Skip to Main Content

Proactive screening & monitoring

Early screening can help identify at-risk patients before symptoms arise.1

A young girl smiling while being pushed on a swing by her friend outdoors
A young girl smiling while being pushed on a swing by her friend outdoors

ADA Standards of Care recommendation: proactively screen at-risk patients for these 4 islet AAbs1*

A GADA autoantibody
A GADA autoantibody

GADA

Glutamic acid decarboxylase 65 AAb

GADA

Glutamic acid decarboxylase 65 AAb

An IAA autoantibody
An IAA autoantibody

IAA

Insulin
AAb

IAA

Insulin AAb

An IA-2A autoantibody
An IA-2A autoantibody

IA-2A

Insulinoma-associated antigen 2 AAb

IA-2A

Insulinoma-associated antigen 2 AAb

A ZnT8A autoantibody
A ZnT8A autoantibody

ZnT8A

Zinc
transporter-8
AAb

ZnT8A

Zinc transporter-8 AAb

According to the ADA Standards of Care, IA-2 AAb is an independent risk factor for T1D progression.1

*Islet cell AAb (ICA) is also available for testing.2

AAb=autoantibody; ADA=American Diabetes Association.

When tested together, these 4 AAbs have been found to have a 98% autoimmunity detection rate at disease onset.3

What screening and monitoring can mean for your patients:

A warning exclamation point

Screening for
AAbs and close monitoring can help reduce DKA risk at diagnosis in children by ~88%4

A checklist and a writing utensil

~40% of adults
over the age of 30 with T1D are initially
diagnosed with
T2D1,5

Two arrows going in the same direction and crossing in the middle

Identifying TZIELD-eligible patients in presymptomatic Stage 2 T1D6

A dollar sign

The average cost to screen for 1 AAb is ~$12 while most patients pay up to $48 for all 4 
AAb screening tests†

Tips to help avoid higher costs for your patients:

  • Review the correct ICD-9/ICD-10 billing codes
  • Confirm labs are in-network
  • Advise patients to confirm costs with their insurance, especially when navigating high deductibles or testing early in the yearly insurance cycle

Costs for AAb screening vary by health plan, benefit design, and test. Please check with the health plan to confirm costs for patients.

†n=15,000. Analysis has been conducted using LAAD Medical and Remittance data from May 2023 to April 2024. Includes commercial claims with one of the following current procedural technology (CPT) codes: 86341 and/or 86337. Note: the analysis does not differentiate between the number of AAbs tested within each claim.7

Screening and monitoring guide for patients‡

Adult patients1,2,6,8

Initially screen for T1D risk during yearly visits to help improve feasibility§​
For those at an increased risk:
  • Rescreen in 1 year

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

  • Conduct confirmatory tests
  • Monitor for AAbs and glycemic status (HbA1c, RBG):
    • Those at an increased risk, monitor annually
    • All others, screen every 3 years

Please refer to the ADA Standards of Care for further guidance about patients who have tested positive for 1 AAb.

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

Stage 1
    • Repeat HbA1c annually
      • Adjust frequency according to individual risk
      • If HbA1c changes by ≥10%, perform OGTT to stage
      • If normoglycemic for 5 years, reduce metabolic monitoring to every 2 years
Stage 2
  • Monitor every 6 months using HbA1c and one of the following:
    • Blinded CGM
    • Higher frequency SMBG
    • 2-hour plasma glucose following OGTT
  • If HbA1c changes by ≥10%, perform OGTT to stage

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

ADA Standards of Care recommendation: 



Patients with 2+ AAbs should be referred to a specialist for metabolic staging, education, and consider­ation of prevention trials or approved treatments like TZIELD.1,6

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

For those at an increased risk:
  • Rescreen in 1 year

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

  • Conduct confirmatory tests
  • Monitor for AAbs and glycemic status (HbA1c, RBG):
    • Those at an increased risk, monitor annually
    • All others, screen every 3 years

Please refer to the ADA Standards of Care for further guidance about patients who have tested positive for 1 AAb.

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

Stage 1
    • Repeat HbA1c annually
      • Adjust frequency according to individual risk
      • If HbA1c changes by ≥10%, perform OGTT to stage
      • If normoglycemic for 5 years, reduce metabolic monitoring to every 2 years
Stage 2
  • Monitor every 6 months using HbA1c and one of the following:
    • Blinded CGM
    • Higher frequency SMBG
    • 2-hour plasma glucose following OGTT
  • If HbA1c changes by ≥10%, perform OGTT to stage

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

ADA Standards of Care recommendation: 



Patients with 2+ AAbs should be referred to a specialist for metabolic staging, education, and consider­ation of prevention trials or approved treatments like TZIELD.1,6

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

Pediatric patients1,2,4,6,8

Screen during recommended well-child visits (1-2 years, 4-6 years, and 11-13 years)§​
For those at an increased risk:
  • Rescreen in 1 year
All others:
  • Rescreen around 6 years and between 9-11 years of age
Screening for islet AAbs and close monitoring can reduce DKA risk in children by ~88%.4

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

  • Consider collaborating with a specialist
  • Conduct confirmatory tests
  • Monitor for AAbs and glycemic status (HbA1c, RBG):
    • If <3 years of age: every 6 months for 3 years, then annually for 3 more years
    • If ≥3 years of age: annually for 3 years
  • If there's no more progression, stop screening and metabolic monitoring
Screening for islet AAbs and close monitoring can reduce DKA risk in children by ~88%.5

Please refer to the ADA Standards of Care for further guidance about patients who have tested positive for 1 AAb.

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

Stage 1
  • Repeat HbA1c with RBG or 10- to 14-day CGM:
    • <3 years of age: every 3 months
    • 3-9 years of age: every 6 months
    • >9 years of age: annually
  • To diagnose progression to Stage 2 or Stage 3, use OGTT or a 2-hour blood glucose test
Stage 2
    • Monitor glycemic status every 3 months
    • Consider treatment options
Screening for islet AAbs and close monitoring can reduce DKA risk at diagnosis in children by ~88%.5

ADA Standards of Care recommendation: 



Patients with 2+ AAbs should be referred to a specialist for metabolic staging, education, and consider­ation of prevention trials or approved treatments like TZIELD.1,6

TZIELD is for eligible stage 2 T1D patients 1 year of age and older.6

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

For those at an increased risk:
  • Rescreen in 1 year
All others:
  • Rescreen around 6 years and between 9-11 years of age
Screening for islet AAbs and close monitoring can reduce DKA risk in children by ~88%.4

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

  • Consider collaborating with a specialist
  • Conduct confirmatory tests
  • Monitor for AAbs and glycemic status (HbA1c, RBG):
    • If <3 years of age: every 6 months for 3 years, then annually for 3 more years
    • If ≥3 years of age: annually for 3 years
  • If there's no more progression, stop screening and metabolic monitoring
Screening for islet AAbs and close monitoring can reduce DKA risk in children by ~88%.5

Please refer to the ADA Standards of Care for further guidance about patients who have tested positive for 1 AAb.

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

Stage 1
  • Repeat HbA1c with RBG or 10- to 14-day CGM:
    • <3 years of age: every 3 months
    • 3-9 years of age: every 6 months
    • >9 years of age: annually
  • To diagnose progression to Stage 2 or Stage 3, use OGTT or a 2-hour blood glucose test
Stage 2
    • Monitor glycemic status every 3 months
    • Consider treatment options
Screening for islet AAbs and close monitoring can reduce DKA risk at diagnosis in children by ~88%.5

ADA Standards of Care recommendation: 



Patients with 2+ AAbs should be referred to a specialist for metabolic staging, education, and consider­ation of prevention trials or approved treatments like TZIELD.1,6

TZIELD is for eligible stage 2 T1D patients 1 year of age and older.6

‡The full consensus monitoring guidance recommends metabolic monitoring via the following methods: HbA1c, OGTT, and RBG, plus SMBG at home.2

§Please refer to the full consensus monitoring guidance led by Breakthrough T1D (formerly JDRF) for additional recommendations and support. For additional information on screening and monitoring, refer to the guidance from the Barbara Davis Center for Diabetes.8

CGM=continuous glucose monitoring; DKA=diabetic ketoacidosis; HbA1c=hemoglobin A1c; JDRF=Juvenile Diabetes Research Foundation; LAAD=longitudinal access and adjudication data; OGTT=oral glucose tolerance test; RBG=random blood glucose; SMBG=self-monitoring blood glucose; T1D=type 1 diabetes; T2D=type 2 diabetes.

Important Safety Information Anchor

IMPORTANT SAFETY INFORMATION

WARNING: Viral Reactivation

  • Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia.
  • Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD.

WARNINGS AND PRECAUTIONS

Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV have been reported with TZIELD. During and within 2 months of TZIELD treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV-associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk. The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia. Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., PCR testing). TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. During treatment with TZIELD, regularly monitor lymphocyte counts and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion.  If viral reactivation is suspected, discontinue TZIELD and obtain viral load (e.g., PCR) promptly. If viral reactivation is confirmed, permanently discontinue TZIELD.

Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. CRS manifestations in TZIELD-treated patients included fever, nausea (with or without vomiting), fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.

Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.

Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Obtain a CBC prior to starting TZIELD and monitor white blood cell counts during TZIELD treatment. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), permanently discontinue TZIELD.

Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.

Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.

  • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.
  • Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.

ADVERSE REACTIONS

Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm. To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy. Report pregnancies to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi
  • Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Please see full Prescribing Information, including Boxed WARNING and patient selection criteria. 

INDICATION

TZIELD (teplizumab-mzwv) is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 1 year of age and older with Stage 2 T1D.

REFERENCES

  1. American Diabetes Association Professional Practice Committee for Diabetes. Standards of care in diabetes—2026. Diabetes Care. 2026;49(suppl 1):S1-S371.
  2. Phillip M, Achenbach P, Addala A, et al. Consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes. Diabetes Care. 2024;47(8):1276-1298.
  3. Wenzlau JM, Juhl K, Yu L, et al. The cation efflux transporter ZnT8 (Slc30A8) is a major autoantigen in human type 1 diabetes. Proc Natl Acad Sci USA. 2007;104(43):17040-17045.
  4. Winkler C, Schober E, Ziegler AG, et al. Markedly reduced rate of diabetic ketoacidosis at onset of type 1 diabetes in relatives screened for islet autoantibodies. Pediatr Diabetes. 2012;13(4):308-313.
  5. Holt RIG, DeVries JH, Hess-Fischl A, et al. The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2021;64(12):2609-2652.
  6. TZIELD Prescribing Information. Provention Bio, Inc.
  7. Data on File. Sanofi.
  8. Simmons KMW, Frohnert BI, O’Donnell HK, et al. Historical insights and current perspectives on the diagnosis and management of presymptomatic type 1 diabetes. Diabetes Technol Ther. 2023;25(11):790-799.

© 2026 Sanofi. All rights reserved. MAT-US-2503243-v3.0-04/2026

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

WARNING: Viral Reactivation

  • Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia.
  • Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD.

WARNINGS AND PRECAUTIONS

Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV have been reported with TZIELD. During and within 2 months of TZIELD treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV-associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk. The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia. Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., PCR testing). TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. During treatment with TZIELD, regularly monitor lymphocyte counts and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion.  If viral reactivation is suspected, discontinue TZIELD and obtain viral load (e.g., PCR) promptly. If viral reactivation is confirmed, permanently discontinue TZIELD.

Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. CRS manifestations in TZIELD-treated patients included fever, nausea (with or without vomiting), fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.

Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.

Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Obtain a CBC prior to starting TZIELD and monitor white blood cell counts during TZIELD treatment. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), permanently discontinue TZIELD.

Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.

Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.

  • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.
  • Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.

ADVERSE REACTIONS

Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm. To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy. Report pregnancies to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi
  • Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Please see full Prescribing Information, including Boxed WARNING and patient selection criteria. 

INDICATION

TZIELD (teplizumab-mzwv) is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 1 year of age and older with Stage 2 T1D.