Research/Clinical Trials

DIABETES CLINICAL TRIALS

The University of Iowa Children's Hospital is involved in a variety of research focusing on the prevention, intervention, and treatment of diabetes.   Opportunities exist for patients with diabetes as well as their family members. Below you will find a brief description of our current research projects.

Current studies open to enrollment:

DirecNet
Diabetes Research in Children Network (DirecNet) is a network of 5 clinical centers across the country dedicated to researching the use of glucose monitoring technology and its impact on the management of type 1 diabetes (T1D) in children. http://direcnet.jaeb.org

• Cognitive and Neuroanatomical Consequences of Type 1 Diabetes in Young Children.  The purpose of this research study is to find out how diabetes impacts development of the brain, memory and thinking in young children who are at least 4 years but not yet 8 years of age. 

TrialNet
TrialNet is an international network of diabetes research centers dedicated to the study, prevention, and early treatment of type 1 diabetes.http://www.diabetestrialnet.org/index.htm

• Natural History Study of the Development of Type 1 Diabetes
  Relatives of people with type 1 diabetes have a 10 to 15 times greater risk for developing the disease than people with no family history. This study screens and observes relatives to learn more about how the disease occurs.

• Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus.  This study tests whether a daily oral insulin capsule can prevent or delay the disease in at-risk relatives of people with type 1 diabetes.

• Anti-CD3 mAb (Teplizumab) for Prevention Of Diabetes In Relatives At Risk For Type 1 Diabetes Mellitus.  This study tests whether teplizumab helps stop or slow down the autoimmune process that is destroying beta cells in people who are at high risk of developing type 1 diabetes.

Immune Tolerance Network

• RETAIN STUDY:  Effect of Intravenous Alpha-1 Antitrypsin on Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus (ITN041AI).  Evaluating the ability of the medication ARALAST NP to halt the progression of type 1 diabetes. ARALAST NP is an anti-inflammatory drug that may also affect immune cells that are involved in the development of type 1 diabetes. Past studies have shown that it can reverse new-onset diabetes in non-obese diabetic mice and inhibit the rejection of transplanted islet cells in animal models of diabetes.  http://www.retainstudy.org

• T1DAL STUDY: Inducing Remission in New Onset T1DM With Alefacept (Amevive).  Evaluating the ability of a drug called alefacept (also called Amevive®) to halt the progression of type 1 diabetes.  By suppressing the immune system in patients recently diagnosed, this study is designed to test whether alefacept will slow or halt destruction of the beta cells in the pancreas. If the destruction 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.  Alefacept is FDA-approved for use by adults for other purposes.   http://www.t1dal.org

Current Studies closed to enrollment:

Macrogenics

• Protégé Study:  A Phase 2/3, Randomized, Double Blind, Multicenter, Multinational, 4 Arm, Controlled, Dose Ranging Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non Binding, Anti CD3 Monoclonal Antibody, in Children and Adults with Recent Onset Type 1 Diabetes Mellitus.   

• Encore Study:  A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus.

DiaPrevent

• A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus

TrialNet

• Nutrition Intervention to Prevent (NIP) Type 1 Diabetes Pilot Trial
  A pilot study testing whether docosahexaenoic acid (DHA), and omega-3 fatty acid found in some foods can prevent or delay the autoimmunity leading to type 1 diabetes.  

DirecNet

• Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to 10 Year Olds).
  Determine the efficacy, tolerability, safety, and effect on quality of life of the continuous glucose monitors in young children with type 1 diabetes.

• Pilot Study to Assess the Feasibility of Real-time Continuous Glucose Monitoring in the Management of Infants and Toddlers with Type 1 Diabetes
  Determine if it is possible to use continuous glucose monitors (CGM) in children with type 1 diabetes who are less than 4 years old and how parents feel about their child’s using a CGM.

• Relationship Between Loss of beta-cell Function and Loss of alpha-cell Response to Hypoglycemia Early in Type 1 Diabetes
  Determine the relationship of cells in the pancreas that produce insulin and cells that produce glucagon in children between the ages of 8 and 18 to help doctors control type 1 diabetes better with fewer low blood sugar problems.

For more information call our toll-free number 1-866-309-0837
or
email: pediatric-diabetes-research@uiowa.edu