Minnesota boy one of first to receive new diabetes treatment

Sanford Health offers Tzield, which can delay the onset of type 1 stage 3 diabetes

11-year-old boy raises his hand excitedly to show off his chalkboard countdown of Tzield diabetes treatments.

For the 14th straight day, Joseph Rubash is headed to a hospital room at Sanford Bemidji. He is an 11-year-old boy who brightens the day of every person who comes in contact with him.

“He’s a real loving boy,” said Brenda Rubash, Joseph’s mother. “He loves to hug and tell us that he loves us, and he’s really gregarious and outgoing.”

The dark cloud of diabetes

Joseph is also at stage 2 of type 1 diabetes, meaning he does not yet need insulin, but his blood sugar levels are abnormal. Joseph is just the second patient in the entire country to be treated with a brand new drug called teplizumab (Tzield), which became FDA-approved at the end of 2022.

“This drug is not for people who need insulin. If you need insulin, you have (clinical stage 3) diabetes. And this drug is not for someone who has diabetes yet,” said Luis Casas, M.D., Joseph’s pediatric endocrinologist at Sanford Health.

Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that make insulin. People with a type 1 diabetes diagnosis have increased glucose that requires insulin shots (or wearing an insulin pump) to survive and must check their blood sugar levels regularly throughout the day.

Although it can appear at any age, type 1 diabetes is usually diagnosed in children and young adults. A person is at higher risk for type 1 diabetes if they have a parent, brother or sister with type 1 diabetes, although most patients with type 1 diabetes do not have a family history.

In announcing its approval of the drug, the U.S. Food and Drug Administration said Tzield binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.

Joseph’s parents have always known their son may develop diabetes. Joseph’s father, Joe Rubash, is a nurse practitioner at Sanford’s clinic in Walker, Minnesota. He also has type 1 diabetes himself, and has an insulin pump to help regulate his blood sugar. Joseph was not eligible for clinical trials due to his Down syndrome, so the Rubash family could only hope for an approved drug. When Dr. Casas called about Tzield, they jumped at the opportunity.

“Every day without insulin, every day without having a high blood sugar, low blood sugar or hooked up to the pump is a gift,” said Joe.

“It was just an amazing thought to think that Joseph might be eligible for that type of medicine,” said Brenda. “Dr. Casas was such a strong advocate for Joseph to receive this medication and was just all on board and all excited about the possibility he could have it.”

Breakthrough treatment

In a clinical trial, teplizumab kept type 1 stage 2 patients from developing stage 3 diabetes for an average of a little more than two and a half years. This would keep Joseph from needing insulin, but it could also buy enough time for future scientific breakthroughs as well.

“The future is full of hope,” said Brenda. “When we look at something like Tzield, we never imagined that would be possible. We hoped for it, but now there’s an intervention. We can do something potentially to delay that onset. And who knows in that two years what’s going to happen? What’ll be developed next to maybe further protect those cells?”

The Rubash family hopes other parents will screen their children for antibodies as well. Sanford Health offers screenings for T1D and celiac antibodies through the Sanford PLEDGE study. Children from ages 0-5, or from 9-16 are eligible to be screened as part of routine care at Sanford clinics. In addition, children aged 6-17 qualify for screening if they have a sibling with type 1 diabetes or T1D antibodies.

“We’re encouraging early screening because that’s really how you know you’re in stage 2,” said Brenda Rubash. “It’s a simple blood test to see if those autoimmune antibodies are present, and then if they follow-up, it can be monitored so they don’t end up with diabetic ketoacidosis.”

Diabetic ketoacidosis is a serious complication of diabetes that occurs when the body can no longer produce enough insulin.

See Sanford’s diabetes research: PLEDGE Pediatric Screening Study

The family is also incredibly thankful that they were able to come to Sanford Bemidji for treatment, which is just a half hour away from their home in Walker, Minnesota.

“We’re not flying to Baltimore, we’re not driving to Rochester, we’re not having to go to Fargo. It’s right here in Bemidji,” said Joe.

“That whole stress was just relieved, where we could focus on helping Joseph get through the process and stay home,” said Brenda. “To be able to go home at night and sleep in your own bed, I mean, that’s best for the patient.

‘A pioneer’

Joseph spent most of this day smiling and chatting with his nurses. He gave them letters thanking them for their help, and big hugs too. He also got a new stuffed otter and some balloons to celebrate his final treatment.

Thanks to the efforts of doctors, nurses, pharmacists and so many others across the Sanford Health system, Joseph also has the gift of time. And now he’s at the vanguard of a brand new treatment as well.

“He is a pioneer,” said Dr. Casas. “Hopefully if we can delay it enough to one day have a treatment, you know, that’s gonna be our holy grail.”

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Posted In Bemidji, Children's, Endocrinology, Here for all. Here for good., Research