JDRF has launched a first-of-its-kind program aimed at early detection of type 1 diabetes (T1D), built around an easy to use at-home test kit.
Given that most T1D diagnoses are dramatic affairs that land many children and adults in the hospital — sometimes with near-death experiences — and a large majority of newly diagnosed have no warning or family history of this chronic condition, a test kit like this could be a gamechanger.
For example, Tom Webb in South Carolina vividly remembers the nightmare of being diagnosed with T1D when he was 7 years old, as his family was moving to a different state.
Without any history of diabetes in the family, the rapid-onset symptoms seemed to come out of nowhere: constantly needing to use the bathroom and extreme thirst, and an overwhelming sense of fatigue. Being so young and en route to a new state, Webb says he had no idea what was happening to his body at the time.
“We moved on a Friday and I went to the doctor on Monday. I don’t know what my blood sugar was, but I was in DKA (diabetes ketoacidosis),” he recalls. “I’m lucky I didn’t end up in a coma or anything.”
Had early T1D screening been available, Webb says his family might have had some idea of the warning signs before he ended up in the emergency room.
For Webb and so many others who’ve been suddenly thrown into the deep end of life with diabetes, this new program offers hope.
“T1Detect is the first and only screening program that will enable a broad population to know their risk of T1D,” says JDRF CEO Dr. Aaron Kowalski, who lives with the illness himself. “This groundbreaking initiative is an important milestone for JDRF because it will increase awareness about early-stage T1D, provide access to crucial education and support for those at risk, and pave the way to ensuring that T1D screening becomes part of universal, clinical preventive services.”
T1Detect is a blood test done by finger prick, similar to traditional fingerstick blood sugar checks. It uses an autoantibody detection panel (ADAP), one of the best ways to detect the most important T1D markers.
The way it works is that you register your information online and order the home kit from manufacturer Enable Biosciences for a price of $55. JDRF is also subsidizing it for those who might not be able to afford the full cost, at a discount price of just $10.
Enable ships the at-home testing kit within a few days.
When it arrives, use the included lancet to do a finger poke and add the blood sample to several little circles on the enclosed card before sending it back to the company by mail to process the results.
Enable will confirm receipt by email and begin processing the sample. Full results can take 4 to 6 weeks, along with a full explanation of what those results mean and your next steps.
JDRF states on its site that “JDRF-funded scientists have discovered that having two or more specific autoantibodies — antibodies that are directed toward your own body or, in the case of T1D, your pancreas — means that you have an almost 100-percent chance of developing T1D.”
Since Enable Biosciences is conducting the screening and collecting the data, it will hold the data for all participants and is governed by existing laws like HIPAA (Health Insurance Portability and Accountability Act). By clicking (or unclicking) a box on the registration site, you can opt-in or out to allow your results to also be shared with JDRF for future research.
“In the future, we may make de-identified data available to members of the T1D research community for certain purposes,” JDRF explains to DiabetesMine.
JDRF is also working with other companies and groups to promote and implement this new screening program:
- MedIQ, a healthcare consulting and education service based in Baltimore, MD, will provide clinician education.
- Nuvera Life Science Consulting in New Jersey will advise on program design and operations.
- California-based non-profit org Beyond Type 1 (BT1), through its JDRF alliance, will provide community support, education, and awareness to patients through the online community.
- Individual donors and corporate sponsors of JDRF are also supporting this, including founding sponsor Provention Bio, a New Jersey-based biopharmaceutical company focused on intercepting and preventing autoimmune diseases.
How does this relate to TrialNet?
Many may be familiar with TrialNet, the global T1D screening research collaboration JDRF has supported since the early 2000s. That program is aimed at families in which one or more members have been diagnosed with T1D and explores the possible hereditary connections.
This new initiative, on the other hand, widens the reach of early screening to those who have no family history of T1D.
“The biggest difference between the programs is that the JDRF T1Detect program does not have any eligibility requirements or age restrictions,” a JDRF spokesperson tells DiabetesMine.
TrialNet’s eligibility requirements limit participation to those with a relative with T1D: ages 2.5 to 45 for those with a parent, child, or sibling already diagnosed, and ages 2.5 to 20 for an expanded list of family members including grandparents, aunts/uncles, and more.
“We need to address that gap,” JDRF says. “There is a great need to increase screening for T1D risk and this program provides a different model for doing that, in a community setting, that adds to and complements existing screening programs, like TrialNet.”
If someone tests positive for T1D using T1Detect, they will be immediately directed to follow up with TrialNet and similar programs to explore clinical trials and other support efforts.
DiabetesMine asked both JDRF and BT1 about awareness and education aimed at family doctors, primary care physicians, community centers, and lower-income hotspots where this early screening could make the most difference for the general population.
Sarah Noel, JDRF’s vice president of community engagement and strategic alliances, says they’ll launch education for healthcare professionals starting in February 2021. It’s part of a long-term strategy to promote T1D risk-screening as part of primary clinical preventive care, she says.
She says educational materials will include email briefs, a live webinar, and online learning modules on a variety of topics, including:
- the importance of talking to families and parents about T1D screening and risk for children
- stages of T1D and preventing DKA
- investigational therapies to slow T1D progression becoming available in clinical settings
- the risks associated with misdiagnosis
“This education will be promoted and available to primary care providers, endocrinologists, pediatricians, pediatric endocrinologists, nurse practitioners, physicians’ assistants, diabetes care and education specialists, nurses and pharmacists, and those caring for underserved communities,” Noel tells DiabetesMine.
Beyond Type 1 adds that it is “working on a wide variety of things to support T1Detect, both digital and physical, and targeted to a wide variety of audiences.”
The benefits of early screening for T1D are undisputed and becoming more clear, especially given the fact that
A 2015 clinical study from the TrialNet network confirms that 75 percent of people who have two or more diabetes-related autoantibodies and abnormal blood sugar levels will go on to become insulin-dependent within 5 years.
With those stats in mind and the fact that 40 percent of the newly diagnosed T1Ds present DKA symptoms at the time of diagnosis, it’s no wonder that early screening is an appealing thought. A variety of studies around the world are already proving that pre-screening for T1D can save lives.
“Screening will decrease but not prevent DKA completely,” says Dr. Anette-Gabriele Ziegler, lead study author and director of the Institute of Diabetes Research at Helmholtz Zentrum München in Germany. “Apart from the cases that are missed because they are too young or they have a very rapid progression to clinical disease, there are also some families who will not change how they behave when their child is given a pre-diagnosis.”
And what can be done to halt T1D if early screening shows it’s developing?
A second trial involving the drug anti-thymocyte globulin (ATG), which is typically used for preventing kidney transplant rejection, also showed similar positive effects in slowing down or stopping disease progression.
Above all, this new T1Detect option presents hope.
In Massachusetts, Sara Weiss recalls how undiagnosed diabetes led to DKA symptoms and the death of her 9-year-old son, Jordan. That was in January 2003, after Weiss had tried to convince local medical professionals to see her son for the extreme thirst, bed-wetting, weight loss, and lethargy that they’d been noticing. An urgent nurse brushed off those warnings signs and his vomiting as the flu and told Weiss to monitor his symptoms rather than see the child.
Jordan died the next morning in his sleep.
“You have to know what to look for in advance of those more severe symptoms and DKA because those alarm bells can’t go off when someone has flu symptoms,” she says. “Maybe an early screening test can raise awareness if those warning signs appear.”
Indiana D-Mom Hope Burton remembers the horror of when her teenage son was hospitalized in DKA during a school band trip to Disney World in his senior year in 2014. The family flew to Florida, terrified after hearing the news, and they drove back after two days of being inundated with new diabetes information. With only a 5-minute lesson at the hospital, Burton says they were unprepared for that new normal.
“It was a nightmare,” she tells DiabetesMine. “There is no one blood-related on either side of our family who has it, so screening wasn’t in our minds and the diagnosis came out of leftfield. I’m not sure what an early screening might have done, but it does offer a sense of hope for those without any family connection. Maybe it would’ve changed this scary, unexpected T1D introduction for us.”
The same goes for Lizzie McKenzie in Missouri, who was diagnosed unexpectedly at age 28 when she went to the doctor for bronchitis. She had been feeling poorly for a couple of months with classic symptoms: peeing frequently, losing weight, and sleeping constantly.
But it wasn’t until blood work following her in-person visit that the truth became known: “emergency level diabetes,” just short of DKA.
At diagnosis, she learned that her A1C level was dangerously high at 11 percent. No one else in her family lives with the condition.
She was extremely lucky not to have experienced DKA or fallen unconscious.
“Catching it early (by chance) saved my life, but I think it’s a great idea to have early screening. It would have helped a lot for me,” she says.