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In many ways, Kathleen Karnes, a clinical specialist living in Knoxville, Tenn., is like most moms. She worries about scraped knees and missed homework; wonders whether her kids are sleeping enough or growing up too fast; and lies awake thinking about what the future might hold. 

But as a mom living with type 1 diabetes (T1D), Kathleen also carries a different kind of worry as well. She knows how unpredictable the disease can be, and how much vigilance it demands. Kathleen’s own diagnosis gave her an awareness that many parents don’t have; that family history of T1D could increase her children’s risk of developing the disease. 

“I was terrified that my daughters, Ava and Ella Rose, were at risk of developing T1D and felt a deep sense of guilt about passing this burden onto them,” shares Kathleen. With these worries top of mind, Kathleen decided that she wanted to be as informed as possible, so she would be ready if either of her children were ever diagnosed. 

When fears become reality 

Understanding the value of early risk detection, Kathleen knew the first step would be to get her daughters screened for T1D-related autoantibodies, which show your risk for developing T1D. 

“A few weeks later, I received a dreaded phone call that no mother wants to receive from her doctor, confirming that my daughter Ella Rose tested positive for multiple T1D-related autoantibodies,” Kathleen explains. Follow-up blood testing confirmed that Ella Rose was diagnosed in Stage 1 T1D, which, while asymptomatic, has a nearly 100 percent lifetime risk of progressing to Stage 3 of the disease. 

“I was in shock. Even though I always knew it was a possibility, I felt paralyzed by the thought of simply watching and waiting for my daughter to progress to insulin-dependent Stage 3 T1D,” Kathleen shares.

With uncertainty hanging over her, Kathleen closely followed advancements in the T1D space, “As a mom, all I could do was hold onto hope and believe that advancements may come along that could change things for Ella Rose.” 

Then, one morning, years later, it did.

A day that changed everything 

A few years after her daughter’s early-stage T1D diagnosis, Kathleen was watching TV when a news segment aired that stopped her in her tracks. It was covering TZIELD^® (teplizumab-mzwv) injection 2mg/2mL — a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body cannot make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 1 year of age and older who have Stage 2 type 1 diabetes. This means that they have tested positive for 2 or more type 1 diabetes-related autoantibodies, have abnormal blood sugar levels, and do not have type 2 diabetes or other forms of diabetes. It is not known if TZIELD is safe and effective in children under 1 years of age. 

Interestingly, while Ella Rose would not have been eligible for TZIELD when she was first diagnosed at 2 years old, the Food and Drug Administration recently expanded the age indication from 8 years old to as young as 1 year old — opening a new chapter in diabetes care for young children.

“As someone who lives with this disease every day, and understands the impacts of day-to-day management, I immediately understood what the opportunity to delay insulin-dependent T1D could mean for my daughter,” recalls Kathleen. “So, when I saw that segment, I couldn’t have picked up the phone fast enough.” 

Kathleen contacted her family’s health care team to rescreen Ella Rose, who was 9 at the time, to evaluate whether her T1D progressed to the next stage. After follow-up blood sugar testing, her blood sugar became abnormal and revealed Ella Rose had progressed to Stage 2 T1D, which placed her in the window for treatment with TZIELD.

“The silver lining of Ella Rose’s Stage 2 T1D diagnosis was that it motivated us to get serious about the situation,” shares Kathleen. “Together with our doctor, we decided that TZIELD was the right option for Ella Rose and decided to move forward with the infusion process.”

TZIELD may cause serious side effects, including potentially life-threatening cases of viral reactivation including Epstein-Barr virus (EBV) and cytomegalovirus (CMV), Cytokine Release Syndrome and a decrease in white blood cell counts which can affect your body’s ability to fight infections. The most common side effects seen with TZIELD include decrease in white blood cells, vomiting, rash, diarrhea and headache. These are not all of the possible side effects you can experience with TZIELD. Keep reading for the full Important Safety Information. 

One mother’s message

Today, 11-year-old Ella Rose is thriving. She fills her days with basketball, gymnastics, and cheerleading, and — thanks to her mother’s early action — learning about eventual T1D management with daily insulin injections.

“If I had a message for other moms, it would be this: don’t wait,” says Kathleen. “Talk to your doctor about risk factors like family history, screening options, and whether TZIELD may be an option. Early action can make a difference.”

Kathleen knows she can’t rewrite her own T1D diagnosis or erase the fear of passing this burden onto her daughter. But by staying informed, she did something meaningful — she changed the story for her daughter. By choosing to face her fears and act early, she gave Ella Rose something every parent of a child with Stage 2 T1D hopes for: the chance for more time before progressing to Stage 3 of the disease.

Kathleen is a TZIELD Brand Ambassador.

What is TZIELD?

TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body cannot make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 1 year of age and older who have Stage 2 type 1 diabetes. This means that they have tested positive for 2 or more type 1 diabetes-related autoantibodies, have abnormal blood sugar levels, and do not have type 2 diabetes or other forms of diabetes. 

It is not known if TZIELD is safe and effective in children under 1 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TZIELD?

TZIELD may cause serious side effects, including:

• Viral Reactivation. Epstein-Barr virus (EBV) and cytomegalovirus (CMV) are common viruses that may stay inactive in your body after an initial infection. TZIELD may cause these viruses to become active again which, especially in patients with a weakened immune system, can become serious and potentially life-threatening. These viral reactivations can happen during treatment with TZIELD and up to 2 months after your last dose. Your healthcare provider will test you for active EBV and CMV infections before treatment with TZIELD. Contact your healthcare provider right away if you develop symptoms of an infection during or after treatment with TZIELD (such as fever, swollen glands, or fatigue). 
• Cytokine release syndrome (CRS). Signs and symptoms may start during the first 5 days of TZIELD treatment and could include fever, nausea (with or without vomiting), feeling tired (fatigue), headache, muscle and joint pain, or increased liver enzymes in your blood. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD. 
• Decrease in white blood cells. TZIELD may cause a decrease in a type of white blood cell called lymphocytes. A decrease in white blood cells is a serious, but common side effect that can affect your body’s ability to fight infections. A decrease in white blood cell counts can happen after your first dose. Your white blood cell counts will start to go back to normal after your fifth dose of TZIELD. Some people may develop longer and more severe decreases in lymphocytes.

Your healthcare provider will do blood tests to check for active infections, verify your liver function and your complete blood counts before you start treatment and during treatment with TZIELD. During and after your treatment with TZIELD, your healthcare provider will check for serious side effects, as well as other side effects, and treat you as needed. Your healthcare provider may temporarily or completely stop your treatment with TZIELD, if you develop liver problems, have a serious infection or viral reactivation, or if your blood counts stay too low.

What should I tell my healthcare provider before receiving TZIELD? 

Before or after receiving TZIELD, tell your healthcare provider about all your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section “What is the most important information I should know about TZIELD?”
• have a weakened immune system, including if you have Down syndrome.
• have a serious infection or an infection that does not go away or keeps coming back (chronic). 
• have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with TZIELD before receiving a vaccine.
• are pregnant or plan to become pregnant. TZIELD may harm your unborn baby. Do not receive TZIELD during pregnancy and at least 30 days before a planned pregnancy. 
  If you become pregnant while taking TZIELD, you are encouraged to report your pregnancy to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi.
• are breastfeeding or plan to breastfeed. It is not known if TZIELD passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive TZIELD.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of TZIELD? 

The most common side effects of TZIELD include: 

• decrease in white blood cell counts

• vomiting 

• rash 

• diarrhea

• headache 

These are not all of the possible side effects of TZIELD. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to us at 1-800-633-1610 or visit https://ae.reporting.sanofi.

Please see full Prescribing Information, including Risk of SERIOUS SIDE EFFECTS and Medication Guide.