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Clinical Trials - Pediatric

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 6-17 
  • Diagnosed with Type 1 Diabetes in the last 100 days
  • Have at least 1 or more autoantibodies against Beta-Cell autoantigens

Purpose: To evaluate the safety and efficacy of immunotherapy with multiple peptides. 

Coordinator: Gregory Spires, BSN, RN, CRC

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

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 4-17
  • A1c >7.0 -<11.0%
  • Diagnosed with Type 1 Diabetes and using insulin for at least 6 months

Purpose: To demonstrate that the efficacy of Afrezza is noninferior to rapid-acting insulin analog (RAA) injections, when both are in combination with a basal insulin.

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

Dexcom

Eligibility:

  • CGM naïve
  • T1D or T2D insulin requiring
  • Age 2-17
  • Target recruitment 20

Purpose: This study is evaluating the safety of non-adjunctive CGM use in CGM-naïve participants, by assessing the number of hypoglycemic (Hypo) and diabetic ketoacidosis (DKA) events with use of CGM.

Coordinators: Janet Rodriguez, BSN, RN, CDCES, CRA-USF/ADVANCED; Henry Rodriguez, MD

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 T2D Studies

Dexcom

Eligibility:

  • Age 2-17
  • T1D or T2D req insulin for ≥ 3 months
  • CGM naïve > 1 year (can have trial)
  • Compatible smart phone or internet/computer to upload
  • Recruitment target 20

Purpose: This study is evaluating the safety of non-adjunctive CGM use in CGM-naïve participants, by assessing the number of hypoglycemic (Hypo) and diabetic ketoacidosis (DKA) events with use of CGM

Coordinators: Janet Rodriguez, BSN, RN, CDCES, CRA-USF/ADVANCED; Henry Rodriguez, MD

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

Eligibility:

  • For individuals ages 10-17        
  • Diagnosed with Type 2 Diabetes
  • A1c ≥ 6.5 - ≤ 9.0% 
  • Not tolerating Metformin
  • Using insulin for less than 8 weeks
  • BMI ≥ 85th percentile (WHO references)

Purpose: To learn whether empagliflozin and linagliptin may help control blood sugar levels in children and adolescents with T2D as Monotherapy. Empagliflozin and Linagliptin are oral drugs that are approved to treat T2D in adults, however, neither is approved to treat T2D in children & adolescents.

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

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

Eligibility:

  • For individuals ages 10 to < 18
  • Diagnosed with Type 2 Diabetes
  • A1c 6.5 – 11.0%
  • Treatment with ≥ 1000 mg/day of metformin for > 56 days OR ≥ 30 day stable basal (and metformin) OR ≥ 30 day stable basal 

Purpose: To confirm superiority of oral Semaglutide at the maximum tolerated dose* (3 mg, 7 mg or 14 mg) versus placebo on glycemic control in children and adolescents (age 10 to <18 years) with type 2 diabetes on a background treatment of metformin or basal insulin or both.

Coordinator: Juanita O'Brian, NRCMA

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

Eligibility:

  • For individuals ages 4-17
  • A1c >7.0 -<11.0%
  • Diagnosed with Type 2 Diabetes and using insulin for at least 6 months

Purpose: To demonstrate that the efficacy of Afrezza is noninferior to rapid-acting insulin analog (RAA) injections, when both are in combination with a basal insulin.

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

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?