Upon completing this course, health care providers should be able to: 1. Understand the significance of early detection and intervention for T1D. 2. Be familiar with islet autoimmunity screening methods. 3. Explain the process of result confirmation. 4. Develop effective strategies for result notification, ensuring clarity and patient understanding. 5. Be familiar with monitoring protocols to track high-risk individuals with positive screening results. 6. Recognize the psychosocial impact of screening and monitoring on the patient and family. 7. Discuss the role of clinical trials and FDA-approved interventions in delaying onset of symptomatic T1D. 8. Collaborate with interdisciplinary teams to provide comprehensive care to individuals at high-risk of developing T1D. 9. Identify the key components of healthcare organizations required for effective pre-symptomatic diabetes screening and monitoring. 10. Describe screening strategies for relevant demographic groups.

CONTENT What is Type 1 Diabetes? • Understanding the natural history of type 1 diabetes – Autoimmunity – Pathogenesis of insulin loss – Pathogenesis of diabetic ketoacidosis (DKA) • Learn about three stages of type 1 diabetes • Identifying the silent phase of T1D through antibody testing • Type 1 vs Type 2 Diabetes ————— LEARNING OBJECTIVES After completing Module 1, the learner should be able to: Name factors which contribute to development of type 1 diabetes (T1D). Describe and differentiate the stages of T1D. Describe how lack of insulin leads to diabetic ketoacidosis (DKA). Compare and contrast type 1 and type 2 diabetes.

CONTENT Why Is Screening Important for Early Stage Type 1 Diabetes? Reducing the risk of diabetic ketoacidosis (DKA) can improve outcomes Anticipatory guidance and risk estimation Importance of screening in individuals with no family history Benefits of early diagnosis and long-term disease management Timing of islet autoantibody screening Availability of autoantibody screening ————— LEARNING OBJECTIVES After completing the Module 2, the learner should be able to: Estimate the effect of screening for islet autoantibodies and monitoring individuals at early-stage (presymptomatic) T1D on rate of diabetic ketoacidosis at diagnosis of Stage 3 (symptomatic) T1D. Describe groups of people who can benefit from screening for at early-stage (presymptomatic) T1D. Describe the three types of screening programs for islet autoantibodies in the US and give one example for each.

CONTENT High-risk populations What is known about the incidence and prevalence of islet autoantibodies in the US? Screening children for presymptomatic type 1 diabetes Screening general population adults for presymptomatic type 1 diabetes ————— LEARNING OBJECTIVES After completing Module 3, the learner should be able to: Describe patient historical elements that indicate higher risk for T1D. Estimate the percentage of general population children and adolescents are positive for one or more islet autoantibodies at some point during their lives. Describe the peak and distribution of the incidence of islet autoantibody seroconversion (1 or more confirmed islet autoantibodies) across the lifespan. Explain why differentiating T1D from T2D in newly-diagnosed diabetes is important.

CONTENT Testing for key islet antibodies: GADA, IAA, IA-2A, and ZnT8A Islet autoantibody assay methods: addressing variations in antibody testing Research, consumer and clinical screening options ————— LEARNING OBJECTIVES After completing Module 4, the learner should be able to: Name at least two methods of screening for islet autoantibodies as well as the advantages and limitations of each method. Describe at least two organizations or companies that offer islet autoantibody screening. Explain why positive screening results must always be followed by confirmation testing.

CONTENT Why confirmation is necessary Identifying higher-risk individuals for expedited follow-up Additional assessment at confirmation visit: – Performing HbA1c and blood glucose tests – Evaluating symptoms for confirmation Teaching patients home glucose testing ————— LEARNING OBJECTIVES After completing module 5, the learner should be to: Identify characteristics of individuals with a higher risk of progression to Stage 3 T1D. Indicate the criteria used for evaluating risk for progression. Understand the relationship between age of onset of islet autoimmunity and pace of disease progression. Explain the process of confirmation: timing, samples to collect and tests to conduct.

CONTENT Notifying Individuals About Screening Results When screening results are negative Notification regarding positive islet autoantibody (Ab+) screening results Explaining Single Antibody (SAB) vs. Multiple Antibody (MAB) results Comparing clinical screening vs. research results sharing methods Electronic Health Record (EHR) methods ————— LEARNING OBJECTIVES After completing Module 6, the learner should be able to: Explain why communication regarding screening results should acknowledge uncertainty of unconfirmed results. Name key elements of results communication. Name mechanisms to communicate regarding risk of developing Stage 3 (symptomatic) T1D in the electronic health records (EHR).

CONTENT Psychosocial Impact to Individual or Parent Learning About High Risk for T1D Cognitive: What do people understand about what we tell them? Is their risk perception accurate? Emotional: How do people feel when they learn they (or a loved one) are at risk for type 1 diabetes? Behavioral: What do people do when they learn about T1D risk for themselves or their child? Needle anxiety Engagement, coping and barriers to follow-up Resources ————— LEARNING OBJECTIVES After completing Module 7, the learner should be able to: Identify common psychological responses to learning about T1D risk. Recognize common barriers to engaging in screening for islet autoantibodies and/or engaging in early-stage T1D monitoring programs. Describe strategies for addressing needle anxiety.

CONTENT Monitoring guidelines based on stage of T1D Methods for monitoring glycemic changes – Hemoglobin A1c – Oral glucose tolerance test (OGTT) – Home finger-stick glucose testing – Continuous glucose monitors (CGM) Monitor ketone levels Support resources through ASK and Ask the Experts ————— LEARNING OBJECTIVES After completing Module 8, the learner should be able to: Name factors which contribute to the determination of monitoring intensity in islet autoantibody positive individuals. Name methods for evaluating for dysglycemia in early-stage (presymptomatic) T1D. Name symptoms of hyperglycemia and identify the symptoms that should prompt the person to access care immediately.

CONTENT Informing Health Care Staff About FDA Approved Treatments to Delay T1D Teplizumab Early T1D Clinic at the Barbara Davis Center for Diabetes ————— LEARNING OBJECTIVES After completing Module 9, the learner should be able to: Describe the clinical trial findings leading to approval of teplizumab to delay the onset of Stage 3 T1D. Describe current eligibility criteria for teplizumab therapy. Name the most common and most serious serious side effects of teplizumab therapy.

CONTENT Providing Health Care Professionals with Information Regarding Clinical Trials and Available Resources. Introduce history of research to delay or prevent T1D Current clinical trials Resources ————— LEARNING OBJECTIVES After completing Module 10, the learner should be able to: Recognize the pivotal role of clinical trials in contributing data to inform current and future approaches to intervene in the early stages of T1D. Name a resource for learning about ongoing clinical trials in the US.

CONTENT Key screening and monitoring activities Clinical contexts for screening: Endocrinology sub-specialist vs. primary care clinic Key aspects of healthcare system or health clinic’s infrastructure ————— LEARNING OBJECTIVES After completing Module 11, the learner should be able to: Name key health system activities composing a screening program for early-stage (presymptomatic) T1D. Identify elements of healthcare quality to be considered in establishing a screening and monitoring program. Discuss elements of healthcare infrastructure needed for a screening and monitoring program.