1. Updates 

  • Manuscript Submission: Final feedback is due September 2. Dr. Jacobsen plans to submit the manuscript on September 2 or 3.

  • Measures / Data Specification: Revisions were collected through August 31. The team is currently conducting an internal review. A second meeting with the small data working group will be needed to make final decisions, tentatively between September 9–21. Final version release is planned for October 1.

  • White Paper: Final release is planned for September 16. 

2. Sanofi Proposal & Learning Session Planning 

  • The group discussed how to use the Beta Cell Preservation work group time during the November Learning Session to plan next steps for the Sanofi proposal.

  • The Sanofi application was submitted on September 1.

  • The goal is to have an official proposal available by the Learning Session and use the meeting to discuss practical considerations for implementation.

  • The proposed work group meeting during the Learning Session is: Wednesday, November 11, 12:30–2:00 PM

  • Zoom participation will be available for those unable to attend in person 

Potential One-Year Grant 

  • The group discussed planning for a potential one-year grant and identifying participating centers.

  • Survey interest and capacity among centers prior to the Learning Session.

  • A Qualtrics survey will be distributed before the Learning Session.

  • The anticipated start date for Sanofi funding is January 2027.

Alignment with 4T and Screening Initiatives

  • There is significant overlap between the 4T and Screening centers.

  • The group agreed that it would make sense to align the two initiatives where appropriate.

  • Centers that are not currently part of 4T could also potentially be included.

  • It would be valuable to continue conversations in both the 4T and Screening spaces. 

3. New-Onset Stage 3 Teplizumab Implementation

  • The group discussed the current state of new-onset Stage 3 teplizumab implementation across centers.

  • There is currently limited information about how centers are implementing and following patients after new-onset Stage 3 teplizumab.

  • An early portion of the Learning Session meeting could be used to discuss the current state of implementation over the previous 90 days, including what centers are doing and where gaps remain. 

Documentation & Follow-Up 

  • Epic SmartForms may help streamline documentation and allow information to flow into clinical notes.

  • However, there is currently no standardized approach for following patients after Stage 3 teplizumab treatment.

  • Important areas for follow-up include: Patient outcomes, laboratory testing, C-peptide monitoring, other measures of treatment response and follow-up 

Example: University of Florida (UFL) 

  • UFL follows patients for 24 months following treatment.

  • C-peptide is assessed every 6 months.

  • Follow-up includes a 90-minute stimulated (Boost) test and C-peptide measurement every 6 months. 

4. Next Steps 
  • Learning Session Work Group: Develop a draft agenda for the November Beta Cell Preservation work group meeting.
  • Meeting Logistics: Send a calendar invite/save-the-date for the Beta Cell Preservation meeting on Wednesday afternoon during the Learning Session. (in-person and virtual invite)
  • Center Survey: Develop and distribute a Qualtrics survey to assess center interest and capacity prior to the Learning Session.