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T1D Information for PROVIDERS

 WHY screen  my patients for pre-symptomatic T1D?

 HOW do I screen  my patients for pre-symptomatic T1D?

 WHAT are the stages  of Type 1 Diabetes?

Result: Screened  POSITIVE  

Result: Screened  NEGATIVE  

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 WHY screen  my patients for pre-symptomatic T1D?

In type 1 diabetes (T1D), the immune system destroys cells in the pancreas that make insulin. Insulin helps us use the energy from foods we eat. A person living with T1D needs lifelong daily insulin injections to stay healthy. Screening for T1D — with a simple blood test for T1D associated antibodies (islet autoantibodies) — can identify individuals who are at high risk of developing T1D and can prevent children from getting very sick.

 

1. National and international consensus guidelines recognize T1D before symptoms develop. 

In 2015, the American Diabetes Association, JDRF, and Endocrine Society released T1D STAGING GUIDELINES based on islet autoantibody status and glycemic status in an effort to identify pre-symptomatic disease. The presence of multiple islet autoantibodies is associated with a 44% 5-year risk and a 70% 10-year risk of clinical T1D. Without an effective intervention, the presence of multiple islet autoantibodies is considered a ‘point of no return’ as there is a lifetime risk of T1D development approaching 100%. Early detection allows prevention of diabetic ketoacidosis (DKA) at diabetes onset and provides patients and their families with opportunities to participate in interventions and clinical trials that may delay or prevent disease.

 

The 3 Stages are as follows (click to enlarge):

2. Most children with T1D (90%)  DO NOT have a family member with T1D.

Although children who have a family member with T1D have a 15-20x increased risk of developing T1D, the large majority of children diagnosed with T1D (90%) do not have a family history of T1D. Because the clinical symptoms of T1D overlap with common pediatric illnesses, T1D is often unrecognized in families who are not familiar with T1D signs and symptoms.

3. Screening for T1D and monitoring patients who screen positive over time can prevent diabetic ketoacidosis (DKA) and may improve long term glycemic control.

The rate of diabetic ketoacidosis (DKA) at the time of T1D onset is increasing over time throughout the U.S. Although rates vary across the United States, in Colorado 58% of children diagnosed with T1D present in DKA. DKA is life threatening and associated with complications such as cerebral edema, memory and cognitive defects and worsened long-term glycemic control, thereby increasing the risk for vascular complications. An estimated 120 children in the U.S. die every year as the result of a delayed diagnosis of T1D. Children detected by screening for T1D associated antibodies rarely progress to DKA. Prior studies at the Barbara Davis Center, including the TEDDY and DAISY studies have shown that 90% of children who know they have the T1D associated antibodies and are connected with a healthcare team for routine metabolic monitoring avoid DKA at onset of diabetes. 

4. T1D Prevention trials may be available if your patient screens positive. 

5. Therapies approved for early T1D treatment

On November 17, 2022, the FDA approved TZIELD (teplizumab). TZIELD is the first FDA-approved treatment for early diabetes and has the potential to delay the onset of clinical type 1 diabetes (T1D). It is approved for adults and pediatric patients aged 8 years and older with Stage 2 T1D. Stage 2 T1D is when a person has 2 or more T1D-associated autoantibodies (GAD, IAA, IA-2, ICA512, and/or ZnT8A) and dysglycemia. Dysglycemia in stage 2 T1D is defined by the American Diabetes Association as a fasting blood glucose of 100-125 mg/dl, a 2-hour glucose during an oral glucose tolerance test of 140-199 mg/dl or an HbA1c between 5.7-6.4%. 

Research done in TrialNet showed that people who received TZIELD had an average of 2 more years before the onset of clinical T1D (Stage 3 T1D) compared to those who did not receive TZIELD. Additionally, more people who were given TZIELD had not been diagnosed with Stage 3 T1D by the end of the study compared with people who did not receive TZIELD. TZIELD is given as an intravenous (IV) infusion once a day, every day, for 14 days. TZIELD is an anti-CD3 monoclonal antibody that may work by changing the phenotype of activated T-cells. Evaluation for Tzield treatment can take place at the Barbara Davis Center Early T1D Clinic in Aurora, CO, or in several other locations throughout the United States that may be closer to you.

WHY screen
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 HOW do I screen  my patients for pre-symptomatic T1D?

There is only one set of markers in the blood — islet autoantibodies: GADA, IA-2A, insulin antibody, ZnT8A, ICA — that are associated with the development of type 1 diabetes (T1D). Clinical, consumer and research labs measure T1D associated antibodies (and/or celiac antibodies), and there are several screening programs available in the United States.


To determine the best way to screen your patient for T1D risk, please email us at Questions@AsktheExperts.org or call 303-724-1212. We will guide you through choosing the screening lab or program listed below that is the best fit for your patient. Or if your patient has already been screened and you would like help determining the next steps, please email or call, and a member of ASK the Experts will reach out to you.

VIEW / DOWNLOAD (PDF) Chart of U.S.-based Screening Programs/Laboratories

HOW do I screen

 WHAT are the stages  of Type 1 Diabetes?

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  2h-PG = 2-hour plasma glucose  /  FPG = fasting plasma glucose  /  RPG = random plasma glucose

ADA Standards of Medical Care in Diabetes: In absence of unequivocal hyperglycemia,
  diagnosis requires 2 abnormal test results from same or separate samples

** TZIELD Treatment: Potential eligible patients are those who are 8 years or older with stage 2 T1D

Stages of T1D

Result: Screened  POSITIVE  

Upon receiving a positive screening for your patient, please check a blood glucose level and a hemoglobin A1c to determine glycemic status and rule out a diagnosis of diabetes.

 

A positive screening test NEEDS TO BE CONFIRMED by measuring all four T1D-associated antibodies (GAD-65 antibody, IA-2 antibody, insulin antibody, ZnT8 antibody). These antibodies should be measured from serum in a CLIA-approved reference laboratory. Ideally, the lab should be an active participant in the Islet Autoantibody Standardization program.

 

If you need help determining how or where to order a confirmation blood test for type 1 diabetes associated antibodies, please provide your name, phone number and email address below.

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If your patient screened POSITIVE, and confirmed POSITIVE,
your patient should be monitored for progression to type 1 diabetes.

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Please provide your name, phone number and email address — and an Ask the Experts team member will contact you to help determine the best way to care for your patient and provide helpful resources.

 

We aspire to build a network of “Local Experts”. If you want to partner with ASK the Experts so that we can refer patients with early T1D in your area to you for education and metabolic monitoring, please check the box below.

Screened POSITIVE

Result: Screened  NEGATIVE  

A negative antibody result does not mean that a person will never develop type 1 diabetes. The autoimmune process of type 1 diabetes can occur at anytime during a person's life. Annual re-screening is recommended or sooner if the person develops type 1 diabetes symptoms.

  • PERSONAL HISTORY
    of autoimmunity;
                and/or
     

  • FAMILY HISTORY of autoimmune disease

CONSIDER REPEAT SCREENING
ANNUALLY

  • Repeat at ANY age if symptoms of type 1 diabetes appear (also check glucose level and HbA1c)

  • NO PERSONAL HISTORY 
    of autoimmunity;

                  and

  • NO FAMILY HISTORY
    of autoimmune disease

For AGE <15yrs:
 

  • Repeat at ANY age if symptoms of type 1 diabetes appear (also check glucose level and HbA1c)

Screened NEGATIVE
Provider FORM

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