UArizona Steele Children's Research Center researchers in the area pediatric endocrinology are focused on exploring ways to better understand type 1 diabetes in order to predict, prevent and better treat this chronic disease. We have a variety of clinical studies being conducted in Tucson and in Phoenix.
Clinical Studies—Research Consortia
Type 1 Diabetes TrialNet http://www.diabetestrialnet.org/
TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Europe, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes.
We are currently participating in two TrialNet Studies:
- TN01-Natural History Study of the Development of Type 1 Diabetes
The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes. The Natural History Study will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes. These results will also be used to identify people eligible to enroll in prevention studies, such as the oral insulin study (below).
- TN07- Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
This study is based on findings from the “Diabetes Prevention Trial of Type 1 Diabetes” study. Although the overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies, which are directed against insulin itself and were still making insulin in their pancreas. This Oral Insulin study will test the extent to which this intervention may prevent or delay type 1 diabetes.
Immune Tolerance Network http://www.immunetolerance.org/
The Immune Tolerance Network is an international clinical research consortium founded by the National Institutes of Health, whose mission is to accelerate the clinical development of immune tolerance therapies through a unique development model.
- T1DAL-Inducing Remission in Type 1 Diabetes With Alefacept
The purpose of this trial is to test whether an immunomodulating drug approved for psoriasis (alefacept) will slow or halt destruction of the beta cells in the pancreas. If the destruction of the beta cells is stopped the patients might be able to produce insulin on their own longer which could stop or slow the progression of their type 1 diabetes.
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes (Amylin Pharmaceuticals, Inc.)
Clinicaltrials.gov: NCT00658021. Site PI: Mark Wheeler.
Enrollment: ongoing. Type 2 Diabetes not taking insulin, ages 10-17.
The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) with exenatide is superior to that of placebo adolescent patients with type 2 diabetes.
A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (DIAPREVENT, Diamyd Therapeutics AB)
Clinicaltrials.gov: NCT00751842. Site PI: Mark Wheeler.
Enrollment: completed; follow-up is ongoing.
The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.
Clinical Studies--Investigator-initiated Studies
TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
Clinicaltrials.gov: NCT00684658. PI: Melissa Faulkner DSN, RN. Enrollment: closed. Type 1 Diabetes for > 6 months, ages 11-14.
The purpose of the study is to compare the effects of a 5-week internet-based coping skills training program (TeenCope) with a 5-week internet education program (Managing Diabetes) in youth (age 11-14) with type 1 diabetes on intensive insulin therapy.
Personalized Exercise for Adolescents With Diabetes
Clinicaltrials.gov: NCT00686283. PI: Melissa Faulkner DSN, RN. Enrollment: closed.
This study aims to determine the likely benefits of a study that would use the novel techniques both of writing an exercise "prescription" and of including the family and/or community in sticking to the exercise prescription by youths with diabetes, who often suffer eventual cardiovascular complications that might be lessened by the exercise.