BDC: Clinical Research

Clinical Research

The Barbara Davis Center for Childhood Diabetes, located at the University of Colorado Denver, is actively involved in clinical research. The research division has several on-going studies, as well as ones that are open for enrollment. These studies are all dedicated to the pursuit of preventing diabetes in high risk patients as well as clinical intervention with those already diagnosed with Type 1 diabetes.

The following studies are currently enrolling eligible participants. Please click on the study title for more specific information about the study and eligibility requirements.

*Study Title*	*Looking for...*
DEFEND-I: Phase 3 Trial of Otelixizumnab for Young Adults With Newly Diagnosed Type I Diabetes Mellitus	18-35 years of age; have been diagnosed with type 1 diabetes within 90 days of the time you receive the study drug or placebo; have required insulin treatment since being diagnosed; have evidence of residual beta-cell function (a test will be done to determine this); have a positive test result for one or more of the autoantibodies typically associated with autoimmune diabetes (a test will be done to determine this)
Phase II trial of hOKT3g1(Ala-Ala), Teplizumab, for treatment of patients with recent onset Type 1 diabetes mellitus (Delay Study)	People recently diagnosed with Type 1 Diabetes within the past 4 - 12 months. 8 years old - 30 years old
Primary Intervention with Mucosal Insulin for Prevention of Type 1 Diabetes: Pre-POINT	Children who do not have diabetes; ages 2 to 7 years old. Have at least one brother or sister or both parents with type 1 diabetes.
Effects of GAD on the Progression of Type 1 Diabetes in New Onset Subjects (The GAD65 Research Study)	People who have been diagnosed with Type 1 Diabetes within the past 3 months. Age 3-45 years old. Presence of GAD65 antibody
TrialNet: Natural History Study of the Development of Type 1 Diabetes	Relatives of people with type 1 diabetes: 1st degree blood relatives ages 1-45 and 2nd degree relatives ages 1-20.
TEDDY (The Environmental Determinants of Diabetes in the Young) View TEDDY STUDY DVD here.	Newborns with no family history of Type 1 diabetes. Young siblings and offspring of persons with type 1 diabetes.
TrialNet: Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes	Previously screened in the Natural History Trial, and identified high-risk for the development of Type 1 diabetes.
AbATE Type 1 Diabetes Trial for New Onset Diabetes	Type 1 diabetes diagnosis within last 6 weeks. Ages 8-30.
Effect of Antithymocyte Globulin (ATG) on Preserving Beta-Cell Function in New Onset Type 1 Diabetes Mellitus	Type 1 diabetes diagnosis within the last 6 weeks. 18-35 years old.
TrialNet: Effect of CTLA-4 Ig (Abatacept) on the Progression of Type 1 Diabetes in New Onset Subjects	Type 1 diabetes diagnosis within the past 3 months. 6 - 45 years old.
Phase I Study of BHT-3021 in Subjects with Type 1 Diabetes	Type 1 diabetes diagnosis. Ages 18 years and above, detectable C-peptide levels.
Randomized Study of Real-Time Continuous Glucose Monitors in the Management of Type 1 Diabetes	Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year. Age >8 years. HbA1c less than or equal to 10.0%
TolerX Type 1 Diabetes Trial	Type 1 diabetes diagnosis, ages 18-60, detectable C-peptide.
Twin Family Study of Islet Cell Autoimmunity	Identical and fraternal twins and triplets who are affected with type 1 diabetes and their unaffected co-twins, non-twin siblings, and parents. Type 1 diabetes in the affected twin defined as onset < age 40 and use of daily insulin therapy within one year of diagnosis. Affected twin with onset ≥ age 40 may be included if documented by the presence of islet cell autoantibodies. Twins who are concordant for type 1 diabetes may be included in the study if one twin was tested for autoantibodies prior to the development of diabetes, as may be the case for subjects in DPT-1 or TrialNet.
Determinants of Macrovascular Disease Risk in Adolescents With Type 1 Diabetes	Type 1 diabetes diagnosis for at least 5 years. Ages 12-19 AND controls - adolescents without any diabetes ages 12-19.
Vytorin And Simvastatin Trial (VAST)	Children with type 1 diabetes between the ages of 12-18 years with elevated cholesterol and no other serious medical problems.

Current information on various JDRF-funded clinical trials.