Summary
What is this summary about?
This is a plain language summary of a survey on experiences and views of (1) adults who were treated with teplizumab in early type 1 diabetes (T1D) and (2) caregivers of children who were treated with teplizumab in early T1D.
Teplizumab is a treatment currently approved to delay the onset of stage 3 T1D in adults and children aged 8 years and older with stage 2 T1D.
The survey collected information on:
Characteristics and personal and family health history of the respondents.
Experiences with finding out they or the child they care for had early T1D (screening and diagnosis).
Thoughts and feelings before and after receiving treatment with teplizumab.
Expectations for future health.
This survey is the first to ask about the real-world experiences (outside of a clinical trial) of adults treated with teplizumab and caregivers of children treated with teplizumab.
What were the results?
Most people agreed with the statement that they were grateful for the chance to receive teplizumab (or for the child they care for to receive teplizumab).
Most people also thought teplizumab would make their T1D easier to manage.
Most people still worried about their condition getting worse and kept a close eye on their glucose levels after treatment with teplizumab.
Even though they were concerned, they would recommend teplizumab to others and make the same decision for treatment if another family member had early T1D.
What do the results of the survey mean?
This survey captured the experiences and views of adults who received teplizumab or caregivers of children who received teplizumab. These findings are important for people who are considering screening for T1D or treatment with teplizumab, people who want to understand the possible consequences of having a screening test result showing early T1D, and clinicians who are considering teplizumab for their patients.
Keywords: type 1 diabetes, experience, feelings, screening, teplizumab
Acknowledgments
The authors thank Charlotte Singh, MD, CMPP™ (Sanofi), for coordinating manuscript development, facilitating author discussions, and providing a critical review of this manuscript.
Footnotes
Ethics approval and consent to participate: The study complied with the principles of the Declaration of Helsinki. Institutional Review Board (IRB) approval for the study was obtained from the Western Institutional Review Board Copernicus Group (20243185 #41276324.0). Participants provided written informed consent prior to participating in this study.
Author contributions: Conceptualization; writing – review and editing: Holly K. O’Donnell, Kimber M. Simmons, Stephen E. Gitelman, Terry Dex, Mattias Wieloch, Julia Zaccai and Korey K. Hood. Formal analysis; writing – review and editing: Robert Hill. Methodology; formal analysis; writing – review and editing: Jennifer D’Souza. Methodology; writing – review and editing: France Ginchereau Sowell and James Turnbull.
Funding: This survey was funded by Sanofi. Medical writing support was provided by Christina Oh, PharmD, Lauren Poppi, PhD, and Ann E. Todd, PhD, CMPP™, of IMPRINT Science, New York, NY, USA, and was funded by Sanofi.
Competing interests: Holly K. O’Donnell has served on an advisory board and as a consultant for Sanofi and has received support from the National Institutes of Health (NIH), Breakthrough T1D, and The Helmsley Charitable Trust for research studies. Kimber M. Simmons has served on advisory boards for Provention Bio, Sanofi, and Shoreline Biosciences and has received support from the NIH, Breakthrough T1D, Provention Bio, and Sanofi for roles as an investigator in clinical trials. Stephen E. Gitelman has served on advisory boards for Abata Therapeutics, Genentech, GentiBio, Provention Bio, SAB Biotherapeutics, Sana Biotechnology, Sanofi, and Shoreline Biosciences; has received support from the NIH, Provention Bio, and Sanofi for roles as an investigator in clinical trials; and serves on data and safety monitoring boards for Diamyd Medical, Breakthrough T1D, and INNODIA. Terry Dex, Mattias Wieloch, and Julia Zaccai are employees of Sanofi and may hold stock in Sanofi. Robert Hill is an employee of Cytel and was on contract with Sanofi at the time of this study. Jennifer D’Souza, France Ginchereau Sowell, and James Turnbull are employees of IQVIA and may hold stock in IQVIA. Korey K. Hood has received consulting fees from Sanofi, Havas Health, and MannKind and received a research grant from Embecta.
Availability of data and materials: Qualified researchers may request access to data. Further details on Sanofi’s data sharing criteria, eligible studies and process for requesting access can be found at: https://www.vivli.org/