TrialNet

Eligibility:

• For Individuals who are 2-45 years of age with a parent, child, brother, or sister with T1D.
• For Individuals who are 2-20 years of age with a niece, nephew, aunt, uncle, grandparent, half-sibling or cousin with T1D.

Or

• Are between the ages of 2 and 45 years and have tested positive for at least one type 1 diabetes related autoantibody outside of TrialNet.
• Have not been diagnosed with diabetes.

Purpose: This study helps to identify family members of people with T1D who might have antibodies associated with T1D. Relatives of people with T1D have a 3-4 percent chance of testing positive for antibodies. If participants are found to be antibody positive they will be offered follow up screening and further tests to determine their risk for T1D. Depending on the outcome of those tests, participants may qualify for prevention studies offered by TrialNet.

For more information visit TrialNet on the web. 

Coordinators:  Juanita O'Brian, CMA, CCRC; Henry Rodriguez, MD

Contact Info:

Email: usfdiabetesresearchc@usf.edu 

Phone Number: (813) 974-9817

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Sanofi

Study Name: EFC18241- The Beta Preserve Study

Eligibility:

• 1-25 years of age
• Recent diagnosis (within a month) of Stage 3 T1D
• Be positive for at least one T1D autoantibody (proteins that attack insulin-making cells by mistake).
• Other criteria applies that the study doctor will determine participant qualification from

Purpose: This study is looking at how an investigational study drug, called Teplizumab, might possibly help protect insulin-producing cells by affecting the immune cells that attack them. The main goal of this study is to see if Teplizumab can work better than a placebo (a look-alike with no medicine in it) in helping people keep their blood sugar in a healthy range or use less mealtime insulin.

For more information visit clinicaltrials.gov ID NCT07088068

Coordinators: Bethany Dunn, BSN, RN

Principal Investigator Henry Rodriguez, MD

Contact Info:

Email: usfdiabetesresearchc@usf.edu / eadunn3@usf.edu

Phone Number: (813) 974-4886

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COUR Pharmaceuticals

Study Name: CNP-103-CL-201

Eligibility:

• 12-35 years of age
• Recent diagnosis (within 180 days) of Stage 3 T1D
• Other criteria applies that the study doctor will determine participant qualification from

Purpose: This study is testing CNP-103, an investigational antigen-specific immune tolerance therapy, for patients recently diagnosed with type 1 diabetes (T1D). The goals of the clinical trial are to see:

• If CNP is safe and well-tolerated
• If CNP-103 can help recently diagnosed patients retain some of their body’s own insulin- producing ability

For more information visit clinicaltrials.gov ID NCT06783309

Coordinators: Bethany Dunn, BSN, RN

Principal Investigator Henry Rodriguez, MD

Contact Info:

Email: usfdiabetesresearchc@usf.edu / eadunn3@usf.edu

Phone Number: (813) 974-4886

Romosozumab for Children and Adolescents with Osteogenesis Imperfecta

Eligibility:

• Ambulatory children and adolescents, age 5 to < 18 years, including ambulatory with assistance as defined in the pediatric OI population
• Confirmed diagnosis of Osteogenesis Imperfecta types 1, 2, or 4
• 3 or more fractures within the previous 2 years, or 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or 2 or more prevalent vertebral fractures.

Purpose: Study to Evaluate Efficacy and Safety of Romosozumab Compared with Bisphosphonates in Children and Adolescents with Osteogenesis Imperfecta

Coordinator: Ponja Hemphill, RN

Contact: CRC-health@usf.edu