Type 1 Diabetes Early Detection
Screening for early-stage autoimmune T1D
The T1D Screening assay is an autoantibody test designed to help clinicians identify individuals at risk of or in the early stages of Type 1 Diabetes (T1D).
The T1D Screening assay offers:
- Comprehensive autoantibody testing: Covers key markers such as GAD, IA-2, ZnT8, and IAA to assess the presence of autoimmunity associated with T1D3.
- First-time testing: Available for individuals being screened for T1D autoantibodies for the first time.
- Confirmatory Testing: To validate previous positive results.
- Repeat testing: For individuals who have had a single positive or negative result in the past, ensuring continued monitoring for the development of additional autoantibodies.
Resources
About autoimmune type 1 diabetes (T1D)
Autoimmune T1D is an condition characterized by the immune system's progressive destruction of insulin-producing beta cells in the pancreas, resulting in lifelong exogenous insulin-dependance.4,5
Autoantibodies associated with the development of T1D include.3
- Insulin autoantibody (IAA)
- GAD autoantibody (GADA)
- Insulinoma antigen-2 autoantibody (IA-2A)
- Zinc transporter type 8 autoantibody (ZnT8A)
Detection of one or more of these autoantibodies prior to the clinical diagnosis of T1D can indicate an increased risk of the development of T1D, as well as early stages of the disease.3
Early-stage autoimmune T1D
Autoimmune T1D begins months or years before the onset of symptoms and hyperglycemia, and is classified by three distinct stages. Stage 1 and Stage 2 represent early-stage presymptomatic autoimmune T1D. In these stages, individuals have two or more autoimmune T1D-associated islet autoantibodies. In stage 1, glucose levels are within normal range, however, individuals in stage 2 experience dysglycemia. Stage 3 is when symptoms appear, hyperglycemia is observed and a clinical diagnosis typically takes place. 1
Who should be screened for early-stage T1D?
Screening for early-stage autoimmune T1D should be considered for high-risk individuals who include:
- First and second-degree relatives of someone with T1D, meaning individuals who have a parent, sibling, child, grandparent, cousin, aunt or uncle with autoimmune T1D.1,2
- Individuals diagnosed with autoimmune disorders, particularly celiac disease and thyroid disease.
- Patients with pre-diabetes who may have been misdiagnosed, particularly those without overweight or obesity.
The benefits and downsides of early-detection
Early screening can identify individuals at risk before severe symptoms appear, allowing for earlier planning and monitoring. This proactive approach may help prevent critical illness and manage the condition more effectively from the outset.11 It also reduces the trauma of an acute diagnosis for patients and families.14 T1D frequently presents with preventable life-threatening complications, such as diabetic ketoacidosis (DKA), which can lead to hospitalization, severe psychological impact, serious health consequences and may lead to poorer cognitive development, especially when it occurs in childhood.14 Early detection can reduce the rate of DKA from approximately 50% among patients who don’t undergo screening to less than 5% in screened populations.15
This is particularly important given that DKA at the onset of T1D is associated with increased mortality risk, longer hospitalizations, higher insulin requirements, shorter remission period, and worse glycemic control over time.14
Early diagnosis of T1D positively affects longevity and decreases morbidity, all while having a significant positive impact on the quality of life and mental health of patients and their families.
Some individuals and families may experience anxiety when considering screening and waiting or receiving results. This can be mitigated with education and counselling. Studies has shown that anxiety levels decrease with time, and are lower than anxiety experienced at a sudden T1D diagnosis.
This test is designed to
- Enhance early detection of T1D risk and early stages of the disease, enabling proactive monitoring and management.
- Facilitate clinician decision-making through detailed and accurate testing reports.
Through screening for autoantibodies, it is possible to detect T1D months or even years before the first symptoms appear. Islet autoantibody screening can be performed using a small sample of capillary or venous blood.
Acceptable sample types
- Dried Blood Spot (DBS): The DBS method collects blood samples obtained from finger or heel puncturing on a matrix paper, which is subsequently dried.
The DBS sample collection can take place at the point of care, by a physician, nurse, NP or pharmacist (in some provinces).
Alternatively, the DBS sample can be collected in a lab patient service centre. A mobile phlebotomy option is also available and is reserved for individuals who live >50 km from the ordering practitioner, or for individuals with mobility/accessibility challenges. - Venous blood sample (VBS): The VBS draws venous blood through venipuncture. The VBS sample collection can take place at the point of care, by a physician, nurse, NP or pharmacist (in some provinces). Alternatively, the VBS sample can be drawn in a lab patient service centre.
Note that while this is an acceptable sample type, kits for testing are not currently available.
References
- Insel RA, 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.
- Besser REJ, et al. ISPAD Clinical Practice Consensus Guidelines 2022: Stages of type 1 diabetes in children and adolescents. Pediatr Diabetes 2022;23(8):1175–87.
- Kawasaki E. Anti-Islet Autoantibodies in Type 1 Diabetes. Int J Mol Sci 2023;24(12):10012.
- Punthakee Z, et al. Definition, Classification and Diagnosis of Diabetes, Prediabetes and Metabolic Syndrome. Can J Diabetes 2018:42(Suppl 1):S10–S15. doi: 10.1016/j.jcjd.2017.10.003.
- Karges B, et al. A comparison of familial and sporadic type 1 diabetes among young patients. Diabetes Care 2021;44(5):1116–24.
- TrialNet. Stages of Type 1 Diabetes. Available at: https://www.trialnet.org/events-news/blog/type-1-diabetes-staging-classification-opens-door-intervention. Accessed July 23, 2024.
- Sims EK, et al. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes 2022;71:610–23.
- JDRF. June 2024 newsletter.
- Ekoe J-M, et al. Screening for Diabetes in Adults. Can J Diabetes 2018;42:S16–9.
- TrialNet. TrialNet Recommendations for Clinicians. Available at: https://www.trialnet.org/healthcare-providers. Accessed July 12, 2024. Kawasaki E. Anti-Islet Autoantibodies in Type 1 Diabetes. Int J Mol Sci 2023;24(12):10012.
- TrialNet. Pathway to Prevention. Available at: https://www.trialnet.org/our-research/risk-screening. Accessed July 12, 2024.
- JDRF. CanScreen T1D: Screening Research Consortium in Canada Announced. Available at: https://jdrf.ca/canscreent1d-screening-research-consortium-in-canada-announced/. Accessed July 12, 2024.
- Besser REJ, et al. ISPAD clinical practice consensus guidelines 2022: Stages of type 1 diabetes in children and adolescents. Pediatr Diabetes 2022;23(8):1175–87.
- Simmons KM, Sims EK. Screening and prevention of type 1 diabetes: Where are we? J Clin Endocrinol Metab. 2023;108:3067-3079.
- Alonso GT, Coakley A, Pyle L, Manseau K, Thomas S, Rewers A. Diabetic ketoacidosis at diagnosis of type 1 diabetes in Colorado children, 2010–2017. Diabetes Care. 2020;43:117-121.
How to order
Step 1
Test selection and place order
Step 2
Specimen collection and Shipment
Step 3
Sample shipment
How to order
Test selection and place order
Select the correct test for your patient, and fill out the appropriate test requisition form.
- Please make sure that all sections are completed and that the patient has signed the informed consent form.
Specimen collection and Shipment
Collection by the health care provider
Obtain a sample for testing from the patient using one of the provided Revvity Omics test packs. If you do not have a kit available in your office, please contact us here and we can have one sent out to your office.
- Ensure that the patient sample is labeled with the patient’s name and date of birth.
- Please note that all biochemical assays require a Dried Blood Spot (DBS) sample. Step-by-step instructions for collecting a DBS sample can be found here.
- Samples may be submitted without a collection kit by following the guidelines for specimen requirements and completing the requisition form.
Package the patient sample, informed consent form, and test requisition form back into the test kit, and utilize the included pre-paid shipping label to return the kit to Revvity Omics for processing.
- As a patient’s clinical presentation is an essential part of fully interpreting genetic test results, we ask that you kindly include any applicable medical records or clinical notes with the sample at the time of test submission.
- Coordinate collection with Revvity Omics.
Send a sample
Package the patient sample, informed consent form, and test requisition form back into the test kit, and utilize the included pre-paid shipping label to return the kit to Revvity Omics for processing.
This testing service has not been cleared or approved by the U.S. Food and Drug Administration. Testing services may not be licensed in accordance with the laws in all countries. The availability of specific test offerings is dependent upon laboratory location. The content on this page is provided for informational purposes only, not as medical advice. It is not intended to substitute the consultation, diagnosis, and/or treatment provided by a qualified licensed physician or other medical professionals