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.
Trace T1D
familial risk
Identify ≥2 pancreatic islet autoantibodies
Monitor for dysglycemia
Educate patients and families
Determining when and which methods of screening are appropriate is up to the healthcare provider.
TRACE
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.
Up to 15x greater risk of developing T1D2
IDENTIFY
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
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.
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
MONITOR
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
Frequency1
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
Educate patients and families
Educate patients and families on what’s next1:
Expand the care team by referring patients to professionals who can support mental health and other needs.
Advise patients and caregivers to be vigilant for symptoms of hyperglycemia and diabetic ketoacidosis (DKA).
Discuss the potential benefits and risks of pharmacological intervention if eligible.
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.
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.
