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 open 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.
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:
Principal investigator: Peter Gottlieb, MD
Study coordinator: Ruthie Williamson, RN, 303-724-6894
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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
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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:
Principal investigator: Andrea Steck, MD
Study coordinator: Betsy Burke, RN, 303-724-6766
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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:
Principal investigator: Andrea Steck, MD
Study coordinator: Alexandra Fouts, 303-724-6774
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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:
Principal investigator: Andrea Steck, MD
Study coordinator: Betsy Burke, RN, 303-724-6766 |