About autoimmune type 1 diabetes
Managing type 1 diabetes is no longer just about waiting until you experience symptoms. It's possible to stay ahead of what's next.
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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!
ExploreWhat is type 1 diabetes?
Type 1 diabetes is a lifelong, progressive autoimmune disease. Anyone at any age can develop T1D, though some are at higher risk.
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.
of new T1D diagnoses occur after the age of 20
T1D often has no visible signs or symptoms in its early stages.
Autoantibodies and type 1 diabetes
As many as 62% of people are unaware that they have type 1 diabetes until they experience an emergency that requires hospitalization. But even during the disease's early stages, signals show up in the blood in the form of type 1 diabetes–related proteins called autoantibodies.
*TZIELD is for people 8 years and older who have Stage 2 type 1 diabetes.
Autoantibodies are key to early detection
Autoantibody (AAb) screening, a test that is not included in annual blood work, offers the opportunity to identify, monitor and potentially treat autoimmune T1D before symptoms appear.
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.
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
Autoimmune type 1 diabetes develops in 3 stages
Stage 1
No insulin is needed
No obvious symptoms
The immune system has started attacking beta cells
Two or more type 1 diabetes autoantibodies are present
Blood sugar levels are within a normal range
Stage 2
No insulin is needed
No obvious symptoms
Beta cells continue to be attacked
Two or more type 1 diabetes autoantibodies are present
Blood sugar levels may be outside of a normal range. This is called dysglycemia
Stage 3
The body can’t make enough insulin on its own, so insulin injections will eventually be needed
Obvious symptoms
Beta cells are damaged and can’t make enough insulin to regulate blood sugar
Two or more type 1 diabetes autoantibodies are present
Blood sugar levels are higher than a healthy range (hyperglycemia) and there is a risk of dangerous complications like diabetic ketoacidosis (DKA)
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.
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
- 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.