Just a Few Drops Makes a Big Difference
Research Spotlight

TrialNet highlights research advances during Diabetes Awareness Month and World Diabetes Day

Each November, we join the diabetes community to recognize Diabetes Awareness Month and World Diabetes Day on November 14th. This year, as TrialNet begins to celebrate 20 years, we share major research advances made possible by our incredible study participants and research teams around the world.
Identifying early stages of T1D
More than 200,000 relatives of people with T1D have taken part in TrialNet risk screening. Besides learning their personal risk, they played an important role in helping identify the early stages of T1D. Because it promotes earlier disease identification and provides opportunity for intervention, staging classification was recommended for adoption by the JDRF, American Diabetes Association (ADA), and Endocrine Society in 2016.
Early T1D identification—prior to symptoms—is extremely useful. The earlier in the disease process someone is diagnosed, the more beta cells likely remain. And this gives us the opportunity to slow or stop further destruction, preventing type 1 diabetes.  In addition, for people participating in T1D research including close monitoring, risk of diabetic ketoacidosis (DKA), a serious and sometimes life-threatening condition, decreases from 30% to 3%.

Advances in T1D prevention
In 2019, TrialNet’s Teplizumab Prevention Study made headlines as the first to delay T1D onset for 2 or more years in high risk individuals.
Teplizumab is an immunotherapy drug that interferes with the body’s destruction of its own beta cells. While previous studies showed teplizumab could prolong insulin production in people recently diagnosed, this was the first study to prolong insulin production in people at high risk. 

According to findings, median time for people in the control group to develop clinical diabetes was just over 24 months while the treatment group averaged 48 months before progressing to diagnosis. See more details here.
Participants electing to continue being followed are being tested every 6 months, so researchers can continue to track changes.
Also in 2019, findings from TrialNet’s ATG/GCSF New Onset Study reported low-dose thymoglobulin (ATG) preserved insulin production and improved long-term blood sugar control for 2 years in people newly diagnosed with type 1 diabetes. Hemoglobin A1c levels were significantly lower in those treated with low-dose ATG, as compared to placebo. See more details here.
In 2017, TrialNet reported findings from the Oral Insulin Prevention Study, our largest study ever with more than 500 participants. TrialNet tested oral insulin in a daily pill to see if it could delay or prevent T1D from progressing from stage 1 to stage 2, ultimately preventing clinical diagnosis in those at risk (stage 3). 
While oral insulin did not prevent or delay T1D in the majority of participants, it did delay onset an average of 31 months in a sub-group of 55 people, supporting our understanding that not everyone develops T1D in the same way. See more details here.
Current prevention studies
TrialNet is currently conducting two prevention studies testing immune therapies:
Hydroxychloroquine (HCQ) Prevention Study - now enrolling
TrialNet is testing the drug hydroxychloroquine (HCQ) to see if it can delay or prevent early stage T1D (stage 1) from progressing to abnormal glucose tolerance (stage 2), and clinical diagnosis (stage 3). HCQ is already used to reduce symptoms and progression of other autoimmune diseases, such as rheumatoid arthritis and lupus. This is the first study to see if it can prevent or delay T1D. Learn more here.
Abatacept Prevention Study – no longer enrolling
TrialNet is testing the drug abatacept to see if it can delay or prevent progression of early stage T1D (stage 1 or stage 2), to clinical diagnosis (stage 3). In earlier studies of people newly diagnosed (stage 3), abatacept helped slow down disease progression. We should know in the next year if this drug is also effective in delaying T1D progression in pre-diagnosed people. Learn more here.
Impact for people living with T1D
The work TrialNet is doing to try to control the immune system in early stages of T1D has the potential to directly benefit people who have been living with T1D for a long time.
“Even if we could give someone with T1D new insulin producing cells, we would still need a way to keep the immune system from attacking them,” explains Dr. Greenbaum. “All the drugs shown to be effective in slowing T1D progression are immune therapy drugs. This clearly tells us it’s the immune system we need to keep under control.”
What’s next?

With a several studies in the pipeline, we aim to answer questions including these:
Now that we have evidence that immunotherapies can slow disease progression, which drugs or combination of drugs work best at what stage?
If we treat at an even earlier stage, can we delay the disease even longer?
People living with T1D

Later this year, we’ll be launching a phase 1 study for people diagnosed with T1D within the past 4 years. This brand new therapy is being tested for safety and tolerability. If this study results in no safety concerns, we plan to conduct a larger study to see if this same treatment can slow down or stop T1D in people at an earlier stage of disease, before clinical diagnosis. 
“Every time we do a study, we learn something about the benefits and risks of the therapy, but we also learn more about the disease,” explains TrialNet Chair Carla Greenbaum, M.D. “We know that not everyone responds to the same treatment in the same way. Our goal is to eventually be able to match the exact therapy to the needs of individual participants.”
A few drops can make a big difference!

TrialNet T1D risk screening looks for type 1 diabetes years before it appears. Know you or your child’s risk for T1D with a free blood test delivered to your door.
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The future without T1D begins with you!
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