Department of Pediatrics

Pediatric Diabetes and Endocrinology Clinical Studies

Master
Content

RADIANT (Rare and Atypical Diabetes Network) (H-46235)
The purpose of RADIANT study is to discovery and classify new and unusual forms of diabetes.

TODAY and TODAY2 - Type 2 Diabetes (H-14285, H-23282, H-26921, H-33641)
The aim of this study is to understand the best treatment options for youth with type 2 diabetes and the complications related to early onset type 2 diabetes.

TrialNet Affiliate Site: Pathway to Prevention (H-27050)
The aim of this study is to identify individuals at risk for type 1 diabetes, seeking relatives of individuals with type 1 diabetes.

TrialNet Affiliate Site: Prevention and New Onset Trials (H-36243)
The aim of this study is to conduct clinical trials for prevention of type 1 diabetes and in patients with new-onset type 1 diabetes to preserve beta-cell function.

SWPDC FDA Real World Evidence Study for Type 1 Diabetes (H-46474)
The aim of this study is to develop a standalone software system and application that will provide contextual and clinically relevant data dashboards synthesized from multiple devices to enable improved patient encounters and clinical management of acute glycemic events and impact long term clinical outcomes for youth with T1D. 

Type 1 Diabetes Genetic Risk Scores (GRS) in TrialNet (H-45218)
The aim of this study is to test the type 1 diabetes genetic risk scores for predication of type 1 diabetes and selection of candidates for prevention trials.

Race/ethnicity-specific Type 1 Diabetes Genetic Risk Score in Pediatric Diabetes (H-48980)
The aim of this study is to test type 1 diabetes genetic risk scores in combination with other characteristics present at diabetes diagnosis to accurately and timely classify diabetes type in racially/ethnically diverse youth. 

Omnipod Horizon Preschool Cohort (H-48024)
This study is a single-arm, multi-center, prospective clinical study to evaluate the safety and effectiveness of the Omnipod Horizon Automated Glucose Control System in preschool children (2-5.9 years) with type 1 diabetes.

Omnipod Horizon Pivotal Study (H-46880)
This study is a single-arm, multi-center, prospective clinical study to evaluate the effectiveness of the Omnipod Horizon Automated Glucose Control System in children aged 6-13.9 years and adults aged 14-70 years.

Enhancement of Biomarkers for Type 1 Diabetes (H-41091)
The aim of this study is to utilize immunologic biomarkers, in particular a variant-specific IA-2 autoantibodies, for type 1 diabetes prediction.

Bone Health and Metabolism in Youth (H-45986)
Adolescents and young adults (ages 12-18 years; normal weight and overweight) with and without type 2 diabetes are needed for a research study to investigate the effect of obesity and childhood onset diabetes on bone health and risk of heart disease in youth.

AB Classification Study in Pediatric Diabetes (H-45745)
This is a study to test the usefulness of new classification system in pediatric diabetes using islet autoimmunity and insulin production capacity.  And to identify biomolecular differences by fasting plasma metabolomics between type 1 diabetes and type 2 diabetes compared to healthy controls. 

A Phase 3 Randomized Controlled Trial of Ladarixin in New-Onset Type 1 Diabetes (H-49339)
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladaraxin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline.

DiaBetter Together - Type 1 Diabetes (H-45360)
This randomized control trial is testing a strengths-based peer support program for young adults with type 1 diabetes who are transitioning from pediatric to adult diabetes healthcare. 

PRISM- Promoting Resilience in Stress Management Intervention (H-45623)
This randomized control trial is testing a resilience-building skills program for adolescents with T1D and elevated diabetes distress 

Addressing Social Needs and Behavioral Health Early in the Type 1 Diabetes Course to Mitigate Inequitable Health Outcomes among Socioeconomically Disadvantaged Minority Youth (H-49311)
The aim of this study is to mitigate health disparities by addressing social needs and behavioral health early in the course of type 1 diabetes. 

Setmelanotide Phase 2 Treatment Trial in Patients With Rare Genetic Disorders of Obesity (H-43952)
This is a study to determine the effect of setmelanotide (RM-493) on weight, hunger assessments and other factors in patients with rare genetic disorders of obesity.

Phase 3 intranasal carbetocin in Prader-Willi syndrome (H-45038)
This Phase 3 study is designed to test the effectiveness and tolerability of intranasal carbetocin (LV-101),an oxytocin analog, in participants with Prader-Willi syndrome (PWS).