{
  "abstract": "Objective This pilot project served as a proof of concept to assess the operational feasibility of integrating presymptomatic type 1 diabetes screening and monitoring, using islet autoantibody (AAB) testing, into routine clinical care at two pediatric T1D Exchange Quality Improvement Collaborative (T1DX-QI) centers. Additionally, it identified care team perceptions of operational challenges and surveyed healthcare teams’ readiness in the T1DX-QI.Research design and methods Over an 18-month period, this initiative focused on developing and optimizing workflows, provider and patient education, technological integration, and health equity, utilizing quality improvement methodologies. Focus groups were conducted to identify care team perceptions of operational challenges via Zoom. Prior to project start, a cross-sectional survey was administered among T1DX-QI centers to assess screening and monitoring readiness.Results Workflows for screening and monitoring were tested over time at the two centers, both developing process maps. A total of 147 individuals were screened during 12 months of active screening. No episodes of diabetes-related ketoacidosis were reported among those screened with confirmed positive results. Key facilitators of implementation identified during focus groups included enhanced interdisciplinary communication, streamlined insurance processes, and improvements to electronic health record systems. Challenges included limited clinical resources, variable patient engagement, and inconsistent insurance coverage. Readiness survey results highlighted that pediatric centers were twice as likely to conduct screening and reported greater access to results from research screening programs.Conclusions Findings from this pilot offer critical insights into the practical implementation of presymptomatic type 1 diabetes screening and monitoring programs in diverse clinical environments. Despite identified barriers, continuous quality improvement efforts, along with identified facilitators to success, led to an increase in the number of individuals screened and monitored. Future work will focus on expanding these efforts across diverse care settings, with strategies to support sustainability beyond pilot phases.",
  "authors": [
    {
      "affiliations": [
        "Rady Children’s Hospital, University of California San Diego, San Diego, California, USA"
      ],
      "name": "Carla Demeterco-Berggren"
    },
    {
      "affiliations": [
        "Quality Improvement, T1D Exchange, Boston, Massachusetts, USA"
      ],
      "name": "Emma Ospelt"
    },
    {
      "affiliations": [
        "Quality Improvement, T1D Exchange, Boston, Massachusetts, USA"
      ],
      "name": "Trevon Wright"
    },
    {
      "affiliations": [
        "Quality Improvement, T1D Exchange, Boston, Massachusetts, USA"
      ],
      "name": "Nicole Rioles"
    },
    {
      "affiliations": [
        "Quality Improvement, T1D Exchange, Boston, Massachusetts, USA"
      ],
      "name": "Don Buckingham"
    },
    {
      "affiliations": [
        "Quality Improvement, T1D Exchange, Boston, Massachusetts, USA"
      ],
      "name": "Ann Mungmode"
    },
    {
      "affiliations": [
        "Quality Improvement, T1D Exchange, Boston, Massachusetts, USA"
      ],
      "name": "Osagie Ebekozien"
    },
    {
      "affiliations": [
        "Rady Children’s Hospital, University of California San Diego, San Diego, California, USA"
      ],
      "name": "Christine Byer-Mendoza"
    },
    {
      "affiliations": [
        "Rady Children’s Hospital, University of California San Diego, San Diego, California, USA"
      ],
      "name": "Kimberly McNamara"
    },
    {
      "affiliations": [
        "Rady Children’s Hospital, University of California San Diego, San Diego, California, USA"
      ],
      "name": "Andrea Huber"
    },
    {
      "affiliations": [
        "Pediatric Endocrinology, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Adriana Saldana"
    },
    {
      "affiliations": [
        "Pediatric Endocrinology, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Laura Jacobsen"
    }
  ],
  "full_text": "WHAT IS ALREADY KNOWN ON THIS TOPIC Islet autoantibody (AAB) screening enables the identification of individuals at increased risk for developing stage 3 type 1 diabetes. Early detection, followed by systematic monitoring, offers the potential to initiate timely education, reduce the psychological burden of a sudden diagnosis, and prevent life-threatening complications such as diabetes-related ketoacidosis.WHAT THIS STUDY ADDS The findings from this study offer critical insights into the practical implementation of presymptomatic type 1 diabetes screening and monitoring programs in diverse clinical environments. It highlights key facilitators and barriers to this process.HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE, OR POLICY Future work will focus on expanding these efforts across diverse care settings, with strategies to support sustainability beyond pilot phases, long-term outcomes of monitored individuals, and on ensuring scalable models that provide equitable reach and access to emerging disease-modifying therapies. Widespread clinical adoption of AAB screening and monitoring represents a critical opportunity to shift the type 1 diabetes diagnostic paradigm, from acute symptom-based identification to proactive risk stratification and intervention.Islet autoantibody (AAB) screening enables the identification of individuals at increased risk for developing stage 3 type 1 diabetes before clinical symptoms emerge. Early detection, followed by systematic monitoring, offers the potential to initiate timely education, reduce the psychological burden of a sudden diagnosis, and prevent life-threatening complications such as diabetes-related ketoacidosis (DKA). AAB screening also provides an opportunity to consider therapeutic interventions that may delay disease progression.1–3Since 2024, the American Diabetes Association (ADA) Standards of Care recommend AAB screening for individuals at risk for type 1 diabetes (ie, a family history of type 1 diabetes or elevated genetic risk).4 Teplizumab, an US Food and Drug Administration (FDA)-approved disease-modifying therapy, has been shown to delay the onset of symptomatic type 1 diabetes in adults and children aged 8 years and older with stage 2 presymptomatic type 1 diabetes.5 6 As such, early identification through screening is essential to ensure timely access to this and other emerging therapies. Moreover, population-level studies indicate that widespread screening and follow-up monitoring can reduce DKA rates at diagnosis by up to 90%.2 3 7 However, screening for presymptomatic type 1 diabetes requires a paradigm shift in the field of endocrinology and implementation of new clinical protocols, which can be challenging.This pilot project builds on previous work by the T1D Exchange Quality Improvement Collaborative (T1DX-QI) that explored health professionals’ perspectives regarding AAB screening.8 However, there remains a lack of evidence on how to effectively integrate AAB screening and monitoring into routine clinical practice outside of research environments.9 This study (1) developed and assessed two pediatric diabetes centers’ workflows for AAB screening and monitoring in the real-world setting, (2) identified care team perceptions of operational challenges to the AAB screening and monitoring through qualitative interviews, and (3) surveyed healthcare teams’ readiness to perform AAB screening and metabolic monitoring in the T1DX-QI.Research design and methods Development and assessment of AAB screening and monitoring workflows The study was conducted over an 18-month period, including a 6-month development phase, where quality metrics were developed and current state analyzed, at two pediatric centers. Rady Children’s Hospital, San Diego, and the University of Florida, Gainesville, were chosen for this pilot because of diversity in patient demographics, geography, and prior type 1 diabetes early detection research infrastructure established in the latter but not the former. Quality process interventions were implemented to develop and test diabetes centers’ workflows for AAB screening and monitoring in a real-world setting. Each center developed a modified local type 1 diabetes AAB screening and monitoring protocol, reviewed potential operational changes, and tested interventions to incorporate successful approaches. Four priority domains were identified to guide the Plan-Do-Study-Act (PDSA) improvement cycles: education, workflow, technology, and equity. This study was approved by the WIRB-Copernicus Group, Inc. Institutional Review Board (IRB), 20232106, and informed consent was obtained.Screening occurred at the two pediatric centers over a 12-month period, with a focus on children and young adult first-degree relatives of patients with type 1 diabetes who were existing patients at each center. Aggregate data (online supplemental table 1) were shared monthly with the T1DX-QI coordinating center, including diabetes diagnosis type, follow-up monitoring, and health metrics (DKA events and HbA1c). More detailed metrics were collected and aggregated for those who were positive for multiple AAB including AAB type, type 1 diabetes stage at initial assessment, and interventions offered to them based on eligibility criteria. Run and statistical process control charts were plotted to observe trends and shifts.SP310.1136/bmjdrc-2026-005980.supp3Supplementary dataTesting for the four biochemical islet AAB was conducted using venous blood at local hospital laboratories (eg, radiobinding assay (RBA)), commercial laboratories (eg, enzyme-linked immunosorbent immunoassay), and via point-of-care testing (POC with screening kits kindly provided by the Barbara Davis Center for Diabetes Autoantibody Laboratory with initial screen via electrochemiluminescence assay with confirmation on venous sample via RBA).10 Metabolic staging and monitoring were conducted using POC HbA1c (DCA Vantage Analyzer), commercial laboratory HbA1c, glucose, and C-peptide testing (eg, as part of an oral glucose tolerance test (OGTT)), and home glucometers and continuous glucose monitors (CGMs). Visits were conducted in person or via telemedicine.Qualitative interviews identifying care team perceptions of operational challenges Two, 60-minute focus groups were conducted by a research scientist (EO) experienced in qualitative research and attended by a research team member (TW) from T1DX-QI with the participating pediatric centers via Zoom, to discuss their real-world experience implementing screening and monitoring in their centers. The Consolidated Framework for Implementation Research was used as a guide to inform the focus group guide. 11 Audio recordings from the two focus groups were transcribed using TranscribeMe and exported into NVivo 13 (V.1.7.2) for data organization and management. Each transcript was reviewed by EO and analyzed to identify the key themes and topics of interest. Themes were developed using a mix of deductive and inductive coding. Key themes, along with any discrepancies in coding, were resolved among the authors (EO, TW, and NR). This study adhered to the Consolidated Criteria for Reporting Qualitative Research (COREQ) standards, shown in online supplemental table 2.SP410.1136/bmjdrc-2026-005980.supp4Supplementary dataT1DX-QI collaborative survey of AAB screening and monitoring readiness A cross-sectional survey was administered to US diabetes centers participating in the T1DX-QI to evaluate current practices related to type 1 diabetes screening and monitoring.Results Development and assessment of AAB screening and monitoring workflows Workflows for screening and monitoring were tested over time at the two participating centers, employing quality improvement tools such as fishbone diagrams and process maps (aggregated process map in online supplemental figure 1).SP110.1136/bmjdrc-2026-005980.supp1Supplementary dataProviding structured education on screening and monitoring for individuals living with type 1 diabetes and their families, and for providers, was crucial to the implementation of this project. Please refer to the online supplemental materials to review an example of educational materials provided. Educational efforts targeted both families and healthcare professionals. Families were counseled on the benefits of screening and longitudinal monitoring, whereas healthcare professionals received training on type 1 diabetes staging, recommended monitoring strategies, and potential interventions, including FDA-approved disease-modifying therapies and currently active clinical trials. Various instructional delivery modes were tested and modified based on feedback through tests of change. Teams developed standard operating procedures for creating new records in the electronic health record (EHR) database, ordering relevant laboratory tests, training new staff, tracking insurance denials, and clinic visit reimbursement. Centers communicated with insurers and developed a letter of medical necessity for AAB testing and monitoring. Additionally, centers created multimodal education on type 1 diabetes AAB screening and monitoring for patients and families, including added information to new onset type 1 diabetes binders, flyers, and electronic messages through the patient portal.SP210.1136/bmjdrc-2026-005980.supp2Supplementary dataIntegrating screening and monitoring into an existing workflow was another important target area. Workflow-related improvement efforts centered on creating and implementing standardized protocols for screening and monitoring, along with streamlined follow-up procedures to promote timely and coordinated patient care. Other examples include creating a new referral code for type 1 diabetes screening and monitoring to avoid longer waitlists than a typical diabetes clinic, increasing the number of appropriate Early-Stage Clinic visits (in-person and virtual) from the referral pool, and creating dedicated screening and monitoring appointment visits. Periodic electronic patient portal messages were sent to families of patients living with type 1 diabetes to inform them of screening for relatives.Technology-related tests of change targeted ways to improve the efficiency of using technology in clinic (such as using the EHR system itself) related to screening and monitoring, and patient-related technology. Examples of these included creating type 1 diabetes flowsheets and forms within the EHR systems, facilitating referral and scheduling mechanisms, and creating a new clinic note template. Other modifications included increasing the availability of POC islet AAB screening and monitoring kits in the outpatient diabetes clinic, optimizing the number of blood collection tubes needed for blood draws, and having CGM samples available for individuals diagnosed with presymptomatic stage 2 type 1 diabetes. Centers ensured that care team members consistently provided patients with information about relevant research trial opportunities when available.Health equity-focused tests of change prioritized advocacy for equitable access to screening, care, and treatment resources. Centers strengthened patient support by assisting families in navigating insurance coverage through letters of medical necessity and by producing culturally and linguistically tailored educational materials for screening and monitoring. To address structural barriers to participation, centers also implemented weekend screening opportunities at both clinical and community sites to improve access for families unable to attend weekday appointments.Over the course of the project, there were a total of 147 individuals screened across both centers in 12 months of active screening (figure 1). This population was made up of mostly children and young adult first-degree relatives of patients with type 1 diabetes who were existing patients at each center. The majority of individuals self-identified as non-Hispanic white (46%), followed by Hispanic (24%). Overall, 58% of participants were covered by private insurance (online supplemental table 2).Figure 1Number of individuals screened at both centers (Rady Children’s Health, San Diego and University of Florida) combined by month during the pilot project period.The number of individuals monitored per the recent consensus guideline2 (figure 2) was tracked over time. During screening, 54% of individuals with confirmed positive multiple autoantibodies presented in stage 1 with normal blood glucose levels, 38% presented in stage 2 with abnormal glucose tolerance on OGTT or an HbA1c between 5.7% and 6.4%, and 8% presented in stage 3 with blood glucose levels above ADA diagnostic thresholds.12 In addition, 100% of confirmed AAB positive individuals had no documented DKA event during the pilot observation period. All screened individuals that received confirmed positive results for autoantibodies were offered a follow-up visit scheduled according to the new consensus guidance for monitoring pre-stage 3 type 1 diabetes,2 and of those, 81% elected to proceed with monitoring and had a follow-up visit scheduled. Teplizumab was offered to all individuals who met eligibility criteria; among the five eligible participants, one accepted treatment. Eligible participants were also offered enrollment in available clinical research trials. Owing to the limited availability of such trials during the screening period, 33% of eligible individuals were offered participation, and 14% elected to enroll.Figure 2Number of confirmed autoantibody positive individuals undergoing metabolic monitoring at both centers (Rady Children’s Health, San Diego and University of Florida) during the pilot project period. Vertical bar graphs indicating the absolute number monitored per month with the line indicating the aggregate number monitored over time.Care team perceptions of operational challenges to the implementation of AAB screening and monitoring Six members of the healthcare teams, including endocrinologists, nurse educators, and clinical research coordinators, directly involved in the project, participated in the two focus groups. At both participating centers, pediatric endocrinologists served as the lead implementers. At Center 1, the endocrinologist performed the actual screenings, with significant support from program coordinators who assisted with recruitment, chart creation, and lab ordering. In contrast, Center 2 had resources to adopt a more collaborative planning model, with nurse educators conducting the screenings and the endocrinologist focusing on follow-up and monitoring.Barriers to implementation Clinic operational barriers Both centers reported limited staffing and physical space as major challenges to conducting screenings ( figure 3). Time constraints during regular clinic appointments made it difficult to incorporate screening discussions and procedures. Additionally, for family members who are not existing patients, creating new medical records was often cumbersome and delayed workflow. Other operational issues included difficulties with ordering labs, especially when reliant on external screening programs, which often led to delays or cumbersome resulting and documentation processes. Participants also noted confusion around billing procedures, insurance coverage, and laboratory processing logistics.Figure 3Barriers to implementing a screening and monitoring program identified during focus groups.Patient-related barriers Patient-related challenges included a general reluctance or delay in following through with screening, especially if it was not conducted during the initial visit. Many families expressed concerns about insurance coverage, out-of-pocket costs, and the long-term implications of a positive result on their child’s insurability. Additionally, a lack of education and understanding about the importance and benefits of early screening reduced urgency and willingness to participate.Barriers to monitoring Many of the barriers to monitoring mirrored those encountered during screening, namely, limited time, staffing, and physical space.It’s a little more labor-intensive than just antibodies, because it’s timed lab results with a drink. (Pediatric Endocrinologist)However, an additional and growing challenge was communicating with families once positive results were received and getting them to return for follow-up confirmatory testing and ongoing monitoring. This highlighted the need for structured outreach strategies and more flexible scheduling options.Facilitators and solutions Despite the barriers, several key facilitators supported successful implementation. Highly motivated and engaged staff were crucial for initial buy-in and ongoing momentum. Educational materials, such as flyers, handouts, and electronic patient portal messages, helped inform families and increase participation. Screening events held on weekends or during diabetes camps were effective in reaching families who could not attend regular appointments. Workflow improvements such as access to in-clinic POC screening kits for one center or optimized venous blood volume collection at another helped standardize laboratory processes and reduce errors. Establishing an early diabetes clinic and dedicated email address further facilitated follow-up care and streamlined timely scheduling for individuals requiring monitoring visits.Surveyed healthcare teams’ readiness to perform AAB screening and metabolic monitoring in the T1DX-QI collaborative In October 2024, 56 of 62 centers (38 pediatric, 18 adult) completed the readiness survey, yielding a 90% response rate. Pediatric centers were twice as likely as adult centers to conduct type 1 diabetes AAB screening. A higher proportion of pediatric centers also reported monitoring individuals identified as at-risk using glucose-based assessments (self-monitoring of blood glucose, OGTT, and HbA1c) and, when available, CGM ( figure 4). Several regulatory and operational limitations were identified that may restrict the ability of centers, particularly adult diabetes programs, to order laboratory tests for individuals not directly under a healthcare professional’s care (eg, relatives of individuals with type 1 diabetes). Among respondents managing individuals with stage 2 type 1 diabetes (multiple autoantibodies and dysglycemia), 75% indicated that offering participation in relevant clinical trials or FDA-approved disease-modifying therapies was ‘easy’ or ‘somewhat easy’. Pediatric practices also reported greater access to results from research screening programs (eg, TrialNet, ASK) compared with adult practices (71% vs 39%, respectively). These findings informed subsequent PDSA cycles aimed at addressing identified gaps in screening, monitoring, and equitable access across participating centers.Figure 4Respondents from 56 US diabetes centers (38 pediatric and 18 adult endocrinologists) answered the following survey questions: (A) Does your center currently screen individuals at risk for developing type 1 diabetes? Does your center have a monitoring program for individuals that screen positive for type 1 diabetes autoantibodies? (B) Does your center document autoantibody screening data in the electronic health record (EHR)? Does your center document data on autoantibody monitoring in the EHR? (C) In your state/health system, do you need a primary care professional (PCP) referral before you can order labs, schedule a clinic visit, or create a medical record number for a new patient who does not have a preferred provider organization? In your state/health system, can you order commercial labs (eg, islet autoantibodies) on patients that are not under your care (eg, siblings of your patients)? (D) For patients with stage 2 type 1 diabetes, how easy is it for your center to offer participation in appropriate trials or approved therapies?Conclusions Even among well-established clinical centers in the T1DX-QI, there is an incomplete uptake of type 1 diabetes AAB screening and monitoring, with less uptake in adult centers compared with pediatric centers. While pediatric centers are conducting more type 1 diabetes screening and monitoring, likely due to a larger portion of their patient base having type 1 diabetes (as compared with type 2 diabetes, for example), there are still many centers that are facing barriers to screening and monitoring. These insights highlight existing gaps and the need for targeted strategies to enhance screening accessibility and monitoring across healthcare systems. Accordingly, these findings informed the objective of this proof-of-concept study, which was to identify and develop pragmatic implementation strategies to support real-world delivery of type 1 diabetes islet AAB screening and evidence-based metabolic monitoring.Screening for type 1 diabetes within clinical care appears to be more racially and ethnically aligned with the US population of people with type 1 diabetes (ie, non-Hispanic white individuals made up 49% of those screened at the two centers). In a current large screening program of relatives with type 1 diabetes, as with most research programs in type 1 diabetes, there remains a disproportionally high frequency of people who self-report as non-Hispanic white (86–88%) compared with the US disease prevalence in this population (72%).13 14 This suggests that embedding screening into routine care may improve equity and access to early-stage diagnosis and intervention opportunities.The multicenter survey is limited by a likely selection bias and may not represent all centers that care for people with type 1 diabetes. Regarding the rate of AAB positivity reported in this pilot, there is a presumed ascertainment bias, as we would not get referred negative results from the community. Additionally, data on the number of individuals who declined screening were not collected, as the resources required to collect this information were not available.Although screening and monitoring were achieved in real-world settings, key operational challenges were identified. These included limited clinical capacity, variability in insurance coverage, lack of standardized workflows, and inconsistent patient engagement. Such barriers have previously been reported as significant obstacles to translating screening from research environments into clinical practice.6–8 Monitoring required greater staffing support and follow-up coordination, consistent with recent consensus statements emphasizing the need for resource-intensive care models for individuals in stages 1 and 2 of type 1 diabetes.2 3Importantly, all individuals with confirmed multiple AAB positivity were offered clinical monitoring, and the majority accepted. Eligible individuals in stage 2 type 1 diabetes were also offered treatment with teplizumab, and a subset participated in clinical trials. These findings suggest that when screening and monitoring are embedded into clinical workflows, they can enable timely identification, staging, and management in accordance with national guidelines.2 3 5Broader implementation across US healthcare systems will require coordinated efforts to address key structural factors, including reimbursement models, care delivery capacity, and the development of standardized protocols for patient and family engagement. Our findings highlight the importance of interdisciplinary collaboration, iterative testing, and adaptive implementation approaches to address system-level and patient-level barriers in real time. This is particularly relevant as the field moves toward broader, population-based screening for type 1 diabetes, including calls for universal screening regardless of family history.15 While universal screening promises to improve early identification and reduce rates of DKA at diagnosis, it also poses new demands on healthcare systems. Specifically, our findings highlight the need to build and support specialty hubs, typically located within endocrinology or pediatric diabetes programs, that can manage referrals for staging, metabolic monitoring, and treatment consideration in alignment with emerging national standards.16 Without this referral infrastructure within clinical care, screening alone may not improve outcomes or equitably connect families to evidence-based care and clinical trials.In summary, this pilot validates the efforts to integrate presymptomatic type 1 diabetes screening and monitoring into clinical care and provides a practical framework for doing so. Major successes of this project include addressing barriers, supporting patients with new diagnoses, and no observation of individuals presenting in DKA at diagnosis. Future work is focusing on expanding these efforts across diverse care settings, with strategies to support sustainability beyond pilot phases, long-term outcomes of monitored individuals, and on ensuring scalable models that provide equitable reach and access to emerging disease-modifying therapies. Widespread clinical adoption of AAB screening and monitoring represents a critical opportunity to shift the type 1 diabetes diagnostic paradigm, from acute symptom-based identification to proactive risk stratification and intervention.",
  "title": "Bringing early detection to life: real-world operationalization of a presymptomatic type 1 diabetes screening and monitoring pilot program",
  "uid": "048f15d0-35e5-544e-9c4c-1d62ba912b6a"
}