- Lydia and Lauren provided an update that the manuscript is currently being reviewed by the Publications Committee.
- Reviewer feedback has been received.
- Dr. Broome is incorporating minor reviewer edits.
Next Steps & Timeline
- The proposed Beta Cell data elements were shared with members of the Beta Cell group and the Data Governance and Data Science Committee on August 4 for review.
- Feedback has been requested by August 17.
- Edits will be incorporated internally following the review period.
- The goal is to share an updated version with the broader group in early September.
Implementation
- The Beta Cell elements will be incorporated into a Beta Cell-specific sheet and made available for data mapping ahead of the next data specification release.
- It is anticipated that clinics joining the new special project [TBD] will prioritize documenting and reporting these data elements.
Inpatient Documentation of DMT Discussions
Dr. Demeterco-Berggren proposed a discussion regarding the need for a reliable inpatient method to monitor and document that all newly diagnosed patients with T1D ages 8–17:
- Have been informed about the new disease-modifying therapy (DMT) indication; and
- Have been offered additional information if interested.
- Rady is currently offering a telehealth visit approximately one week after diagnosis to discuss DMT.
Stage 3 SmartForm Considerations
Dr. Jacobsen asked Texas Children's Hospital (TCH) whether there are plans to create a separate Stage 3 DMT Epic SmartForm.
Discussion points included:
- TCH could create a new/separate SmartForm for Stage 3, given that Stage 2 and Stage 3 represent two distinct patient cohorts.
- The Stage 3 form could initially focus on teplizumab, with the ability to add other therapies (e.g., verapamil) in the future.
- Alternatively, Stage 2 and Stage 3 could be incorporated into two separate sections of the same SmartForm using branching logic within Epic.
- A consideration with using the same SmartForm is that all information would flow into the same registry, which could make it more difficult to distinguish Stage 2 from Stage 3 data.
- The group discussed the need to consider inpatient versus outpatient workflows.
- The SmartForm should clearly distinguish between the date of diabetes diagnosis and the date of T1D antibody detection.
- Separate forms would be acceptable if they are easily accessible and clearly labeled.
- The distinction between Stage 2 and Stage 3 should be made early in the workflow.
- Dr. DeSalvo and Lauren will speak with their Epic contact to gather additional information and explore available options.
- The group should explore approaches that can work across different centers rather than requiring one standardized workflow.
The group also discussed:
- Which SmartForm elements could potentially be extracted through other methods.
- The importance of capturing actionable information without creating an excessive documentation burden.
- Dr. Demeterco-Berggren's previous experience avoiding SmartForms while still embedding important data directly into/from Epic was raised as a potential model for consideration.
- The group discussed whether information could eventually be extracted from AI-generated clinical notes.
- The data specification should remain thoughtful and focused; additional elements can be added over time as needed.
- The Stage 3 SmartForm should be narrowed to the most essential elements, with a selective approach to documentation requirements.
The group discussed the July meeting with Sanofi and the key takeaways for a potential funded initiative.
Overall Direction
- Sanofi expressed enthusiasm about the work and confidence in the direction of the initiative.
- Sanofi emphasized the importance of sustainability and indicated that the work should lead with Stage 3 use cases to make the initiative financially viable and justify the investment.
- Stage 3 billing could potentially help build stronger infrastructure to support Stage 1 and Stage 2 work.
- A potential funded proposal would focus on:
- Developing safe, effective, and equitable intervention strategies for high-performing centers.
- Identifying effective approaches for administering and monitoring teplizumab.
- Focusing the initial aims and objectives on Stage 3 interventions.
- Providing FTE support to participating clinics, including support for an MD and coordinator/navigator.
Timeline & Scale
- The team plans to establish outcomes and accomplishments for 2027.
- An implementation meeting is anticipated for December 2026 to begin planning and prepare for the initiative.
- Formal funding would begin after January 1, 2027.
- The scale of funding has not yet been determined.
- The current hope is that approximately 10 additional centers could join the initiative.
- The team will provide an update on next steps and communicate if any materials or information are needed from participating centers.
- Dr. Alonso suggested documenting reasons why planned activities were not completed, including any logistical barriers.
- Dr. Broome noted that he has a separate Implementation Science Aims page that could be shared and may help support the development of these ideas.
- Beta Cell/Data Specification: Members to provide feedback on the proposed data elements by August 17.
- Beta Cell/Data Specification: Incorporate feedback and prepare an updated version for sharing in early September.
- Epic/SmartForm: Dr. DeSalvo and Lauren to consult with their Epic contact regarding options for Stage 2/Stage 3 SmartForm development and data extraction.
- SmartForm: Continue exploring approaches that minimize documentation burden while capturing essential, actionable information.
- Sanofi Proposal: Continue developing potential Stage 3-focused aims, objectives, outcomes, and implementation strategies.
- Sanofi Proposal: Plan for an implementation meeting in December 2026.
- Implementation Science: Dr. Broome to share the separate Implementation Science Aims page for consideration.
- Funding: Provide additional guidance to centers as the scope and requirements of the potential 2027 initiative become clearer.