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The faculty and staff at Riley Hospital for Children are engaged in a number of research projects which will lead to improved health for children with diabetes and their families.

Type 1 Diabetes

What is type 1 diabetes?

Type 1 diabetes (T1D) is a life-long disease that typically occurs in children but can present in adults. It occurs when the body attacks and destroys the insulin-producing cells in the pancreas. Destruction of the cells is gradual and most symptoms of diabetes do not begin until the majority of the insulin-producing cells are destroyed. Most people do not realize they are developing diabetes until there has been extensive loss of the insulin producing cells.

Current Studies

Diabetes Recruitment Registry

The registry is a list of people interested in receiving information about diabetes research at Riley Hospital. Participating individuals will complete a health history form that will be kept on file. This will allow members of the Riley Diabetes Research team to contact interested participants about current or future diabetes research studies. In order to participate in the registry, you must have diabetes or have a relative diagnosed with diabetes that meets the following criteria:

1. Birth to 45 years of age and diagnosed with diabetes (type 1 or type 2)
2. 45 years of age or less and have a first degree relative (siblings, offspring, and parents) with diabetes.
3. 20 years of age or less and have a second degree relative (nieces, nephews, aunts, uncles, grandparents, cousins, half-siblings) diagnosed with diabetes.

For more information contact the Principal Investigator; Henry Rodriguez, MD or Martha Mendez at 1-866-230-8486 or 317-278-8879.

Long Term Insulin Pump Therapy in Very Young Children with Diabetes

This JDRF-funded study is designed to evaluate comprehensively a series of outcomes related to insulin pump therapy in children with type 1 diabetes. We are using a multi-pronged, multi-layered approach incorporating cross-sectional, retrospective, and prospective studies to delineate the effects of pumps on blood sugar, brain function, and psychosocial aspects of diabetes management. Specifically, we are engaged in the following 3 studies.

1. Investigations of clinical, brain function, behavioral, academic achievement, and quality of life measures in 20 children aged 6-10 years diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3 years) compared to children matched for age, sex, average blood sugars, and diabetes duration treated with insulin injections.
2. Assessments of blood sugar outcomes, cognitive outcomes, parenting stress, and diet changes in 40 children with diabetes under 5 years of age prior to and 12 months after the implementation of insulin pump therapy.
3. Analysis of our clinic population utilizing pumps, collecting outcomes data on: clinical variables, predictors of long-term 'success' in blood sugar control, quality of life, and autonomy in diabetes management.

For more information contact the Principal Investigator; Linda DiMeglio, MD or the Study Coordinator; Stephanie Stein, RN at 317-274-3889

Type 1 Diabetes TrialNet

Type 1 Diabetes TrialNet is an international network of clinical centers dedicated to conducting research to prevent type 1 diabetes in those at risk for the disease and also to discover therapies that will preserve the body's capacity to produce insulin in those that are recently diagnosed with the disease. TrialNet researchers are experts in both diabetes and the body's immune system.

TrialNet will be conducting three types of research:

1. Natural History Studies: to learn more about risk factors associated with the development of type 1 diabetes.
   
2. Diabetes Prevention Studies: to test therapies that may delay or prevent the onset of type 1 diabetes.
   
3. Diabetes Intervention Studies: to test therapies that may preserve insulin secretion in people recently diagnosed with type 1 diabetes.

Natural History Studies: Our goal is to further knowledge about risk factors in individuals at risk for developing Type 1 Diabetes. We are studying close relatives of people with Type 1 Diabetes in three phases: Phase I: Screening, Phase II: Baseline Risk Assessment, and Phase III: Follow-Up Risk Assessment. Relatives of people with Type 1 Diabetes have a 10 to 15 times greater risk for the disease than people with no family history. Therefore, TrialNet is screening first and second-degree relatives of people with this type of diabetes. The screening test is done first to see if specific autoantibodies are present in the blood. These autoantibodies include ICA, GAD65, IAA and ICA512, and are a sign that the immune system may be attacking the insulin-producing cells in the pancreas. Autoantibodies are proteins made by the immune system which indicate a greater risk for developing Type 1 Diabetes. About 4 percent of family members of people with Type 1 Diabetes have autoantibodies. To do the test, a small sample of blood is drawn from the arm. To participate in the Screening Phase, individuals must be:

• 45 years of age or younger and have a brother, sister, child, or parent with Type 1 diabetes, or
• 20 years of age or younger and have a cousin, aunt, uncle, niece, nephew, half sibling, or grandparent with Type 1 diabetes.

Children less than 1 year old are not eligible to be screened.

Note: Someone probably has Type 1 Diabetes if he/she:

• Developed diabetes before age 40 years of age AND
• Started taking insulin injections within a year of diagnosis

Individuals that are found to be autoantibody-positive will be offered the opportunity to have additional tests that will allow more precise estimation of their chances of developing type 1 diabetes.

In addition to having the opportunity to be enrolled in the surveillance component of the Natural History Study, qualifying individuals may be eligible for enrollment in Prevention Studies.

All research volunteers will be closely monitored for early detection of type 1 diabetes. Early detection of type 1 diabetes may improve blood sugar control and reduce the chances of developing complications. In addition, study participation may help other people at risk for type 1 diabetes.

Diabetes Prevention Studies: These studies are designed to determine whether new therapies can delay, or prevent, the onset of type 1 diabetes in 'at risk' individuals. The development of diabetes maybe delayed, or prevented in those participating, if the therapy being tested is successful (Note: Eligibility criteria will vary for different diabetes prevention studies)

For more information contact the Principal Investigator; Henry Rodriguez, MD or Martha Mendez at 1-866-230-8486 or 317-278-8879

Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Study

The purpose of the TrialNet Oral Insulin Trial is to determine whether repeated treatment with oral (by mouth) human insulin, will prevent or delay the development of Type 1 Diabetes (T1D) in non-diabetic relatives of patients with T1D who are positive for insulin autoantibodies but who do not have a elevated blood sugars.

Subjects will be randomized to receive oral insulin or a placebo (inactive substance). The primary outcome is development of T1DM.

Recruitment and initial screening to identify subjects will be done through the TrialNet Natural History Study of the Development of Type 1 Diabetes study. As part of this study, subjects will have additional testing, and if eligible and willing, will be entered into the Oral Insulin trail.

Eligible subjects are non-diabetic relatives of patients with T1DM, who have normal blood sugars in response to an oral glucose tolerance test (OGTT), who are confirmed to be positive for antibodies to insulin and as well as other diabetes autoantibodies.

The primary outcome of this study is the time from study entry to the development of diabetes as defined by the American Diabetes Association (ADA).

Secondary objectives include the description of the effects of treatment with oral insulin compared to placebo in other indicators of diabetes risk. Secondary objectives also include the assessment of the effects of treatment on the immune system and blood sugar control, and the association of these markers with the risk of diabetes risk factors.

Inclusion Criteria

1. Have a relative with T1D.
2. If the relative is a sibling or a child, the study participant must be 3-45 years of age. If the relative is a second or third degree relative (i.e. Niece, Nephew, Aunt, Uncle, Grandchild, Cousin), the study participant must be 3-20 years of age.
3. Willing to sign the Informed Consent Form.
4. An oral glucose tolerance test performed within 7 weeks prior to randomization in which:
• fasting plasma glucose < 110 mg/dL, and
• 2 hour plasma glucose < 140 mg/dL
5. Insulin autoantibody confirmed positive within the previous six months.
6. Two samples with at least one autoantibody other than the insulin autoantibody within the previous six months.

Exclusion Criteria

1. Does not meet the above conditions. Subjects that are insulin autoantibody positive but have no other autoantibodies are not eligible.
2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary, renal, hepatic, immune deficiency and/or disease that is likely to limit life expectancy or lead to therapies such as immunosuppression during the time of the study.
3. Prior participation in a trial for prevention of T1D.
4. History of treatment with insulin or other drug to lower blood sugar.
5. History of therapy with immunosuppressive drugs or steroids within the past two years for a period of more than three months.
6. Ongoing use of medications known to affect blood sugar such as. sulfonylureas, growth hormone, metformin, anti-seizure drugs, diuretics, certain drugs used to treat high blood pressure, niacin. Subjects on such medications should be changed to a suitable alternative, if available, and will become eligible one month after medication is discontinued.
7. Pregnant or intends to become pregnant while in the study or breast feeding.
8. Unable to follow study instructions.
9. An abnormal glucose tolerance test.
10. Subject has genetic markers associated with a lowered risk for type 1 diabetes.

Intervention Studies in Newly-Diagnosed Diabetes

It is thought that 10-15% of the normal number of insulin-producing beta cells remain in the pancreas at the time that someone is diagnosed with diabetes. The ability to produce insulin, even quantities that are not able to bring blood sugars into the normal range, has been shown to decrease serious low blood sugars (hypoglycemic events) and the long-term complications of diabetes.

• The goal of these research studies is to preserve insulin secretion in people newly diagnosed with type 1 diabetes
• Eligible participants will be randomly (like the flip of a coin) put in either an experimental treatment group or a control group. The experimental group will receive the new treatment while the control group will receive a "pretend" treatment. This how researchers know if the experimental treatment is successful.

GAD in New Onset Type 1 Diabetes

Status: Recruiting

Eligibility Criteria

To join this study, you must fulfill both conditions below:

• Between 3 and 45 years old
• Diagnosed with type 1 diabetes less than 3 months ago (within the past 100 days)

About this Study

Type 1 diabetes is an autoimmune disease. This means that your immune system, the part of the body that helps fight infections, mistakenly attacked the cells in your body that produced insulin. These cells, called beta cells, are found in your pancreas.

This attack probably started years ago. Once many of your beta cells were damaged, your blood glucose levels went too high, and you had to start taking insulin by injection.

At this point, when you have had diabetes for less than three months, you may have beta cells left that produce some insulin. People who continue to make a little insulin may have fewer problems with low blood glucose (hypoglycemia). They may also have an easier time keeping their blood glucose levels in the normal range. This lowers the risk of the long-term complications of diabetes.

Right now, there is no proven treatment that will protect the remaining beta cells. In type 1 diabetes, the body's immune system keeps destroying them. By a few years after diagnosis, most people with type 1 diabetes are making no insulin of their own.

In this study, we are testing whether a protein called glutamic acid decarboxylase (GAD) will help people continue making some of their own insulin. This research study will compare people who get GAD injections with those who get placebo injections (shots that look the same but have no GAD).

What will I be asked to do?

Two-thirds of the people in this study will get injections of the GAD protein. They are in the treatment group.

One third of the people in this study will get injections that look like GAD but have no active drug. This is called a placebo injection. The people getting the placebo injections are in the control group.

Both groups will have 13 study visits over 2 years. At 3 of these visits, participants will get injections of either the GAD protein or placebo. You can't choose your group. A computer will choose your group for you. It's by chance, like drawing straws. This is called random assignment, or randomization.

This study is double-masked. While the study is going on, neither you nor your study team will know if you're in the treatment group or the control group. At the end of the study, we will tell you whether you were in the treatment group or the control group.

As a research volunteer, you can decide to stop being in this study at any time. We hope that you will stay in the study. You will be helping us learn more about how to help people with diabetes.

For more information contact the Principal Investigator; Henry Rodriguez, MD or the Study Coordinator; Martha Mendez, 1-866-230-8486.