, introduced the idea of “metabolic memory,” in which the complications are determined by one’s glucose levels over time. If you remain in control of your glucose levels, your “metabolic memory” helps lower your risk of complications over your lifetime. If you’re in poor control, your risk for complications is greater because there is not a baseline of success to fall back on. TXNIP, a protein that is upregulated in beta cell stress, is highly associated with complications, making it a good target for therapies to reduce the risk.
Breakthrough T1D Leadership: Natarajan has received six grants from Breakthrough T1D since 2000, the latter of which was profiling epigenetic approaches to T1D. More recently, Natarajan received a grant from the Breakthrough T1D-supported Special Diabetes Program at the NIH, for his follow-up research on epigenetics of complications from the milestone clinical trial that demonstrated that intensive insulin therapy can decrease, sometimes vastly, the risk of complications.
Impaired Awareness of Hypoglycemia
Breakthrough T1D Research Area: Glucose Control/Complications
Impaired awareness of hypoglycemia (very low blood sugar) affects approximately 20% to 25% of all people with T1D and is a major risk factor for severe hypoglycemia, in which you need someone else to treat you. Breakthrough T1D-funded researcher Dr. Rory McCrimmon wanted to see if high-intensity training would help people with T1D who had impaired awareness. They recruited 12 participants, and found that a single episode of high-intensity exercise led to a 30% increase in hypoglycemic awareness. High-intensity exercise, therefore, could represent a novel therapy for people with impaired awareness of hypoglycemia.
Breakthrough T1D Leadership: Dr. McCrimmon has received Breakthrough T1D funding since 2002, when he was an early career scientist at Yale University. Since then, he has been funded by six grants from Breakthrough T1D, while at the University of Dundee in Scotland.
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