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| Check out our new website! |
TrialNet is excited to announce the launch of our new website www.trialnet.org.
The site has a fresh new look and was designed with you in mind. User-friendly navigation provides easy access to our research, more information about T1D, the stages of T1D (see article in this issue), our families, all you've ever wanted to know about TrialNet, and how you can participate.
Here are a few ways you can use the website to join the conversation and get involved: |
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Add your family's TrialNet story and join our growing community of #T1D families on the Pathway to Prevention |
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Sign up for screening through the Pathway to Prevention study |
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Complete an online consent form |
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Find a location near you |
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Find answers to your questions–or ask us! |
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| We welcome your feedback, so let us know if there's something you'd like to see or if you have suggestions for improvement. Take a look for yourself today at www.trialnet.org. |
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| RESEARCH SPOTLIGHT |
Type 1 diabetes staging classification opens door
for intervention |
| For most people, the onset of type 1 diabetes seems to occur suddenly, often resulting in a trip to the emergency room with life-threatening complications such as diabetic ketoacidosis (DKA). TrialNet is working to change that scenario. |
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In Diabetes Care, the JDRF, American Diabetes Association (ADA), and Endocrine Society recommended adoption of a new type 1 diabetes staging classification.
This recommendation is largely based on two decades of TrialNet research involving more than 160,000 relatives of people with type 1 diabetes.
Type 1 diabetes can now be most accurately understood as a disease that progresses in three distinct stages.
STAGE 1 is the start of type 1 diabetes. Individuals test positive for two or more diabetes-related autoantibodies. The immune system has already begun attacking the insulin-producing beta cells, although there are no symptoms and blood sugar remains normal. Learn more ›
STAGE 2, like stage 1, includes individuals who have two or more diabetes-related autoantibodies, but now, blood sugar levels have become abnormal due to increasing loss of beta cells. There are still no symptoms. Learn more › |
| For both stages 1 and 2, lifetime risk of developing type 1 diabetes approaches 100 percent. |
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STAGE 3 is when clinical diagnosis typically takes place. By this time, there is significant beta cell loss and individuals generally show common symptoms of type 1 diabetes, which include frequent urination, excessive thirst, weight loss, and fatigue. Learn more ›
The new staging classification is vital to understanding how type 1 progresses. Equally important is TrialNet's ability to diagnose the disease in its earliest stages, allowing for prompt intervention.
According to TrialNet Chair Carla Greenbaum, MD, "Identification of the presymptomatic stages of type 1 diabetes can be compared to identification of high blood pressure as a predictor of heart attack and stroke. Before treatment for high blood pressure became commonplace, we were missing a key tool to prevent heart disease. Today, people can receive intervention long before they experience symptoms or significant complications."
Clinical research supports the usefulness of diagnosing type 1 diabetes early–before beta cell loss advances to stage 3. The earlier diagnosis is made in the disease process, the sooner intervention can take place, and the more beta cells are likely to remain. More beta cells may lead to better outcomes regarding blood sugar control and reduction of long-term complications. |
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"TrialNet's goal is to identify the disease at its earliest stage, delay progression, and ultimately prevent it. We offer screening and clinical trials for every stage of type 1 diabetes and close monitoring for disease progression," explains Dr. Greenbaum. |
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For people who participate in type 1 diabetes prevention research like TrialNet, the risk of DKA at diagnosis decreases from 30 percent to less than 4 percent.
Both the ADA and JDRF recommend TrialNet screening for people who have relatives with type 1 diabetes. Family members have a 15 times greater risk of being diagnosed than someone with no family history. Screening is available at no charge to: |
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Anyone between the ages of 1 and 45 with a sibling, child or parent with type 1 diabetes. |
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Anyone between the ages of 1 and 20 with a sibling, child, parent, cousin, uncle, aunt, niece, nephew, grandparent, or half-sibling with type 1 diabetes. |
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| It is recommended that children who do not test positive for diabetes-related auto-antibodies continue to get rescreened every year until age 18. |
| There are more than 200 TrialNet screening sites worldwide. Screening test kits are also available by mail. Learn more at trialnet.org. |
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| RESEARCH SPOTLIGHT |
Study illustrates important role of participants
in placebo arm of TrialNet studies |
| In a two-year study wrapping up at year's end, frozen blood samples from previous TrialNet study participants who did not receive the study drug played a starring role. |
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| TrialNet Co-Principal Investigator Alice Long, PhD, at BRI in Seattle, Washington, is part of a team of researchers using frozen blood samples from previous TrialNet study participants to learn more about immune pathways in type 1 diabetes. |
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Most research trials have two arms–a treatment group and a control group. The treatment group gets the study drug, while the control group gets a placebo (looks like the study drug but has no active ingredient). A computer randomly assigns participants to one of these groups. No one knows who is in which group –not even the study staff–until the end of the study.
This study, "Defining immunological markers of B-cell decline during the first two years post T1D onset," relied on frozen blood samples from 48 participants in the control of three trials (Abatacept, Rituxamab, and MMF/DZB) that spanned a 12-year period. All three trials were for people newly diagnosed with type 1 diabetes and required participants to start the study within 100 days of diagnosis. |
| "Samples from a range of people at different stages of disease are incredibly useful, enabling us to better understand disease progression," explains Co-Principal Investigator Alice Long, PhD. "The preserved samples from a clinical trial provide a much more consistent and clinically defined population." |
For this study, Long and her colleagues examined the blood samples from the same participants at four different time points–start of the trial, 1 month, 1 year, and 18 months–exploring change over time. "Some people lose C-Peptide quickly, others slowly," says Dr. Long. "We want to know why–what's changing and what's going on immunologically." C-Peptide indicates the number of remaining beta cells, and consequently, the body's ability to keep making insulin.
Typically, a research study addresses just one question. What makes this study unique is three different researchers with individual expertise are studying the samples to try to answer different questions and then put together their findings. Type 1 diabetes may rely on immune interactions, and this is the first study to address that by looking at different immune pathways on the same samples.
Dr. Long at Benaroya Research Institute at Virginia Mason (BRI) in Seattle, Washington, is studying B-cells and regulatory T-cells (what they look like). Jeffrey Bluestone, PhD, Co-Principal Investigator, is looking at regulatory T-cells (how well they function) at University of California San Francisco. From Kings College in London, Mark Peakman, PhD, Lead Principal Investigator and TrialNet Director of Ancillary Studies, is focusing on CD8 T-cells, known to exclusively attack pancreatic islets. |
| "We are working as a team, making every effort to get all the information we can," states Dr. Peakman. "We chose to look at each one of these cells because we know they are ones that change with long-standing type 1 diabetes. Going in collectively, we increase our odds of seeing correlations between slow and fast progressors (rate of beta cell decline)." |
| Having completed their experiments, researchers are now doing individual analysis. Next, they will review the "unblinded" results together and try to answer additional questions. Be sure to watch for study results in an upcoming issue of this newsletter. |
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| PARTICIPANT SPOTLIGHT |
Bristol area teen first in UK to participate in
Abatacept Prevention Study |
| Elliot, a 17-year-old from a small village outside Bristol, recently completed treatment in the Abatacept Prevention Study. He is the first person in the United Kingdom (UK) to do so. |
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| Elliot and father, happy to be on the forefront of T1D research, pictured here with Pediatric Research Nurse Nicki Thorne (left), and Diabetes Research Nurse Sue Crouch. |
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The Abatacept Prevention Study is exploring the drug's usefulness in slowing or preventing progression of early stage type 1 diabetes. In an earlier TrialNet study for people newly diagnosed, those who took abatacept showed 59% higher insulin production and prolonged insulin production. The hope is that that starting the treatment earlier–before clinical diagnosis–will produce even better results.
Elliot was 8 years old when he and his two brothers were first screened by TrialNet. His father, Paul, learned about screening from Elliot's grandmother, who developed T1D in her mid-20s. She received a letter from the British Diabetic Association inviting relatives of people with T1D to get screened by TrialNet. While Elliot's brothers were negative for the autoantibodies that signal the early stages of T1D, Elliot tested positive for one.
Paul recalls, "We were invited to TrialNet's Bristol site for monitoring Elliot's health, and we've participated ever since, going in twice a year for testing. Over the years, he tested positive for additional diabetes-related autoantibodies. Then, in the summer of 2015, we learned that Elliot was eligible for the Abatacept Prevention Study at Musgrove Park Hospital in Taunton, which was convenient for us."
Elliot says, "The first visit was a little scary, but the doctors and nurses were very kind, and the whole experience was absolutely fine. Taunton was flexible with my school schedule, and it all worked out very well. " |
| He adds, "Some people hate the idea of needles and IVs. But if you're willing and fine with needles, and your schedule permits, it's a good thing to do." |
| The treatment phase of the study includes three IV infusions in the first four weeks (every other week), then one infusion monthly for 11 months. Elliot is now in the follow-up phase of the study, returning to Taunton twice a year for tests and monitoring. He won't know whether he received the study drug or the placebo (looks like the study drug but is inactive) until the end of the study. |
| "It's quite cool being on the forefront of T1D research and being able to help," says Elliot. "The feeling that my sitting in a chair for 2 hours every now and again could help someone is quite nice." |
"Elliot is very modest," says Musgrove's Diabetes Research Nurse, Sue Crouch. "It's a huge commitment for a young participant to take on. Our goal was to deliver the most positive experience possible, and I think we were able to do just that."
Sue hopes to use Elliot's testimonial as the first in a pool of testimonials that could be shared with prospective study participants throughout the UK.
Congratulations to Elliot, his family, and his TrialNet team for helping lead the way in this important research! |
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| Clinical Center SPOTLIGHT |
TrialNet Strong: The Hospital for Sick Children,
Toronto, Canada |
| With 11 participating locations spanning 4,600 miles, The Hospital for Sick Children, also known as SickKids, leads TrialNet's thriving program in Canada. |
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| Hospital for Sick Children TrialNet team members Bianca Perro (left) and Lesley Eisel prepare to screen attendees at last year's Guelph JDRF Walk. |
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| Diane Wherrett, M.D., has led the Canadian Clinical Center since TrialNet's start in 1994. Most recently, she was appointed Study Chair for the Pathway to Prevention Study. |
| "Being part of TrialNet has been one of the most rewarding parts of my career," says Dr. Wherrett. "The research is fascinating, and working with my colleagues and our TrialNet participants is fantastic." |
According to Hospital for Sick Children Research Nurse Lesley Eisel, community outreach is a major focus. "Each year, we screen 500-600 people at screening events across Ontario. We are very grateful for all the families throughout Canada who participate in this important research."
The JDRF Walk is the biggest screening event of the year, and TrialNet locations across the country provide wide coverage. "JDRF Walk events offer relatives of people with type 1 diabetes a great opportunity to get screened for the early stages of the disease," explains Lesley. |
| You can reach the TrialNet team at the Hospital for Sick Children (SickKids) at 1-866-699-1899 or [email protected] |
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TrialNet sites throughout Canada |
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Vancouver, BC – BC Children's Hospital |
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Calgary, AB – Alberta Children's Hospital |
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Edmonton, AB – Stollery Children's Hospital |
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Winnipeg, MB – Health Sciences Centre Winnipeg |
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London, ON – Children's Hospital at London Health Sciences Centre |
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Hamilton, ON – Hamilton Health Sciences/McMaster Children's
Hospital |
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Ottawa, ON – Children's Hospital of Eastern Ontario |
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Montreal, QC – Montreal Children's Hospital |
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Halifax, NS – IWK Health Centre |
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St. John's, NFLD – Janeway Child Health & Rehabilitation Centre |
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Saskatoon, SK – University of Saskatchewan |
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| New & Noteworthy |
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Beyond Type 1: Clinical Trials & the Type 1 Diabetes
Cure |
| Stephen Gitelman, MD, TrialNet Principal Investigator at the University of California San Francisco explains type 1 diabetes disease progression and how TrialNet is attempting to halt progression in family members at risk. http://bit.ly/2reGvVT |
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| Pushkin the Therapy Dog |
| Introducing Pushkin: Naomie Berrie Diabetes Center in New York City recently hired an 8 pound Russian Bolonka therapy dog. According to TrialNet Study Coordinator, Cecilia Uche, "He is the best with our TrialNet participants. He really keeps many of them calm and distracted during blood draws!" http://bit.ly/2mAT3ol |
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| Inside Your Health: Type 1 Diabetes |
| Jennifer McVean, MD, TrialNet Investigator at University of Minnesota, was on 5 Eyewitness News to talk about TrialNet's advances in T1D research http://bit.ly/2ossean |
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JDRF One Walks, TypeOneNation Summits, and
Diabetes Camps |
| JDRF events and Diabetes Camps are a convenient way to get screened through TrialNet. To find out if TrialNet will be at an event near you, contact TrialNet at [email protected] |
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| Share your TrialNet story! |
| Add your family's TrialNet story to our new website and join our growing community of #T1D families on the Pathway to Prevention. Add your family's story here |
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| Trialnet Screening |
| TrialNet risk screening is accessible and convenient |
| Type 1 risk screening is available at more than 200 TrialNet locations in the United States, Canada, United Kingdom, Italy, Sweden, Finland, Germany, Australia, and New Zealand. |
| You can find a TrialNet screening location or request a test kit by visiting www.trialnet.org/participate. TrialNet risk screening is available at no charge to those who are: |
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Age 1-45 who have a parent, sibling or child with
type 1 diabetes, or… |
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Age 1-20 who have a niece, nephew, aunt, uncle,
grandparent, half-sibling, or cousin with type 1 diabetes. |
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| Trialnet Studies |
| Studies currently enrolling |
| Pathway to Prevention |
| If you have a relative with T1D, you're in a unique position to help us learn more about the disease and how to stop it. The first step is to sign up for Pathway to Prevention screening to determine your risk of developing T1D. Learn more › |
| Monitoring |
| If your screening results show that you have one or more diabetes-related autoantibodies, and there's not a prevention study that's right for you at this time, you can opt in for monitoring and make a lasting contribution to T1D research. You'll be closely monitored by experts at the forefront of T1D research. Learn more › |
| CTLA4-lg (Abatacept) Prevention Trial |
| Exploring whether a drug called abatacept can help delay or prevent onset of type 1 diabetes. Abatacept has shown potential in preserving insulin production in people newly diagnosed with type 1 diabetes. Learn more › |
| LIFT (Long-Term Investigative Follow-up in TrialNet) Study |
| Monitoring long-term progress of participants from the Pathway to Prevention Study or prevention studies who have developed type 1 diabetes, or participants from new-onset studies that have ended. Learn more › |
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