How to screen

The American Diabetes Association (ADA) recommends testing for 4 autoantibodies (AAbs)¹

The ADA recommends screening for¹:

Glutamic acid decarboxylase 65 AAb (GADA)
Insulinoma-associated antigen 2 AAb (IA-2A)
Insulin AAb (IAA)
Zinc transporter-8 AAb (ZnT8A)

When tested together, these 4 have been found to have a 98% autoimmunity detection rate at disease onset.²

A group of friends siting around a table together and having coffee

Patients who test positive for 2 or more AAbs from the list above should receive additional testing to confirm diagnosis and stage of autoimmune T1D.³

Barbara Davis Center Recommendations

Positive test results

To confirm the patient's diagnosis and create a follow-up plan, consider following the next steps.
If a patient’s initial screening test is positive for T1D-associated AAbs:

Negative test results⁴

To improve sensitivity of T1D detection and confirm a negative screening test, consider following the next steps.

If a patient's initial screening test is negative for T1D-associated AAbs:

The above mentioned recommendations from BDC propose an approach to screening for T1D and monitoring those at risk. Currently, there is no widely adopted protocol for screening and monitoring. The appropriate approach for your practice and your patients may vary.

Screening for AAbs is informative at any age; the optimal time to start screening is in the second year of a child’s life.⁴

Please note that TZIELD is indicated for eligible patients 8 years of age and older.

Your guide to identifying at-risk patients

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.

BDC=Barbara Davis Center; CGM=continuous glucose monitoring; HbA1c=hemoglobin A1c; OGTT=oral glucose tolerance test.

References: 1. American Diabetes Association Professional Practice Committee. Diagnosis and classification of diabetes: standards of care in diabetes—2024. Diabetes Care. 2024;47(Suppl 1): S20—S42. 2. 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. 3. Scheiner G, Weiner S, Kruger D, Pettus J. Screening for type 1 diabetes: Role of the diabetes care and education specialist. ADCES Pract. 2022;10(5):20-25. 4. 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. 5. American Diabetes Association. Blood glucose & A1C diagnosis. Accessed January 18, 2024. https://diabetes.org/about-diabetes/diagnosis 6. Type 1 Diabetes TrialNet. Protocol TN-10. Version June 2014. Accessed May 5, 2023. https://cdn.clinicaltrials.gov/large-docs/61/NCT01030861/Prot_000.pdf