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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-secreting beta cells by using different therapeutic agents. Type 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.

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

  • PETITE-T1D

    Study coordinator: Angelica McKibben, atmckibb@iu.edu
    Open for enrollment: Yes

    The purpose of this study is to evaluate the safety and tolerability of teplizumab treatment in participants with Stage 2 Type 1 diabetes who are less than 8 years of age. 

  • STOP-T1D
    Study coordinator: Angelica McKibben, atmckibb@iu.edu
    Open for enrollment: Yes
     
    The purpose of this study is to determine if low-dose anti-thymocyte globulin (ATG) medicine can delay or prevent Type 1 diabetes in people who have more than a 50% risk of diagnosis within the next 2 years.
  • TrialNet Pathway to Prevention (TN01)

    Study coordinator: Riley Pediatric Diabetes Research Team, pedsdiab@iupui.edu
    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.

  • Understanding Pancreatic Endocrine and Exocrine Loss in Pre-Type 1 Diabetes
    Study coordinator: Sophia Markoff, smarkoff@iu.edu
    Open for enrollment: Yes

    T1D is characterized by the autoimmune destruction of insulin-producing pancreatic β-cells. The purpose of this study is to examine the broad range of pancreas sizes in those with T1D risk to evaluate if a change from baseline over a defined time-period may provide the best sensitivity in estimating diabetes risk.

Patients with Newly Diagnosed Type 1

  • DESIGNATE

    Study coordinator: Hannah Lease, hlease@iu.edu
    Open for enrollment: Yes

    The purpose of this study is to identify a safe, metabolically favorable, dosing regimen for a medicine siplizumab in patients with Type 1 diabetes that induces changes in T cell phenotypes observed with Type 1 diabetes.

  • Identifying Serum and Urine Biomarkers of Type 1 Diabetes
    Study coordinator: Ellie Moreau, elmryan@iu.edu 
    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.

  • JAKPOT T1D
    Study coordinator: Ellie Moreau, elmryan@iu.edu
    Open for enrollment: Yes
     
    The purpose of this study is to evaluate the efficacy of a medicine (selective Janus kinase inhibitors) in preserving beta cell function in participants with recent onset Stage 3 Type 1 diabetes.
  • TADPOL

    Study coordinator: Ellie Moreau, elmryan@iu.edu
    Open for enrollment: Yes

    The purpose of this study is to investigate the potential of an oral medication difluoromethylornithine (DFMO) to alleviate stress on beta cells to preserve the body's intrinsic capacity to produce insulin following diagnosis.

  • T1D RELAY

    Study coordinator: Angelica McKibben, atmckibb@iu.edu
    Open for enrollment: Yes

    The purpose of this study is to evaluate the use of rituximab-pvvr and abatacept, one after the other, to learn if using both treatments extends insulin production in people newly diagnosed with Type 1 diabetes.

Patients with Established Type 1 Diabetes

  • Recruitment Database
    Study coordinator: Sarah Fischer, hollowas@iupui.edu
    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: Autumn Clark, autclark@iu.edu
    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. Eligibility requirements: Youth 11-18 years of age with T1D at time of enrollment