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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

  • Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At Risk for Type 1 Diabetes (TN22)
    Study Coordinator: Megan Kirchner, 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 (TN01)

    Study coordinator: Sophia Markoff
    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
    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

  • Identifying Serum and Urine Biomarkers of Type 1 Diabetes
    Study Coordinator:  Corinne Parks-Schenck, BSN, RN

    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.

  • Prebiotic in Newly Diagnosed Type 1 Diabetes

    Study Coordinator: Katelyn Hagen
    Open for enrollment: Yes 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.

    Children eligible for this study must:

    • Be between 12-<17 years old •
    • Have been diagnosed with T1D within the past 4-24 months
  • Dompe - Ladarixin
    Study Coordinator: Corinne Parks-Schenck, BSN, RN
    Open for enrollment: Yes

    This research is studying an investigational drug called Ladarixin to see if it is effective in preserving β-cell function and delaying the progression of T1D in adolescent and adult patients ages 14-45.
    Eligibility requirements:

    • New onset Type 1 Diabetes (must receive 1st dose within 180 days of start of insulin therapy)
    • Positive for at least one diabetes antibody
    • Currently using insulin via injections or pump therapy
    • Fasting C-Peptide < 0.205 nmol/L

     

  • INHALE

    Study Coordinator: Dana Chatila
    Open for enrollment: Yes

    The purpose of this study is to find out whether an inhaled, ultra rapid-acting insulin works as rapid-acting injections.

    Children eligible for this study must:

    • Have type 1 or type 2 diabetes
    • Be at least 4 years old and less than 18 years at the start of the study
    • Use daily insulin injections
    • HbA1c levels between 7% and 11%
  • T1D and Bone Health
    Study Coordinator: Ellie Ryan
    Open for enrollment: Yes

    A research study studying the effect Type 1 Diabetes has on bone health and the gut microbiome. To be eligible, you must be age 12-20, have a HBA1c greater than 6.5% and have been diagnosed with T1D for at least 2 years.

  • RescuiNGkids Nasal Glucagon
    Study Coordinator: Dana Chatila
    Open for enrollment: Yes

    This research study is evaluating an investigational drug called nasal glucagon to see if it can safely increase blood sugar levels in children with Type 1 Diabetes (T1D) aged 1 to less than 4 years.

    Eligibility requirements are:

    • At least 1 year old and will not turn 4 before the end of the study
    • Were diagnosed with Type 1 Diabetes at least 6 months ago
    • Have been receiving insulin therapy via a pump or daily injections, and have been stable on therapy for at least 3 months before the start of the study
    • Are in otherwise good general health with no structural abnormalities in the nose or nasal cavity
    • Are able to give blood for the laboratory testing Have NOT had severe hypoglycemia (very low blood sugar) that required immediate administration of carbohydrate or glucagon in the 3 months before the start of the study
    • Do NOT have any presence or history of hypersensitivity to glucagon or related products or severe hypersensitivity to any other medication

Patients with Established Type 1 Diabetes

  • Recruitment Database
    Study coordinator: Sarah Holloway
    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: Katelyn Hagen

    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
  • RescuiNGkids Nasal Glucagon
    Study Coordinator: Dana Chatila
    Open for enrollment: Yes

    This research study is evaluating an investigational drug called nasal glucagon to see if it can safely increase blood sugar levels in children with Type 1 Diabetes (T1D) aged 1 to less than 4 years.

    Eligibility requirements are:

    • At least 1 year old and will not turn 4 before the end of the study
    • Were diagnosed with Type 1 Diabetes at least 6 months ago
    • Have been receiving insulin therapy via a pump or daily injections, and have been stable on therapy for at least 3 months before the start of the study
    • Are in otherwise good general health with no structural abnormalities in the nose or nasal cavity
    • Are able to give blood for the laboratory testing Have NOT had severe hypoglycemia (very low blood sugar) that required immediate administration of carbohydrate or glucagon in the 3 months before the start of the study
    • Do NOT have any presence or history of hypersensitivity to glucagon or related products or severe hypersensitivity to any other medication
  • TOPPLE

    Study Coordinator: Corinne Parks-Schenck, BSN, RN
    Open for enrollment: Yes

    The purpose of this Phase 1 study is to test the safety of a new treatment intended to slow down or stop diabetes in people at high risk before clinical diagnosis. The treatment is a plasmid vector designed to transfer DNA into cells where it can communicate with the immune system. Earlier lab studies show this treatment might retrain the immune system to stop its attack on the insulin-producing beta cells.

    Eligibility requirements: Ages 18-45 and a T1D diagnosis in the past 48 months

  • INHALE

    Study Coordinator: Dana Chatila
    Open for enrollment: Yes

    The purpose of this study is to find out whether an inhaled, ultra rapid-acting insulin works as rapid-acting injections.

    Children eligible for this study must:

    • Have type 1 or type 2 diabetes
    • Be at least 4 years old and less than 18 years at the start of the study
    • Use daily insulin injections
    • HbA1c levels between 7% and 11%