By the time Jaime Lucove was in her late 20s and hoping to start a family, she worried about the likelihood of her children developing type 1 diabetes (T1D), which she has lived with since she was a young child. When she became pregnant, Lucove and her then-husband, who doesn’t have diabetes, met with a high-risk obstetrician, and they were relieved to learn that the risk was low. 

Soon after, Lucove remembers learning from a Facebook discussion group about diabetes screening with TrialNet. At first, she wasn’t convinced it made sense “because there was nothing you could do if the results were positive,” she remembers thinking.    

She had two healthy kids, a boy, Carter, in 2009, and a girl, Ashley, in 2012. Lucove was confident she would notice any symptoms of T1D early enough to avoid diabetes-related ketoacidosis (DKA), a dangerous and potentially life-threatening condition that children often face at diagnosis. Lucove thought she knew enough after a lifetime with diabetes to keep them safe, if any signs emerged. “So,” she said, “we didn’t screen.”  

For the better part of a decade, there was no reason to worry. 

Then the world of diabetes research shifted with the approval of Tzield® (teplizumab), an immunotherapy drug produced by Provention Bio (later acquired by Sanofi), in 2022. It was the first, and still only, FDA-approved therapy to delay the onset of T1D in those 8 years of age and older who have Stage 2 T1D. This means that they’ve tested positive for two or more diabetes-related autoantibodies, have abnormal glucose levels, and are asymptomatic. In studies, it was found to delay the condition’s full development for an average of two years.   

Lucove, now 42, an epidemiologist and Senior Director of Real-World Evidence at T1D Exchange, remembered when she first saw the notice on her LinkedIn feed and was amazed. With that news, her calculations shifted. It was no longer the case that there was “nothing to do” with early screening results. Now, there was a way to potentially give back time and keep the condition at bay, albeit temporarily, during crucial childhood years. “That’s when,” she recalled, “we decided to screen the kids.” 

 

Approaching screening 

The family’s path to screening — and the eventual discovery that Carter, then 14, would be a candidate for this new drug and share a T1D diagnosis with his mother — was not straightforward. The reality is that family health decisions and logistics are complicated and can carry emotional burdens, resulting in delays, avoidance, and mishaps.   

Lucove ordered the screening tests from TrialNet in the fall of 2023 and then promptly stored them away in her closet, unprepared to face the potential they contained.  

“They just sort of sat there,” she recalled. “I don’t know. There’s some mental block. If it’s positive, you don’t want to know. It’s very strange because I had decided to want to know.” But instead, she waited. 

A few months later, over a long holiday weekend in January 2024, searching for an activity, Lucove decided to finally give her kids the test. “I saw it in the closet,” she remembered. “‘OK, I guess we’ll clean out the closet, and it’s time to do the test.’” 

That’s when the mishap came into play. Ashley went first. Sitting at the dining room table, Lucove opened the screening packages and took her time to do it correctly. She remembered it took a while, but finally, she got the blood sample and put it in the vial as directed. She realized, too late, she had mixed up the tubes and put Ashley’s blood sample in the tube marked for Carter. She said, “I knew the study wouldn’t accept them.” She threw away the ruined tests, frustrated to be back at square one, needing to order more tests. 

After hesitating for so long, it felt too hard to wait for new tests. “I just wanted to know if their blood sugar was normal,” she remembers. “I just wanted some assurance.” So, she brought out her glucometer, and they sat again at the table while the kids held out their fingers. Ashley’s reading was in the normal range, around 90. Then she took Carter’s and was surprised to see a reading of 150 mg/dl pop up.  

“‘Wow,’ I thought, ‘that’s a little bit strange,’” she said. She looked up the guidelines and saw that a post-meal reading should be less than 140 mg/dl. She hoped it was an error or a meaningless variation, but it was enough to unleash a wave of worry. She had to wait for a doctor’s opinion when the office opened after the long weekend. The next morning, she tested his blood sugar again so she could get a fasting reading. It was in the 120s.  

“Oh, no,” Lucove then remembers thinking.  

The doctor ordered a hemoglobin A1C test, which came back at 6.4, confirming, on average, higher-than-normal glucose levels, which Lucove feared. The doctor then ordered antibody testing for Carter, which also returned positive.  

Her son’s diagnosis triggered overwhelming feelings of upset and stress, which Lucove characterized as a “total breakdown” that caught her by surprise. While she wanted the screening because there was action she could take to protect her children, now that she knew the answer, and it wasn’t what she had hoped for, she was flooded by sadness. Part of it was understanding that Carter had seen his Mom deal with her diabetes all his life and was fully aware of what a T1D diagnosis meant.  

Carter was also upset with the news and the changes in his life that would happen moving forward. “I felt so sad,” she explained. “Diabetes is a condition that you can’t ever turn off. It’s with you every minute of the day and affects many decisions.” 

She knew that diabetes treatment had significantly advanced since she was diagnosed — the breakthrough of Tzield was one such example — and Carter would be growing up in a different diabetes era. But still, his life would be changed by this.  

“I know that if people manage their diabetes well, they can live a full life and do everything they want,” she said. “I don’t think it’s a limiting disease in that way. But it’s always a mental burden to have that following you around. So that’s what my sadness was about.”  

 

Getting Tzield: cost, coverage, access  

Lucove knew Tzield was available, but she had no idea how to get it or how difficult it might be. She called her insurance company with trepidation. “I knew the drug was very expensive,” she said.   

The 14-day treatment of Tzield carried a price tag of $193,900. Depending on the coverage plan, some insurance companies cover the infusions with co-pays. Sanofi, which acquired Provention Bio in 2023, has an education and access assistance plan, called Compass, with the aim of expanding the availability and affordability of the drug. Lucove suspected that it would be a fight to get the new wonder drug covered and approved for Carter — and she was right.  

Carter’s health plan was a restrictive HMO, and Lucove was frustrated that none of their local Southern California hospitals administered Tzield. They would have to get an out-of-network referral. After weeks of navigating obstacles, more testing, and pushing through barriers, they finally obtained authorization at a medical center a short flight away. Lucove detailed more about the long road to getting the drug for Carter on the Juicebox podcast. 

Lucove’s medical training as an epidemiologist was functional in wading through the research. She wanted to know everything about the drug she was considering for her son. Her biggest concern was the small risk of something called cytokine release syndrome. It happens when the body’s immune response acts more aggressively than it should in reaction to certain drugs. 

“It’s very serious, but it happened very rarely in the trial. And that’s why they do blood work during the infusion to monitor certain levels,” Lucove said. “So, is it risky? In a small percentage of cases, there’s a bad outcome. Some people hear about that and say, ‘It’s not worth it.’” 

In the end, Lucove thought the decision should be up to Carter. “He’s 14, smart and quantitative in how he thinks about things. I wanted him to understand all the data. I explained the trial to him. I said, on average, it’ll be two years if you don’t get the treatment, but if you get it, on average, it’s four—but it might not work,” said Lucove. “I felt like he needed to understand all of that.”  

They talked it over for a while. “So, what do you think?” she asked. “Do you want to do it?” 

He nodded. “It’s worth a shot,” he replied.  

“Yes, it’s worth a shot,” Lucove agreed.  

During the two-week stay for the procedure, mother and son spent each morning at the hospital for the infusions and lab work. Some days were longer than others, but they generally had the afternoons to themselves.  

“That was 14 days in a row, just me-and-him time,” Lucove said. “When do you get that type of time with your teenager? It was cool, like a vacation. I took the time off from work. We played poker daily during the infusion, and he beat me every time. We went to museums in the afternoons and on a couple of hikes. We also talked about diabetes.”