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International Consensus Guidance on Early-Stage Type 1 Diabetes Monitoring and Care

Core Concepts
Healthcare providers should partner to provide comprehensive monitoring, education, and psychosocial support for individuals identified as at-risk or in early stages of type 1 diabetes.
This international consensus statement provides guidance for primary care and endocrinology providers on the care and monitoring of people who are at high risk for type 1 diabetes (T1D). The document addresses the care of both children and adults who have undergone screening and tested positive for one or more T1D-associated islet autoantibodies, classified as Stage 0 (single autoantibody), Stage 1 (two or more autoantibodies with normoglycemia), and Stage 2 (two or more autoantibodies with dysglycemia). The key recommendations include: Primary care providers and endocrinologists should partner to care for people who are T1D autoantibody–positive. People with early-stage T1D should have periodic medical monitoring, regular glucose testing, education about diabetes and diabetic ketoacidosis (DKA) symptoms, and psychosocial support. People with Stage 2 T1D should be offered trial participation or approved therapies, such as teplizumab. All healthcare professionals involved in monitoring and care have a responsibility to provide education. Separate guidance is provided for monitoring children, adults, and pregnant women in each stage. The recommendations cover when to start insulin and how to provide education and psychosocial support. The consensus was developed by a panel of 60 experts from 11 countries, led by Breakthrough T1D, in collaboration with several major medical associations. It aims to fill a gap in clinical guidance for the care of individuals identified as at risk or in early stages of T1D through screening programs.
"This is not guidance around who to screen or when to screen. This is guidance for the hundreds of thousands of people around the world who have participated in screening, mostly through research programs, and have been identified with positive autoantibodies and need care in the clinical setting." "Starting October 1, 2024, three new ICD-10 codes will be available for early-stage T1D under subcategory E10-A: E10-A0 for unspecified presymptomatic T1D, E10-A1 for Stage 1, and E10.A2 for Stage 2."
"Type 1 diabetes has a preclinical stage during which careful and specific monitoring can accomplish important goals. Specifically, those goals are that such monitoring can decrease the likelihood of the person developing diabetic ketoacidosis [DKA] and can help determine which patients are candidates for new therapies that may delay the onset of T1D." "This consensus guidance is an important step forward in the field. It details the steps needed by healthcare professionals, teams, and health systems to support and care for individuals identified as at risk for type 1 diabetes during screening. The emphasis on a multidisciplinary approach, the inclusion of primary care, psychosocial support and education is key."

Deeper Inquiries

How can healthcare systems and providers best implement this guidance to ensure equitable access and support for all individuals identified as at-risk or in early stages of type 1 diabetes?

To ensure equitable access and support for individuals identified as at-risk or in early stages of type 1 diabetes, healthcare systems and providers can implement the guidance by: Multidisciplinary Approach: Adopting a multidisciplinary approach involving primary care providers and endocrinologists to provide comprehensive care. Regular Monitoring: Ensuring regular monitoring for individuals with T1D autoantibodies, including glucose testing, education on diabetes symptoms, and psychosocial support. Education and Support: Providing education and psychosocial support to individuals and their families to enhance understanding and coping mechanisms. Trial Participation: Offering trial participation or approved therapies for individuals in Stage 2 T1D to explore treatment options. Clear Communication: Establishing clear communication channels between healthcare providers and patients to facilitate shared decision-making and adherence to treatment plans. Integration of Guidelines: Integrating the guidelines into clinical practice protocols and electronic health records to streamline care delivery and monitoring.

What are the potential ethical and privacy considerations around widespread screening for type 1 diabetes autoantibodies, and how can they be addressed?

Potential ethical and privacy considerations around widespread screening for type 1 diabetes autoantibodies include: Informed Consent: Ensuring individuals understand the purpose, risks, and benefits of screening before participation. Confidentiality: Safeguarding the privacy of individuals' health information and test results to maintain confidentiality. Genetic Information: Addressing concerns related to genetic information and potential discrimination based on test results. Equity: Ensuring equitable access to screening for all individuals, regardless of socioeconomic status or background. Data Security: Implementing robust data security measures to protect sensitive health data from breaches or unauthorized access. These considerations can be addressed through: Ethics Committees: Establishing ethics committees to review screening protocols and ensure adherence to ethical standards. Patient Education: Providing clear information to individuals about the implications of screening and their rights regarding privacy and consent. Legal Frameworks: Adhering to legal frameworks governing the collection, storage, and sharing of health data to protect individuals' rights. Training: Providing healthcare providers with training on ethical guidelines and privacy regulations to uphold patient confidentiality and autonomy.

What advancements in predictive biomarkers or preventive therapies are on the horizon that could further transform the clinical management of early-stage type 1 diabetes?

Advancements in predictive biomarkers and preventive therapies that could transform the clinical management of early-stage type 1 diabetes include: Biomarker Research: Ongoing research to identify novel biomarkers that can predict the progression from at-risk stages to clinical T1D with higher accuracy. Immunomodulatory Therapies: Development of immunomodulatory therapies that target the autoimmune process in early-stage T1D to delay or prevent disease onset. Personalized Medicine: Advancements in personalized medicine approaches to tailor treatment strategies based on individual risk profiles and genetic markers. Regenerative Medicine: Exploration of regenerative medicine techniques to restore beta cell function in individuals with early-stage T1D. Digital Health Tools: Integration of digital health tools for remote monitoring and management of individuals in early-stage T1D to enhance personalized care. These advancements hold the potential to revolutionize early-stage T1D management by enabling targeted interventions, improving outcomes, and ultimately shifting the paradigm towards proactive and preventive healthcare.