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Clinical Trials - Adult

Currently Enrolling T1D Studies

TrialNet Logo

Eligibility:

  • For Individuals who are 2.5-45 years of age with a parent, child, brother, or sister with T1D.
  • For Individuals who are 2.5-20 years of age with a niece, nephew, aunt, uncle, grandparent, half-sibling or cousin with T1D.

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: usfdiabetesresearchc@usf.edu | Phone Number: (813) 974-9817

Eligibility:

  • For individuals ages 8-45
  • Diagnosed with Type 1 Diabetes in the last 18 months

Purpose: To identify a safe, metabolically favorable, dosing regimen for siplizumab that induces changes in T cell phenotypes observed with alefacept therapy

Coordinator: Gregory Spires, BSN, RN, CRC

Contact: usfdiabetesresearchc@usf.edu | Phone Number: (813) 974-9536

Eligibility:

  • For individuals ages 6-81 
  • Diagnosed with Type 1 Diabetes
  • Currently using the t:slim X2 pump with Control-IQ technology
  • HbA1c < 10.5%
  • Residing full-time in the United States, with no anticipated travel outside the United States in the next 15 weeks

Purpose: To evaluation the safety of an Advanced Hybrid Closed Loop System Using Lyumjev with the Tandem t:slim X2 with Control-IQ 

Coordinator: Janet Rodriguez, BSN, RN, CDCES, CRA-USF/ADVANCED

Contact: usfdiabetesresearchc@usf.edu | Phone Number: (813) 974-5499

Eligibility:

  • For individuals ages 2 – 21 and 65 – 80
  • Diagnosed with Type 1 Diabetes for at least 3 months
  • Multiple daily injections (MDI)
  • Home computer with internet access
  • Total Daily Dose of insulin (Humalog or Novolog) ≥ 8 units/day

Purpose: The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting.
After-market study of the 770G
1 year randomized first 6 months (current therapy or HCL) followed by 6 months of HCL
Requires Computer & Internet
Pump, sensor, meter and all pump/sensor/testing supplies provided for the duration of the study. 

Coordinator: Janet Rodriguez, BSN, RN, CDCES, CRA-USF/ADVANCED

Contact: usfdiabetesresearchc@usf.edu | Phone Number: (813) 974-5499

Eligibility:

  • For individuals ages 2 – 25
  • Diagnosed with Type 1 Diabetes
  • Spanish speaking

Purpose: To develop a new model of care for Latino patients that will provide them with culturally sensitive care. 

Coordinator: Janet Rodriguez, BSN, RN, CDCES, CRA-USF/ADVANCED

Contact: usfdiabetesresearchc@usf.edu | Phone Number: (813) 974-5499

Currently Enrolling CAH Studies

Eligibility:

  • For individuals ages 18-55
  • History of Congenital Adrenal Hyperplasia due to 21 hydroxylase deficiency
  • Stable glucocorticoid dose for more than 3 months

Purpose: A dose-ranging study to evaluate the efficacy and safety of SPR001 (Tildacerfont) in Adults with Classic Congenital Adrenal Hyperplasia. This medication has not been approved by the FDA.

Coordinator: Gregory Spires, BSN, RN, CRC

Contact: usfdiabetesresearchc@usf.edu | Phone Number: (813) 974-9536

Eligibility:

  • For individuals ages 18-55
  • History of Congenital Adrenal Hyperplasia due to 21 hydroxylase deficiency
  • Stable glucocorticoid dose for more than 3 months

Purpose: To evaluate the efficacy and safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adults with Classic Congenital Adrenal Hyperplasia. This medication has not been approved by the FDA.

Coordinator: Gregory Spires, BSN, RN, CRC

Contact: usfdiabetesresearchc@usf.edu | Phone Number: (813) 974-9536

Currently Enrolling Osteogenesis Imperfecta (OI) Studies

Eligibility:

  • For individuals ages 5 to < 26
  • Confirmed diagnosis of Osteogenesis Imperfecta types I, III, or IV
  • ≥ 1 fracture in the past 12 months or ≥ 2 fractures in the past 24 months  

Purpose: To evaluate the effect of setrusumab vs placebo on reduction in fracture rates, to assess the safety profile of setrusumab, and to evaluate the immunogenicity of setrusumab for the treatment of participants with OI.

Coordinator: Gregory Spires, BSN, RN, CRC

Contact: usfdiabetesresearchc@usf.edu | Phone Number: (813) 974-9536

Currently Enrolling Osteoporosis/Abnormal Bone Mineral Density Studies

Eligibility:
  • For women age 65+ and men age 70+
  • Diagnosis of osteoporosis or abnormal Bone Mineral Density OR History of fracture

Purpose: To create a comprehensive database of patients with abnormal bone mineral density (BMD)/fragility fractures and/or presence of risk factors, regardless of the etiology for clinical and research use, with the ability to analyze patterns, quality, and costs of care over time along with monitoring screening, treatment and outcomes.

Coordinator: Iryna Pestun, MD

Contact: bonehealthregistry@epi.usf.edu | Phone Number: (813) 974-9295

Study Flyer

TEDDY Study compares characteristics of children diagnosed with type 1 diabetes before and after age 6

New findings from the international The Environmental Determinants of Diabetes in the Young (TEDDY) study add to the growing body of evidence indicating that type 1 diabetes is not a single disease.

Click here to view full article.


USF Awarded Four-Year, $69.9 Million NIH Grant to Continue Type 1 Diabetes Research

The Environmental Determinants of Diabetes in the Young study is led by USF Health’s Jeffrey Krischer, who has built a worldwide epidemiological hub for T1D research at USF. 

Click here to view full article. 


Nature highlights USF Health-led TEDDY study as a diabetes research milestone

Click here to view article.


 

USF Health Informatics Institute contributes to new NIH study indicating that measuring gene expression changes over time may help predict type 1 diabetes progression in at-risk children, and lead to earlier diagnosis of the autoimmune disease.

Click here to read the full article.  


USF Diabetes Center Focuses on Pathway to Prevention

How Can I Help Find A Way to Prevent Type 1 Diabetes?