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Clinical Research Studies

Prevention and Intervention Trials for Patients

The Barbara Davis Center for Diabetes, located at the University of Colorado Anschutz Medical Campus, is actively involved in clinical research. The research division has several on-going studies, as well as ones that are ope​n for enrollment. These studies are all dedicated to the screening and understanding of type 1 diabetes, the pursuit of preventing diabetes in high-risk patients as well as clinical intervention for those already diagnosed with type 1 diabetes.

The studies listed below are currently enrolling eligible participants. The BDC is a nationally recognized diabetes research center.

​Clinical Research Studies

​COMIRB #: 12-1578

CLTA-4 (Abatacept) for Prevention of Abnormal Glucose Tolerance in relatives at risk for Type 1 Diabetes Mellitus

Inclusion criteria:

  • Be a participant in the TrialNet Pathway to Prevention study
  • Age 6 years and older
  • Positive for 2 or more diabetes related autoantibodies
  • Normal oral glucose tolerance tests (OGTTs)

Procedures involved:

  •  Willing to give informed consent/assent
  •  Willing to participate in follow-up visits every 3-6 months
  •  Willing to receive 14 infusions over a 12 month period

Compensation:

  •  Provided

Principal investigator: Peter Gottlieb, MD

Study coordinator: Ruthie Williamson, RN, 303-724-6894

​COMIRB #: 03-394

Natural History Study of the Development of Type 1 Diabetes - Screening

Inclusion criteria:

  • ​Ages 1-45 years with a first degree relative with type 1 diabetes
  • Ages 1-20 years with a second degree relative with type 1 diabetes
  • Children can be re-screened yearly until age 18; those who test positive may continue to the monitoring phase – annual blood draws or semi-annual oral glucose tolerance tests (OGTTs), depending on risk

Procedures involved:

  • Willing to give informed consent/assent
  • Blood draw – up to 1 tablespoon of blood at each visit

Compensation:

  • Provided in the monitoring phase

Principal investigator: Andrea Steck, MD

Study coordinator: Betsy Burke, RN, 303-724-6766

COMIRB #: 103-394

Natural History Study of the Development of Type 1 Diabetes - Monitoring

Inclusion criteria:

  • Identified as having positive diabetes autoantibodies through TrialNet Pathway to Prevention study screening

Procedures involved:

  • Willing to give informed consent/assent
  • Annual visits (1 autoantibody): blood draw
  • Semi-annual visits (≥ 2 autoantibodies): 2 hour OGTT involving placement of IV and drinking a glucose beverage after an 8 hour fast

Compensation:

  • Provided

Principal investigator: Andrea Steck, MD

Study coordinator: Betsy Burke, RN, 303-724-6766

​COMIRB #: 06-0420

A Twin Family Study of Islet Cell Autoimmunity

Inclusion criteria:

  • ​Twins affected with type 1 diabetes, unaffected twins, their non-twin siblings, and parents
  • Type 1 diabetes in the affected twin/first degree relative is defined as onset < age 40 and the use of daily insulin therapy within one year of diagnosis
  • Ages 6 months to 80 years

Procedures involved:

  • Blood draw – approximately 4 teaspoons (20 ml) every 6-24 months
  • Cheek swab

Compensation:

  • Provided

Principal investigator: Andrea Steck, MD

Study coordinator: Alexandra Fouts, 303-724-6774

​​​COMIRB #: 16-1912

Simponi to Arrest β-cell Loss in Type 1 Diabetes

Inclusion criteria:

  • ​Males and females ages 6-21 years
  • Diagnosed with type 1 diabetes less than 100 days ago
  • In general good health with no other chronic diseases

Procedures involved:

  • Study duration of 2 years
  • Receive injections of Golimumab or placebo every 2 weeks for 1 year (option to self-administer at home) then 1 year of follow up
  • 7 mixed meal tolerance tests over the course of the study
  • Continual use of study-provided glucometer and eDiary

Compensation:

  • Provided

Principal investigator: Andrea Steck, MD

Study coordinator: Betsy Burke, RN, 303-724-6766