In the last two months, the diabetes community has witnessed something new: a major campaign encouraging people to get screened for the antibodies that cause type 1 diabetes.
It’s called the “1 Pledge” movement. The campaign is brought to you by Sanofi, familiar to people with diabetes as one of the big three insulin manufacturers. Flashing slogans like “Take the Pledge” and “Screen It Like You Mean It,” 1 Pledge is blanketing social media with ads, leveraging connections with celebrities (like Usher, who has a child with type 1 diabetes) and throwing parties in Times Square to help spread the word on type 1 diabetes screening.
What is Type 1 Diabetes Screening?
It’s possible to identify type 1 diabetes long before it causes health issues. Proactively screening for autoantibodies can alert people ahead of time that they are slowly developing the disease.
“It’s not very well understood that type 1 diabetes is actually an autoimmune condition that starts many years before the clinical diagnosis,” says Luigi Meneghini, MD, Sanofi’s vice president & US medical head of diabetes.
Experts delineate three stages of type 1 diabetes development:
- Stage 1: Islet cell autoimmunity, characterized by the presence of autoantibodies. During this stage, blood sugar levels are still normal and the patient experiences no symptoms.
- Stage 2: Early beta cell destruction. The decrease in beta cell mass reduces insulin production and results in slightly elevated blood glucose levels. The patient will still not experience any symptoms.
- Stage 3: Full-blown type 1 diabetes. At this stage, beta cell mass is so low that the patient will experience overt hyperglycemia accompanied by the clinical symptoms of diabetes. Treatment with exogenous insulin will soon become necessary.
The first and second stages of type 1 diabetes development have no obvious symptoms. They can only be discovered by testing proactively — that is, by screening.
What’s the Point of Type 1 Diabetes Screening?
“The big advantage here is that the risk of presenting with diabetic ketoacidosis (DKA) drops,” says Dr. Meneghini.
DKA is extremely dangerous for patients (and, not to mention, expensive for hospitals and insurers). And DKA is not just a traumatic experience in the moment — it also appears to have negative long-term health effects: “When you present in DKA, you tend to have higher blood sugars over the long term and an increased risk of complications. There are neurocognitive implications as well,” says Meneghini. People who avoid DKA during diagnosis usually have better long-term outcomes.
Today, about 40 percent of American children are diagnosed with type 1 diabetes only after developing DKA.
“This is 2024,” says Meneghini. “It is absolutely unacceptable that people end up in the hospital with diabetic ketoacidosis when there are plenty of resources to prevent this from happening. There’s no reason that anyone should be left behind.”
Even patients not on a collision course with DKA could benefit from learning that they were likely to develop type 1 diabetes.
“The ability to prepare for the eventuality of needing to manage with insulin is really important. If you knew two or three years in advance [that you would develop type 1 diabetes], you and your family could much better prepare to manage type 1 diabetes, which is not an easy task,” says Nadia Fontaine, the general manager of Sanofi’s US type 1 diabetes franchise.
Such foreknowledge gives patients time to learn about diabetes and the elements of diabetes treatment, such as carbohydrate counting, thus ensuring a far smoother and less stressful transition once they need to begin insulin therapy.
Screening and Tzield
In promoting screening, Sanofi also has what you might call an ulterior motive. The conglomerate recently acquired the drug teplizumab (Tzield), the only drug approved by the FDA to treat people for an early stage of type 1 diabetes. To put it simply, large screening efforts will increase the number of potential Tzield customers.
When given to patients known to carry the antibodies that cause type 1 diabetes, Tzield delays the onset of symptoms by an average of nearly three years. For some lucky users, the benefits may be even longer-lasting. Some of the volunteers for the drug’s earliest trials were found to be diabetes-free eight years after the initial treatment.
Tzield, though, is astonishingly expensive. The drug is reportedly listed at $13,850 per vial. At 14 vials per treatment, that’s a full sticker price of $193,900. Presumably, this extraordinary cost limits treatment to only those lucky enough to have great wealth or marvelous health insurance.
For some, this may make the 1 Pledge campaign seem a little crass. But despite Sanofi’s clear vested financial interest, there is no question that the 1 Pledge effort can also benefit people without the means to use Tzield.
Should We Be Screening Everyone for Type 1 Diabetes Antibodies?
If you have type 1 diabetes, it is overwhelmingly likely that you were never offered any type of screening before your diagnosis. Health systems do not automatically offer screening for type 1 diabetes risks, and doctors rarely recommend the practice. Sanofi is trying to change that with the 1 Pledge campaign.
“We need to change the way it’s being looked at by the medical community, really encouraging and educating around screening because both the doctors and the patients are not very familiar with the idea,” says Fontaine. “Our goal is educating and creating awareness, getting to a point where more people are proactively screening and more physicians are recommending screening.”
New data has caused some experts to now believe that we should be routinely screening all American children for type 1 diabetes risk.
Two pilot programs, one in Colorado and one in Germany, have shown the potential of universal screening. In Germany, the Fr1da study found that only 0.29 percent of Bavarian children aged 2-5 had antibodies indicating an early stage of type 1 diabetes. But when these children later developed type 1 diabetes, almost none of them experienced DKA. In Colorado, the ASK screening campaign has delivered similar results, cutting DKA rates to a tiny fraction of its normal prevalence.
Who Should Be Screened for Type 1 Diabetes?
The people that benefit most obviously from screening are those with the greatest probability of developing type 1 diabetes: youth with a family history of the condition.
“If you’re a first-degree relative of someone with type 1 diabetes, your risk goes from 0.5% to 5-6%,” says Meneghini. “It’s not an enormous risk, but it’s a substantial risk.”
In response to Tzield’s approval, the latest edition of the American Diabetes Association’s Standards of Care has included new recommendations regarding type 1 diabetes screening: “Relatives of youth with type 1 diabetes should be offered testing for islet autoantibodies.”
And yet, as Fontaine explains, “Anyone can be at risk. We know that 85% of people with type 1 don’t have a family history.” And Meneghini points out that “most people diagnosed with t1d are actually adults.” Meneghini also suggests that people with other autoimmune conditions, such as Hashimoto’s disease or celiac, are at an elevated risk of type 1 diabetes.
In short, it may make sense to cast a wide net, which is why 1 Pledge is recommending everyone to arrange for a screening.
How Can People Get Screened?
The 1 Pledge website recommends three options for type 1 diabetes screening:
- Talk to your doctor directly. They may be able to administer a test in your office or refer you to a local lab, and ideally can help with insurance coverage for the test.
- Order a test from TrialNet, an important initiative that uses your results to help advance our understanding of type 1 diabetes. TrialNet’s testing is free for relatives of people with type 1 diabetes.
- Purchase a test from Enable Biosciences. These tests may need to be confirmed with a lab test.
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