Skip to Main Content

Proactive screening & monitoring

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

A young girl holding the handlebars on her bicycle and smiling
A young girl holding the handlebars on her bicycle and smiling

The ADA recommends proactively screening at-risk patients for the following 4 islet AAbs1,2*

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

*Islet cell AAb (ICA) is also available for testing.3

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.4

What screening 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%5

A checklist and a writing utensil
~40% of adults

over the age of 30 with T1D are initially
diagnosed with T2D2,6

Two arrows crossing over each other and going in the same direction

Identifying TZIELD-eligible patients in presymptomatic Stage 21

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 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 longitudinal access and adjudication data 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 patients3,8

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 random BG, plus SMBG at home.

§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.

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

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

§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.

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 random BG, plus SMBG at home

§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.

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 random BG, plus SMBG at home.

§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.

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

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

§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.

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 random BG, plus SMBG at home

§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.

Pediatric Patients3,5

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%.5

TZIELD is indicated for people 8 years of age and older in Stage 2 T1D.1

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

§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.

  • 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

TZIELD is indicated for people 8 years of age and older in Stage 2 T1D.1

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

§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.

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 in children by ~88%.5

TZIELD is indicated for people 8 years of age and older in Stage 2 T1D.1

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

§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.

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%.5

TZIELD is indicated for people 8 years of age and older in Stage 2 T1D.1

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

§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.

  • 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

TZIELD is indicated for people 8 years of age and older in Stage 2 T1D.1

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

§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.

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 in children by ~88%.5

TZIELD is indicated for people 8 years of age and older in Stage 2 T1D.1

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

§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.

Important Safety Information Anchor

INDICATION

TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. 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. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), 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 live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
    • 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.

ADVERSE REACTIONS

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm.
  • 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 patient selection criteria, and Medication Guide. View Important Safety Information page.

REFERENCES

  1. Scheiner G, Weiner S, Kruger DF, Pettus J. Screening for type 1 diabetes: Role of the diabetes care and education specialist. ADCES Pract. 2022;10(5):20-25.
  2. American Diabetes Association Professional Practice Committee. Diagnosis and classification of diabetes: standards of care in diabetes—2025. Diabetes Care. 2025;(48)(Suppl 1):S27-S49.
  3. TZIELD Prescribing Information. Provention Bio, Inc; 2023.
  4. 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.
  5. 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 U S A. 2007;104(43):17040-17045.
  6. Data on file. IQVIA. Data as of April 2024.
  7. 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.
  8. American Diabetes Association. Blood glucose & A1C diagnosis. Accessed January 18, 2024. https://diabetes.org/about-diabetes/diagnosis
  9. Winkler C, Schober E, Ziegler A-G, 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.
More information
Need Help?

Call 1-844-778-2246 to speak with a TZIELD COMPASS representative

© 2026 Sanofi. All rights reserved. MAT-US-2503243-v2.0-10/2025

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. 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. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), 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 live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
    • 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.

ADVERSE REACTIONS

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm.
  • 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 patient selection criteria, and Medication Guide. View Important Safety Information page.