Long-Term Outcomes of Teplizumab in Routine Clinical Care (NCT07360080)
🩺 Plain-English Summary (8th-Grade Level)
This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (3 items).
Location: Investigational Site Number: 8400003 — Atlanta, Georgia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria -
- Participants who had participated in a previous clinical trial for teplizumab.
- Participants enrolled in a clinical trial within 6 months prior to study enrollment. (Note: Participants enrolled in other observational studies may be included.) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (10 Sites)
- Investigational Site Number: 8400003 — Atlanta, Georgia
- Investigational Site Number: 8400004 — Atlanta, Georgia
- Investigational Site Number: 8400001 — New York, New York
- Investigational Site Number: 8400002 — Syosset, New York
- Investigational Site Number: 8400005 — Sandy City, Utah
- Investigational Site Number: 3760003 — Petah Tikva,
- Investigational Site Number: 3760002 — Ramat Gan,
- Investigational Site Number: 3760001 — Ramat Gan,
- Investigational Site Number: 7840001 — Abu Dhabi,
- Investigational Site Number: 7840002 — Abu Dhabi,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.