Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

🩺 Protocol Summary

This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.

Primary Research Facility: Diabetes Research Institute (Miami, Florida)

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Type 1 Diabetes Mellitus?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged between 18 Years and 70 Years?

🔍 Protocol Specified Age Range: 18 Years to 70 Years

Able to attend required clinic visits at Diabetes Research Institute (Miami, Florida)?

🔍 Logistical Requirement: Site at Diabetes Research Institute

📍 Primary Site Map

Site: Diabetes Research Institute — Miami, Florida

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.