ABOUT AUTOIMMUNE
TYPE 1 DIABETES

Catching and impacting type 1 diabetes early starts with learning

Will, TZIELD Patient
Will, a TZIELD® (teplizumab-mzwv) patient, running outdoors

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There's a lot to say about type 1 diabetes (T1D) and TZIELD. If you'd prefer a more bite-sized view of T1D, including understanding how to spot T1D early, the importance of early screening and if TZIELD is right for you or your loved one, check out our TZIELD Essentials page!

EXPLORE

WHAT IS TYPE 1 DIABETES

Although many think of type 1 diabetes (T1D) as a disease that mostly affects children, it’s actually a lifelong progressive autoimmune disease that can happen to anyone, regardless of their age, family history, or lifestyle choices.

Autoimmune type 1 diabetes and the body

With type 1 diabetes, your immune system mistakenly attacks and damages healthy insulin-producing cells called beta cells. Insulin helps convert food to energy in the body. Without insulin, blood sugar levels become too high, which can lead to life-threatening complications such as diabetic ketoacidosis (DKA).

There are 3 stages of autoimmune type 1 diabetes. In Stages 1 and 2, people don't have any obvious symptoms. But Stage 3, the final stage, is different. This is when type 1 diabetes can severely impact both your body and day-to-day life. That’s because at this point, too many insulin-producing beta cells have been damaged for the body to make enough insulin. This is when lifestyle changes and insulin injections become necessary.

62%

Reports show that 62% of new T1D diagnoses occur after the age of 20

Two lightning bolts with a no symbol over it

Type 1 diabetes has
no noticeable symptoms in early stages

Katie, a TZIELD® (teplizumab-mzwv) patient, playing soccer with her young daughter and son outdoorsKatie, TZIELD patient with family

Autoantibodies and type 1 diabetes

Autoimmune type 1 diabetes starts long before people need insulin injections or notice symptoms, and before the silently growing risk of life-threatening complications like DKA. But even during the early stages, signals show up in the blood in the form of type 1 diabetes–related proteins called autoantibodies.

Autoantibodies are the key to early detection 

Importantly, autoantibodies can be detected with a blood test, allowing for earlier diagnosis of autoimmune type 1 diabetes and proactive planning to do something about it before an unexpected diagnosis or potentially being blindsided by serious complications.

Key words to remember:

  • Beta cells
    Beta cells

    Beta cells are the cells in the pancreas that are responsible for making insulin and releasing it into the body to control blood sugar.

  • Autoantibodies
    Autoantibodies

    Type 1 diabetes autoantibodies are proteins that show up as markers in the blood when the immune system attacks insulin-making beta cells. They are an early warning that there’s a significant risk of autoimmune type 1 diabetes and insulin dependence in the future. These autoantibodies can be screened for with a blood test that is different from a blood sugar level test.

UNDERSTANDING THE STAGES OF AUTOIMMUNE TYPE 1 DIABETES

TZIELD is used to delay the onset of Stage 3 autoimmune type 1 diabetes for people 8 years and older with Stage 2 autoimmune type 1 diabetes. But what, exactly, do Stages 2 and 3 mean when it comes to autoimmune type 1 diabetes?

Autoimmune type 1 diabetes develops in 3 stages

As you've learned, Stages 1 and 2 of autoimmune type 1 diabetes have no obvious symptoms because the body is still able to make enough insulin. However, in Stage 3, the body is no longer able to make enough insulin to keep blood sugar at a normal level. This is when symptoms are noticed, serious complications can happen, and insulin injections and disease management may become necessary.

TYPE 1 DIABETES STAGES

  • Stage 1
    • Normal beta cellsThe immune system has started attacking beta cells
    • AutoantibodiesTwo or more type 1 diabetes autoantibodies are present
    • Normal blood sugar levelsBlood sugar levels are
      within a normal range
    • Two lightning bolts with a no symbol over it No obvious symptoms
    • A pancreas that does not need insulinNo insulin is needed
  • Stage 2
    • Attacked beta cellsBeta cells continue to be attacked
    • AutoantibodiesTwo or more type 1 diabetes autoantibodies are present
    • Outside of normal blood sugar levelsBlood sugar levels may be outside of a normal range.
      This is called dysglycemia.
    • Two lightning bolts with a no symbol over it No obvious symptoms
    • A pancreas that does not need insulinNo insulin is needed
  • Stage 3
    • Damaged beta cellsBeta cells are damaged and can’t make enough insulin to regulate blood sugar
    • AutoantibodiesTwo or more type 1 diabetes autoantibodies may be present
    • Higher than normal blood sugar levelsBlood sugar levels are higher than a healthy range (hyperglycemia) and there is a risk of dangerous complications like diabetic ketoacidosis (DKA)
    • Two lightning boltsObvious symptoms
    • A pancreas that cannot make enough insulin on its ownThe body can’t make
      enough insulin on its own,
      so insulin injections will eventually be needed

A warning exclamation point DKA can come without warning

Diabetic ketoacidosis, or DKA, is a serious complication of autoimmune type 1 diabetes that can happen when the blood becomes acidic as a result of not having enough insulin in the body.

DKA can come without warning, and coma and even death can result from it. DKA could also have lasting effects on brain function that lead to lower verbal IQ and memory problems. Studies also show that a DKA event can affect the body’s ability to regulate blood sugar even years after.

Early screening and more time to learn how to manage autoimmune type 1 diabetes could help you or a loved one lower the risk of DKA!

There are no data to suggest that TZIELD will have any effect on these outcomes.

Amanda: Two kids with T1D

Amanda was devastated to learn her daughter had type 1 diabetes. But thanks to proactive screening, she was able to help make an impact on her son's outcome.

Amanda is an Ambassador sponsored by Sanofi.

Video transcript

TZIELD indication card
Amanda VO:
“We are being compensated by Sanofi to share our story.”

Amanda, TZIELD Caregiver
[Compensated by Sanofi]
“In 2020, we noticed that our daughter Jenna had become increasingly lethargic. Sleeping late, going to bed early, napping. She had also been extremely thirsty. We kept digging on our own and discovered that type 1 diabetes was a possibility for her. So, we did purchase a glucometer. We tested her blood sugar, and she was 565.”

“So, we went to the emergency room, where she was admitted to the ICU and that started our journey with type 1 diabetes. I learned that you are up to 15 times more likely to have type 1 diabetes if you have a direct family relative, and that was very concerning to us.”

“We learned that our son tested positive for multiple autoantibodies. We also learned that he had abnormal blood glucose levels, which indicated positivity for Stage 2 of type 1 diabetes. To me, there is absolutely no disadvantage to knowing. Knowledge is power.”

See Amanda’s full story on the Real Talk About Type 1 & TZIELD page

[TZIELD logo]

What is TZIELD?
TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body can’t make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 8 years 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.

It is not known if TZIELD is safe and effective in children under 8 years of age.

IMPORTANT SAFETY INFORMATION

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

TZIELD may cause serious side effects. These include:

  • Cytokine release syndrome (CRS). Signs and symptoms may start during the first 5 days of TZIELD treatment and could include fever, nausea, 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 your liver 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 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 a serious infection or an infection that does not go away or keeps coming back
  • have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your doctor that you are receiving 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
  • 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:

  • rash
  • leukopenia (decrease in white blood cell counts)
  • headache

These are not all of the possible side effects of TZIELD. Talk to your healthcare provider for more information, and tell them about any side effects you notice. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see [accompanying] Medication Guide and Prescribing Information.

MAT-US-2306423-v2.0-01/2024

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SEE ALLSEE LESS
IMPORTANT SAFETY INFORMATION What is the most important information I should know about TZIELD? TZIELD may cause serious side effects. These include:
  • Cytokine release syndrome (CRS). Signs and symptoms may start during the first 5 days of TZIELD treatment and could include fever, nausea, 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 your liver 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 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 a serious infection or an infection that does not go away or keeps coming back
  • have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your doctor that you are receiving 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
  • 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:
  • rash
  • leukopenia (decrease in white blood cell counts)
  • headache

These are not all of the possible side effects of TZIELD. Talk to your healthcare provider for more information, and tell them about any side effects you notice. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Medication Guide and Prescribing Information.

What is TZIELD?

TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body can’t make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 8 years 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.

It is not known if TZIELD is safe and effective in children under 8 years of age.

IMPORTANT SAFETY INFORMATION AND APPROVED USE

What is the most important information I should know about TZIELD? TZIELD may cause serious side effects. These include:
  • Cytokine release syndrome (CRS). Signs and symptoms may start during the first 5 days of TZIELD treatment and could include fever, nausea, 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 your liver 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 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 a serious infection or an infection that does not go away or keeps coming back
  • have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your doctor that you are receiving 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
  • 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:
  • rash
  • leukopenia (decrease in white blood cell counts)
  • headache

These are not all of the possible side effects of TZIELD. Talk to your healthcare provider for more information, and tell them about any side effects you notice. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Medication Guide and Prescribing Information.

What is TZIELD?

TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body can’t make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 8 years 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.

It is not known if TZIELD is safe and effective in children under 8 years of age.