A new initiative launched by the diabetes charity JDRF aims to broaden screening for type 1 diabetes risk for the general population of the United States.
Called T1Detect, the program involves ordering a home fingerstick blood test for type 1 diabetes–associated autoantibodies and sending the sample to a laboratory. Individuals who are found to be at high risk will be provided with further education and guidance and the opportunity to join a clinical trial.
The test costs $55, but for those with financial hardship, JDRF will charge just $10. The organization is planning a public awareness campaign as well as a clinician education program via MedIQ.
Among the program’s sponsors is Provention Bio, manufacturer of the monoclonal antibody teplizumab, which has been shown to delay the onset of type 1 diabetes for people at high risk by a median of 3 years. Teplizumab is currently under review by the US Food and Drug Administration as a breakthrough therapy for the prevention type 1 diabetes. A decision expected in 2021. Other such agents are in development.
There are several benefits to screening for type 1 diabetes even before therapeutic interventions become available, Sanjoy Dutta, PhD, JDRF associate vice president of research and institutional partnerships, told Medscape Medical News.
“Screening for risk of T1D is extremely important because even though we don’t yet have an approved therapy to delay progression of the disease, we know that screening has its benefits, including reducing [diabetic ketoacidosis] at diagnosis [by increasing awareness] and giving families time to prepare for a disease that’s 24/7 and could last a lifetime until we have a cure,” he stessed.
For Most Who Develop Type 1 Diabetes, Family Members Are Not Affected
The teplizumab study was conducted through the TrialNet program, which for the past 20 years has been screening close family members of people with type 1 diabetes. Such individuals are on average at 15-fold increased risk of developing the condition. For about 85% of people who develop type 1 diabetes, family members are not affected.
People who might want to take advantage of T1Detect include family members of people with type 1 diabetes who don’t qualify for TrialNet because of age (ie, being older than 45 years; half of new-onset type 1 diabetes cases occur in adults); those who were screened in TrialNet years ago but tested negative (second screenings aren’t provided); people with other autoimmune conditions, which often co-occur with type 1 diabetes; or anyone who is interested in knowing their status.
Ultimate Aim Is Universal Screening
Ultimately, Dutta said, the aim is to gather cost-effectiveness data in order to convince payers to reimburse for universal type 1 diabetes screening. One such program that was conducted among German schoolchildren was shown to be feasible.
“We want this to be covered by healthcare systems in the US and around the world, just like you screen for heart disease risk with LDL cholesterol or for [cancers] with markers in the blood, with some done routinely at certain age groups…but we don’t have the cost-effectiveness data buttoned up yet,” Dutta said.
The test, conducted by Enable Biosciences, screens for three of the four type 1 diabetes–associated autoantibodies that are included in standard laboratory tests (insulin autoantibodies, glutamic acid decarboxylase autoantibodies, and insulinoma-associated-2 autoantibodies, but not zinc transporter-8 autoantibodies).
Testing positive for two or more of those confers a 75% increased risk for type 1 diabetes at 5 years and a nearly 100% lifetime risk.
It’s not yet clear at what age universal screening would be optimal, or how often.
Early data suggest that autoantibody levels peak at ages 2–3 and 6–8 years among children who eventually develop type 1 diabetes, but some data suggest there’s another peak at ages 11–13 years.
Importantly, Dutta noted, “there are no adult data. JDRF would love to have a TrialNet or [German study] equivalent in adults. No one is looking at it systematically.”
Dutta is an employee of JDRF.