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Diabetes Research

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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:

Birth to 45 years of age and diagnosed with diabetes (type 1 or type 2)
45 years of age or less and have a first degree relative (siblings, offspring, and parents) with diabetes.
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, M.D. or the Study Coordinator; Linda Amstutz, R.N. or Cindy Elkins 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.

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.
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.
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, M.D. or the Study Coordinator; Stephanie Stein, R.N. 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:

Natural History Studies: to learn more about risk factors associated with the development of type 1 diabetes.
Diabetes Prevention Studies: to test therapies that may delay or prevent the onset of type 1 diabetes.
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, M.D. or the Study Coordinator; Linda Amstutz, R.N. at 1-866-230-8486 or (317) 278-8879

Nutritional Intervention to Prevent Diabetes (NIP) Study

This is a pilot study to plan a future larger study that looks at the role of Omega-3 fatty acid DHA (found abundantly in fish oils) in potentially preventing or delaying the onset of Type 1 diabetes in high-risk infants. The primary outcome for the larger study will be to determine if Omega-3 fatty acid given during the last trimester of pregnancy and/or the first three years of life for high-risk children will prevent the development of evidence of immune attack on the insulin-producing cells of the pancreas.

Subjects (entry point during pregnancy or entry as an infant prior to 6 months of age) will receive Omega-3 fatty acid supplements or placebo via capsules from the mother through the placenta or breast milk, as an infant through infant formula or capsules mixed in with food, or as a toddler in food. Comparisons will be made between the two groups.

Inclusion Criteria
Potential participants must meet the following inclusion criteria:

Pregnant mothers are eligible for enrollment into this study if they:

have T1D or the child's father, or a full or half-sibling of the child has T1D.
are 18 years of age or older.
are in their third trimester of pregnancy (24 weeks or longer).
have understood and signed a written informed consent and HIPAA medical information release.
are willing to be randomized to receive either the study supplement or a placebo (an inactive substitute).

Infants are eligible for enrollment into this study if they:

are less than or equal to six months (i.e. ¡Ü 182 days from the date of birth) of age on the date of randomization.
are found to be at risk for type 1 diabetes because they have a mother, father or full or half-sibling with T1D
AND
1. have a DR3 or DR4 allele (genetic markers of increased risk for type 1 diabetes) OR
2. have another 1st or 2nd degree relative with T1D.
3. have a parent or legal guardian who has understood and signed a written informed consent and HIPAA medical information release authorization.
have a parent(s) or legal guardian(s) who are willing for their baby to undergo randomization.

Exclusion Criteria
Potential participants must not meet any of the following exclusion criteria:

Pregnant mothers are NOT eligible for enrollment into this study if they:

have any condition the investigator believes will put the mother or her fetus at an unacceptable medical risk for participation in this study.
have a known complication of pregnancy causing an increased risk for the mother or fetus prior to entry into the study.
have previously had multiple (2 or more) pre-term births (<36 weeks).
are diabetic and have a known HbA1c greater than 9% at anytime during the pregnancy.

Infants are NOT eligible for enrollment into this study if they:

have any condition the investigator believes will put the subject at an unacceptable medical risk for participation in this study.
have a mother with a condition the investigator believes will put her at an unacceptable medical risk for participation in this study
have a nursing mother who plans to begin omega-3 fatty acid supplementation or a parent or legal guardian who plans to provide supplementation to his/her infant independently in the next 12 months
have a genetic marker known to decrease the risk for T1D.
were born prior to 36 weeks gestation or require a pre-term infant formula

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

Have a relative with T1D. 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.
Willing to sign the Informed Consent Form.
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
Insulin autoantibody confirmed positive within the previous six months.
Two samples with at least one autoantibody other than the insulin autoantibody within the previous six months.

Exclusion Criteria

Does not meet the above conditions. Subjects that are insulin autoantibody positive but have no other autoantibodies are not eligible.
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.
Prior participation in a trial for prevention of T1D.
History of treatment with insulin or other drug to lower blood sugar.
History of therapy with immunosuppressive drugs or steroids within the past two years for a period of more than three months.
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.
Pregnant or intends to become pregnant while in the study or breast feeding.
Unable to follow study instructions.
An abnormal glucose tolerance test.
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.

Anti-CD20 (Rituximab) New-onset Intervention Study

The goal of this study is to evaluate the safety, effectiveness, and to examine the action of rituximab, anti-CD20 monoclonal antibody, for the treatment of individuals with new onset type 1 diabetes. The main objective of this study is determine whether treatment with rituximab will allow people recently diagnosed with type 1 diabetes to make more insulin than untreated individuals 1-year after entering the study

The secondary goals of the study will examine the effect of the proposed treatment on markers of the immune system?s attack on the beta cells.

The study is a multi-center, two-arm, randomized, double-masked, placebo-controlled clinical trial. Both groups will receive standard intensive diabetes treatment with insulin and dietary management. This protocol will enroll a total of 66 participants who will be randomly assigned to the following two groups:

44 participants will receive active rituximab (anti-CD20 monoclonal antibody) as an intravenous infusion, with 4 administrations at weeks 0, 1, 2, and 3.
22 participants will receive placebo given as an intravenous infusion with 4 administrations at weeks 0, 1, 2, and 3.

The total length of the study will be 4 years (2 years recruitment and 2 years follow-up). Follow-up for up to 4 years will continue for those who have persistence of beta cell function at 2 years and/or detectable immune effects of treatment by descriptive analysis until the disappearance of detectable beta cell function or resolution of immune changes.

Inclusion Criteria
Potential participants must meet all of the following conditions:

Be between the ages of 8 and 45 years.*
Be within 3-months (100 days) of diagnosis of type 1 diabetes based on American Diabetes Association (ADA) criteria.
Must have at least one diabetes?related autoantibody present.
Must have evidence of significant insulin production.
If participant is female and of reproductive age, she must be willing to avoid pregnancy and have a negative pregnancy test.
At least one month from last immunization received.
Must be willing to work towards excellent blood sugar control with intensive diabetes management
Must weigh at least 25 kg at study entry.

*Enrollment will be limited to subjects 12-45 years until the TrialNet Data Safety Monitoring Board approves enrollment of younger children.

Exclusion Criteria
Potential participants must not meet any of the following exclusion criteria:

Are immunodeficient or have clinically significant long-term low white blood cell numbers.
Have an active infection or positive test result for tuberculosis.
Be currently pregnant or breast feeding, or anticipate getting pregnant.
Require long-term use of steroid medications.
Require use of other drugs that suppress the immune system.
Have blood test results that indicate current or past HIV, Hepatitis B, or Hepatitis C infection.
Have any complicating medical issues that interfere with the ability to participate in the study or cause increased risk including:
- pre-existing heart disease
- chronic lung disease or
- blood count abnormalities (such as low white blood cell or platelet counts).
Have a history of cancer.
Be currently using non-insulin drugs that affect blood sugars.
Be currently participating in another type 1 diabetes treatment study.

To learn more about TrialNet visit the website at: www.diabetestrialnet.org

For more information contact the Principal Investigator; Henry Rodriguez, M.D. or the Study Coordinators; Linda Amstutz, R.N., Lyla Christner, R.N., Cindy Elkins, R.N. or Susan Groover, R.N. at 1-866-230-8486 or (317) 278-8879

Type 1 Diabetes Genetic Consortium

The Consortium is a multi-center, international effort to identify and learn more about genes that may affect an individual's risk of developing type 1 diabetes (T1D). This is part of an effort to discover how differences in the genes that we inherit from our parents contribute to the risk of the development of Type 1 diabetes. We are looking for families in which there are at least two siblings (brothers and/or sisters) with Type 1 diabetes. In these families, the parents, the two siblings with diabetes and up to two without diabetes are eligible to participate. In the case of African-Americans or Latinos, families with only one affected individual are also eligible. A single clinic visit is required at which a blood sample will be drawn from each participating family member.

For more information contact the Principal Investigator; Henry Rodriguez, M.D. or the Study Coordinator; Linda Amstutz, R.N., Lyla Christner, R.N., Cindy Elkins, R.N. or Susan Groover, R.N. at 1-866-230-8486 or (317) 278-8879

[Keywords: research, type 1 diabetes, Continuous Subcutaneous Insulin Infusion Therapy, TrialNet]

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