Research/Clinical Trials

At the University of Iowa Children's Hospital we are involved in a variety of research focusing on the prevention, intervention and treatment of type 1 diabetes. Research opportunities exist for children and adolescents with type 1 diabetes as well as their family members. Below you will find a brief description of our current research projects.

DirecNet
Diabetes Research in Children Network (DirecNet) is a network of clinical centers dedicated to researching the potential use of glucose monitoring technology and its impact on the management of type 1 diabetes in children. The primary aim of DirecNet is to determine the optimal utilization of continuous glucose monitors in the management of T1DM in children, assess the impact of continuous glucose monitoring on quality of life for the child and family, to assess possible changes in neurocognitive function and how it relates to frequency of hypoglycemia in young children with type 1 diabetes, evaluate and develop distinct, age-appropriate treatment strategies to T1DM in children, use continuous glucose monitoring to characterize the glycemic profile of nondiabetic children, and develop statistical methods for the analysis of continuous glucose monitoring data.

Type 1 Diabetes TrialNet
Type 1 Diabetes TrialNet is a network of international diabetes research centers working together with sites throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Australia and New Zealand. This network is dedicated to the study, prevention and early treatment of type 1 diabetes. TrialNet is supported by the National Institutes of Health, Department of Health and Human Services, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, National Center for Research Resources, Juvenile Diabetes Research Foundation and the American Diabetes Association.

Type 1 Diabetes Genetics Consortium
The Type 1 Diabetes Genetics Consortium is a collaborative effort to develop resources for the purpose of identifying genes that increase (or decrease) an individual's risk for type 1 diabetes. The scientific objectives are to ascertain, study and establish a renewable source of DNA to create a database for the scientific community with clinical, genetic, and medical history information that would facilitate the search for type 1 diabetes susceptibility genes, to provide a centralized DNA repository to allow targeted studies of genetic structure and function for type 1 diabetes, and to evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy in the area of type 1 diabetes.

JDRF Artificial Pancreas Project The purpose of this research study is to evaluate Real Time-Continuous Glucose Monitoring (RT-CGM) devices. The RT - CGM is a device that has a small sensor that is inserted just underneath the skin which measures the blood sugar every 1 or 5 minutes and displays the results on a wireless receiver that is the size of a pager (beeper). The primary objective of the study is to determine if RT-CGM can improve glycemic control and quality

Exubera
The purpose of this research study is to test an experimental drug called Exubera® (inhaled insulin). Children, ages 6 -17 who have type 1 diabetes will be the focus of this study. While this drug is approved by the (Food and Drug Administration) FDA for use in adults, it is not yet approved for use in children. This study is being done to find out about the pulmonary (lung) safety of Exubera® (inhaled insulin) over a 12-month period in children and adolescents with type 1 diabetes mellitus. This study will also find out if the effect of Exubera® (inhaled insulin) on blood sugar control is comparable to subcutaneous insulin (SC) in children and adolescents with type 1 diabetes mellitus.

ENDOCRINOLOGY CLINICAL TRIALS

Our endocrine clinical trials are primarily industry-sponsored, multi-center studies that focus on an endocrine medication. Typical areas of interest include safety and efficacy of a medication, new indications for treatment, dosing regimens, and medication delivery devices. Trial subjects are recruited from our existing clinical population.

Our open clinical trials are as follows:

The effect of growth hormone treatment on children with classical or nonclassical growth hormone deficiency: National Cooperative Growth Study.

A four-year, open-label, multi-center randomized two-arm study of Genotropin™ in idiopathic short stature patients: Comparing an individualized, target-driven treatment regimen to standard dosing of Genotropin™.

GeNeSIS: The genetics and neuroendocrinology of short stature international study.

KIGS: Pfizer international growth study.

An open-label, non-comparative trial to evaluate the safety, efficacy and pharmacokinetics of Faslodex™ in girls with progressive precocious puberty associated with McCune-Albright Syndrome.

BASIC DIABETES RESEARCH

The laboratory of Andrew Norris, MD, PhD, is committed to the discovery of early molecular events that contribute to the pathophysiology and complications of diabetes. His laboratory has several active projects towards this end. (1) Characterization of the activity of muscle PPAR-gamma as a transcriptional switch to prevent the pre-diabetic state. (2) Studying of interventions to prevent the metabolic consequences of developmental exposure to excess glucose, fat, or insulin. (3) Use of bioinformatics to help discover novel master regulators of metabolic dysfunction and its rescue.