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LEARNING OBJECTIVES

After completing Module 6, the learner should be able to:

   1. Explain why communication regarding screening results should acknowledge uncertainty of unconfirmed results.
   2. Name key elements of results communication.
   3. Name mechanisms to communicate regarding risk of developing Stage 3 (symptomatic) T1D in the electronic health     
       records (EHR).

Results Notification

06 |

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Islet Autoantibody Screening Results are Negative 

All 4 islet autoantibodies should be included in testing: GADA, IA-2A, IAA and ZnT8A. In a person with negative autoantibody results and in whom all 4 autoantibodies were not included, the screening should be repeated to test for all 4 autoantibodies utilizing a highly specific method.

        If a patient’s autoantibody results are negative for all four islet autoantibodies, they are at a lower risk for developing symptomatic Stage 3 T1D. Repeat screening is recommended for the following individuals at specific intervals below:​

        1.  Repeat testing should take place every 1 to 3 years, if there is a personal or family history of an     

             autoimmune disease (e.g. celiac disease, Hashimoto's thyroiditis, Graves' disease, lupus, etc.).

        2.  Rescreening should take place in those under age 15. Recommended intervals are: 1-3 yrs.,
             4-6yrs., and 9-11yrs.

        3.  Immediate autoantibody testing, measurement of a fasting or random glucose and A1c % should
             be performed in a person who reports symptoms of type 1 diabetes.

​

Islet Autoantibody Screening Results are Positive

  • An additional serum sample should be collected to confirm positive autoantibody results.

  • The confirmatory visit should be immediate in those with high risk of progression to Stage 3 T1D.

  • The timing of the confirmatory visit for those at lower risk for progression to symptomatic Stage 3 T1D can take place within several weeks. (see Module 5).

​

Caution should be exercised when giving advice regarding risk of progression to Stage 3 T1D delivered to persons/individuals/families in advance of autoantibody confirmation. 

 

The rationale for cautious delivery of progression risk is:

  • Risk estimates were derived from prospective studies based upon confirmed islet autoantibody positivity using highly specific and sensitive tests.

  • Prospective clinical trial participants underwent serial testing in childhood to identify prompt autoantibody seroconversion, typically within months of the initial event.

  • General population individuals screened may have developed single or multiple autoantibodies years before testing.

 

Consequently: ​

  • Language used for risk communications should also acknowledge uncertainty in advance of confirmatory testing.

    • Example: “If confirmed, these results mean that the risk for developing clinical type 1 diabetes mellitus may be increased. It does NOT mean you (or our child) will definitely get diabetes.”

  • ​Individuals/families must be informed of the need for confirmatory testing to estimate risk of progression.

  • Screening results communication should include information regarding symptoms of diabetes (e.g. polyuria, polydipsia, weight loss, fatigue, etc.) and instructions on what to do if symptoms are present.

Module Authors: Rachel Karban, Patricia Gesualdo, Kimberly Bautista

Communicating with individuals/families regarding islet autoantibody 
positivity and confirmatory results

 

RETURN OF RESULTS

Two approaches to including islet autoantibody results in the medical record:

  1. ​Islet autoantibody tests ordered through standard lab orders (a clinical protocol):
    Results should be sent to the ordering provider by the commercial or CAP/CLIA certified lab such as LabCorp or Quest with a direct lab-to-clinic interface.

  2. Testing is completed through a research study:
    Positive results will be communicated to the     individual/parents by a research coordinator followed by written results. The results can be shared through HIPAA-compliant data transfers with informed consent in place.

​

CONTENT OF RESULTS COMMUNICATION

All communication of CONFIRMATION results should include:

  1. Islet autoantibody positivity/negativity with Ab levels and cutoff values.

  2. Interpretation of autoantibody results should include an estimation of risk based upon the number of autoantibodies, symptoms and/or glycemia.

    • ​For example: An individual with 2 autoantibodies and dysglycemia will have a 75% risk of developing symptomatic Stage 3 T1D in 5 years.

    • Use of infographics or a comparison to the risk in the general population can be useful to help patients/families understand risk.

  3. Describe methods of monitoring glucose (CGM, A1C, blood glucose measures) and plan for follow-up.

  4. Emphasize the importance of monitoring and follow-up.

  5. Reinforce the signs and symptoms of type 1 diabetes (polyuria, polydipsia, weight loss, fatigue, etc.) and need to inform a healthcare professional immediately.

  6. Reassurance that the clinical team will support the person/family and teach them what they need to know.

​

The primary goal of communicating autoantibody results is to engage the individual/persons/family
in the importance of monitoring. The risk of developing symptomatic Stage 3 T1D will increase if the individual/person develops additional antibodies with positivity and/or signs of dysglycemia.(1) Early diagnosis of symptomatic Stage 3 T1D is essential for interventions, better treatment outcomes, and preventing diabetic ketoacidosis (DKA) at diagnosis. Please refer to Module 8: Monitoring for further details.

Risk Estimation for Families Based on Islet Autoantibody Results

 

Single Islet Autoantibody Status: Suggests only one autoantibody has been detected.

  • Implies a low risk of developing symptomatic Stage 3 type 1 diabetes. 

  • Rescreening is recommended annually.

​

Single High-Affinity Islet Autoantibody Status: Suggests one autoantibody is positive and has been confirmed using a highly-specific autoantibody assay method (e.g. radio binding assay, and confirmed by ECL [electrochemiluminescence], currently only available in a research laboratory, see Module 4 (2)). 

  • The risk of developing symptomatic Stage 3 T1D in these circumstances is 30% over the next 5 years and 50% over the next 10 years. 

  • Rescreening is recommended every 6 months.

​

Multiple Islet Autoantibody Status: Suggest two or more autoantibodies are positive and at least two have been confirmed by repeat testing.

  • Multiple autoantibody positivity with confirmation suggests a 50% risk of developing symptomatic Stage 3 T1D in 5 years and 70% risk in 10 years with a lifetime risk approaching 100%.(3)  

  • Rescreening in the research setting is recommended every 3-6 months. If in a clinical setting, there is currently no recommendation to retest autoantibodies once a patient is multiple autoantibody positive (please refer to the monitoring guidelines in Module 8).

​

Electronic Health Records (EHR) Methods for Staging & Monitoring Early T1D

Evaluation and management of individuals with early-stage (presymptomatic) type 1 diabetes can prevent DKA while progressing to Stage 3 T1D. Electronic medical records can be utilized to identify an at-risk type 1 diabetes population.

 

Problem List Entries for Type 1 Diabetes: The problem list is standard in most medical records systems and is used to track active clinical issues, to alert health care teams to factors/conditions that may impact current care, and to guide clinical decision making. Problem lists are mapped to ICD-10 diagnosis codes; however, the ICD-10 tabular does not currently include codes specific to early-stage (presymptomatic)
T1D (these will be implemented in October 2024). ICD-10 codes for elevated antibody titer (R76.0) or
pre-diabetes (R73.03) for Stage 1 and Stage 2 T1D can be utilized in the meantime.

​

Starting October 2024, the following ICD-10 codes may be used:

                     E10.A0 – Type 1 diabetes mellitus, presymptomatic, unspecified
                     E10.A1 – Type 1 diabetes mellitus, presymptomatic, Stage 1
                     E10.A2 – Type 1 diabetes mellitus, presymptomatic, Stage 2
 

Example:  In our institution we developed customized problem list entries to identify at-risk presymptomatic T1D patients. As our problem list entries are mapped to R73.03 for both Stage 1 and Stage 2 T1D, they are required to include the term “prediabetes” and appear as shown in Figure 1.

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FIGURE 1

Alerts: Best practice advisories (BPAs), clinical alerts, or FYI alerts can be built into an organization’s EHR system. These strategies differ in how they appear to the clinician, whether they require action, and in which contexts they are seen. All can alert the clinician to important information that may impact current evaluation and decision making. They can suggest evaluation or whom to contact for consultation. BPAs can also be linked to order sets, such as A1c, random glucose or urinalysis for glucose and ketones. (Figure 2)

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FIGURE 2

Anchor 1
REFERENCES

1.  Simmons K, Frohnert B, O’Donnell H, et al. Historical Insights and Current Perspectives on the Diagnosis and Management of Pre-Symptomatic Type 1     

     Diabetes. Diabetes Technol Ther. 2023 Nov;25(11):790-799.

2.  Jia X, Gu Y, High H, Yu L. Islet autoantibodies in disease prediction and pathogenesis. Diabetol Int 2019;11(1):6–10.

3.  Insel RA, Dunne JL, Atkinson MA, et al. Staging Presymptomatic Type 1 Diabetes: A Scientific Statement of JDRF, the Endocrine Society, and the American
     Diabetes Association. Diabetes Care 2015;38(10):1964–74.

This program was developed independently
by the Barbara Davis Center for Diabetes and supported in part by a grant from Sanofi US.

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Questions@STOPT1Dprogram.org

Call: 303-724-STOP

Version 2.0_6.2024

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