Now is the T.I.M.E. to screen for T1D

Screening and staging individuals at increased risk may create opportunities to manage type 1 diabetes (T1D) before the onset of Stage 3 T1D.1

Use T.I.M.E. to your advantage

Four steps to help you identify patients that may benefit from disease management before onset of Stage 3 T1D.

Analog clock icon with a "T" in the center for "Trace"

Trace T1D
familial risk

Analog clock icon with an "I" in the center for "Identify"

Identify ≥2 pancreatic islet autoantibodies

Analog clock icon with an "M" in the center for "Monitor"

Monitor for dysglycemia

Analog clock icon with an "E" in the center for "Educate"

Educate patients and families

Determining when and which methods of screening are appropriate is up to the healthcare provider.



Trace familial risk

Talk to first-degree relatives about screening1

Your patients’ first-degree relatives—parents, siblings, children—should
understand the importance of screening for type 1 diabetes (T1D).

Discuss the importance of familial screening with your patients.

These first-degree relatives have a higher risk of T1D than the general population.

Warning icon

Up to 15x greater risk of developing T1D2



Identify ≥2 pancreatic islet autoantibodies

Screen for pancreatic islet autoantibodies (AAbs)2

AAbs are a defining characteristic and reliable indicator of T1D at any stage of the disease.

Identifying ≥2 positive AAbs from the following list confirms a diagnosis of T1D:

  • Glutamic acid decarboxylase 65 autoantibody (GADA)
  • Insulinoma-associated antigen 2 autoantibody (IA-2A)
  • Insulin autoantibody (IAA)
  • Islet cell autoantibody (ICA)
  • Zinc transporter-8 autoantibody (ZnT8A)

Autoantibody screening options

Table lists autoantibody (AAb) screening options available through commercial labs, TrialNet, ASK, and online ordering.


This may not be an exhaustive list of available screening options. The appropriateness of any AAb screening test and validity of the test results are up to the requesting physician to determine.

It is recommended to screen for the entire panel of AAbs to ensure that individuals with T1D are able to be diagnosed properly.

Commercial lab order codes*

These commercial labs offer screening tests and panels that cover all 5 pancreatic islet autoantibodies.

Test/panel names and order codes

GAD65, IA-2, and Insulin Autoantibody


Zinc Transporter 8 (ZnT8) Antibody


Islet Cell Antibody Screen with Reflex to Titer


Test/panel names and order codes

Diabetes Autoimmune Profile


Antipancreatic Islet Cells


This is a list of type 1 diabetes codes available as of April 4, 2023; appropriate codes can vary by patient, setting of care, and payer. Correct coding is the responsibility of provider submitting the claim for the item of service.

*Provention Bio, Inc. does not make any representation or guarantees concerning reimbursement or coverage for any service or item.

Potential considerations following results1

If ≤1 autoantibody was detected, additional screening may be needed for high-risk patients

If ≥2 autoantibodies are detected:

  • Explain the significance of the results to your patient and their family
  • Gain commitment of periodic follow-up glycemic testing
Doctor/patient consultation icon


Monitor for dysglycemia

Follow-up and monitor for dysglycemia

Dysglycemia is defined as a recurring fluctuation of glucose levels (outside of normal range).11

Signs of dysglycemia include11,12:

  • Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)
  • Fasting Plasma Glucose (FPG) 100-125 mg/dL
  • 2-H Plasma Glucose (2-H PG) 140-199 mg/dL during OGTT
  • 30-/60-/90-minute PG ≥200 mg/dL during OGTT
  • A1c 5.7-6.4% or ≥10% increase in consecutive A1c levels


There are currently no uniform guidelines for monitoring individuals in early-stage T1D.

  • In office: standard monitoring includes a 2-hour OGTT and an A1c test every 6 months
  • At home: Fasting and 1- or 2-hour postprandial glucose levels with finger-stick glucose monitoring or use of continuous glucose monitoring (CGM). At-home monitoring is not diagnostic

In patients with ≥2 AAbs, dysglycemia without overt hyperglycemia* indicates Stage 2 T1D.1

*Overt hyperglycemia means a clear clinical diagnosis could be made (ie, patient in a hyperglycemic crisis or with classic symptoms of hyperglycemia; PG of ≥200 mg/dL) or 2 abnormal screening test results, either from the same sample or in 2 separate test samples.11



Educate patients and families

Educate patients and families on what’s next1:

Expand patient care team icon

Expand the care team by referring patients to professionals who can support mental health and other needs.

Diabetic Ketoacidosis low insulin icon

Advise patients and caregivers to be vigilant for symptoms of hyperglycemia and diabetic ketoacidosis (DKA).

Medicine conversation icon

Discuss the potential benefits and risks of pharmacological intervention if eligible.

Start your appropriate patients today!



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.



  • 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.
1. Scheiner G, Weiner S, Kruger DF, Pettus J. Screening for type 1 diabetes: role of the diabetes care and education specialist. ADCES Pract. 2022:20-25.2. Couper JJ, Haller MJ, Greenbaum CJ, et al. ISPAD Clinical Practice Consensus Guidelines 2018: stages of type 1 diabetes in children and adolescents. Pediatr Diabetes. 2018;19(suppl 27):20-27.3. Data on file. Provention Bio, Inc.4. ASK. Screening locations. Accessed March 31, 2023. ASK. ASK study screening form. Accessed March 31, 2023. McQueen RB, Rasmussen CG, Waugh K, et al. Cost and cost-effectiveness of large-scale screening for type 1 diabetes in Colorado. Diabetes Care. 2020;43:1496-1503.7. Enable Biosciences. Choose a testing service. Accessed March 31, 2023. Enable Biosciences. The role of autoantibodies in type 1 diabetes. Published January 19, 2023. Accessed March 31, 2023. Quest Diagnostics. Test directory. Accessed March 31, 2023. Labcorp. Find a test. Accessed March 31, 2023. ElSayed NA, Aleppo G, Aroda VR, et al. Standards of care in diabetes—2023. Diabetes Care. 2023;46(suppl 1):S19-S40.12. Type 1 Diabetes TrialNet. Protocol TN-10. Version June 2014. Accessed May 5, 2023.