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Type 1 Diabetes Clinical Research

The Type 1 diabetes clinical research team at Indiana University School of Medicine is working to advance detection and treatment for people at all stages of diabetes development and progression.

The three main goals of the research team are to prevent disease development in people who are high risk, preserve beta cell function in newly diagnosed patients, and improve quality of life through technology and therapeutics in persons with established diabetes.

Clinical Research at IU School of Medicine

Learn more about the focus and phases of clinical research and explore additional active studies conducted by IU School of Medicine physician investigators.

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Diabetes Prevention

The Type 1 diabetes clinical research team screens first and second degree relatives of people with Type 1 diabetes to assess risk for disease. The purpose of screening is to identify opportunities for earlier disease intervention and possible prevention.

Preserving Beta Cell Function

Clinical trials to preserve beta cell function involve both adults and children with newly diagnosed Type 1 diabetes. Research in these studies aims to prolong the function and survival of the insulin-secreting beta cells by using different therapeutic agents.

Improve Quality of Life

Clinical trials to preserve beta cell function involve both adults and children with newly diagnosed Type 1 diabetes. Research in these studies aims to prolong the function and survival of the insulin-secretinType 1 diabetes is a serious chronic condition that must be constantly monitored by the patient or a caregiver. Clinical research at IU School of Medicine seeks to improve the quality of life for people with Type 1 diabetes and caregivers through the investigation of novel therapies, technology and delivery methods.g beta cells by using different therapeutic agents.

Active Studies

Currently, the clinical research team is conducting studies involving people who have a high risk for Type 1 diabetes, patients with newly diagnosed Type 1 diabetes and people with established Type 1 diabetes.

Questions or requests for additional information may be directed via email to a study coordinator.

Prevention and Early Intervention

  • Hydroxychloriquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At Risk for Type 1 Diabetes Mellitus

    Study Coordinator: Megan Legge, CCRP
    Open for enrollment: Yes

    A research study for people with two or more autoantibodies (identified through the TrialNet Pathway to Prevention) and normal glucose tolerance based on results from oral glucose tolerance testing (OGTT). We are testing whether Hydroxychloroquine will protect beta cells from the immune system attack that leads to type 1 diabetes.

  • TrialNet Pathway to Prevention

    Study coordinator: Eric Grubbs, BS
    Open for enrollment: Yes

    The purpose of this observational study is to detect Type 1 diabetes at its earliest stages. Family members of people with Type 1 diabetes are screened for autoantibodies associated with Type 1 diabetes development.

  • Hydroxychloriquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At Risk for Type 1 Diabetes Mellitus

    Study Coordinator: Megan Legge, CCRP
    Open for enrollment: Yes

    A research study for people with two or more autoantibodies (identified through the TrialNet Pathway to Prevention) and normal glucose tolerance based on results from oral glucose tolerance testing (OGTT). We are testing whether Hydroxychloroquine will protect beta cells from the immune system attack that leads to type 1 diabetes.

Patients with Newly Diagnosed Type 1

  • Identifying Serum and Urine Biomarkers of Type 1 Diabetes

    Study Coordinator: Marimar Hernandez-Perez, PhD

    Open for enrollment: Yes

    The purpose of this study is to develop and validate biomarkers that predict T1D disease risk and document disease progression based on blood and urine indicators of beta cell stress and death in persons with emerging and established T1D.

  • Protect: A Phase 3, Randomized, Double-Bling, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type 1 Diabetes

    Study Coordinator: Corinne Parks-Schenck, BSN, RN

    Open for Enrollment: Yes

    The purpose of this study is to determine the effects of Teplizumab on beta cell function in children recently diagnosed with Type 1 diabetes.

  • Prebiotic in Newly Diagnosed Type 1 Diabetes

    Study Coordinator: Marimar Hernandez-Perez, PhD

    The purpose of this study is to determine the effects of prebiotics on the gut microbiome and beta cell function in children recently diagnosed with type 1 diabetes.

  • Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer)

    Study Coordinator: Megan Legge, CCRP

    Open for Enrollment: Yes

    The purpose of this study is to determine the effects of hybrid closed loop insulin pump therapy and verapamil on beta cell function in children recently diagnosed with type 1 diabetes.

Patients with Established Type 1 Diabetes

  • Recruitment Database

    Study coordinator: Marimar Hernandez-Perez, PhD

    Open for enrollment: Yes

    With consent from participants the Type 1 Diabetes Research Team collects and securely stores information to determine eligibility for future research studies. If a person in the database appears to meet criteria for inclusion in a future study, they can be contacted by the research team to see if they would like additional information about participating.

  • Profiling Overweight Youth with Type 1 Diabetes

    Study Coordinator: Eric Grubbs, BS

    Open for Enrollment: Yes

    The purpose of this observational study is to profile the gut microbiome in youth with type 1 diabetes according to weight categories and then determine if differences in the gut microbiome profile are associated with differences in measures of β-cell stress and death.

  • A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog with an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents with T1D (PRONTO-Peds)

    Study Coordinator: Corinne Parks-Schenck, BSN, RN

    Open for enrollment: Yes

    The study medication for this research is a new investigational meal-time ultra rapid insulin called LY900014. The purpose of this study is to answer the questions:

    • Does LY900014 help to lower blood glucose levels in patients with type 1 diabetes?
    • How LY900014 controls blood glucose levels compared to Humalog?
  • Medtronic 304 - A Post-market Insulin Pump Study Testing Hybrid Closed Loop Features with an open label extension

    Study Coordinator: Eric Grubbs, BS

    Open for Enrollment: Yes

    The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL), built into the 670G insulin pump, in adult and pediatric patients with type 1 diabetes. Persons already using pumps and those taking insulin by injection can be enrolled.