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 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.
| PREVENTION TRIALS |
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PERL(Preventing Early Renal Loss in Type 1 Diabetes)
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Adults ages 18-65 who have had type 1 diabetes
for more than 8 years with a history or presence of microalbuminuria.
Contact:
Victoria Gage: Victoria.Gage@ucdenver.edu orJason Gensler: Jason.Gensler@ucdenver.edu
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| TEDDY (The Environmental Determinants of Diabetes in the Young) |
Newborns with no family history of Type 1 diabetes. Young siblings and offspring of persons with type 1 diabetes.
Enrollment Complete |
| DAISY (The Diabetes Auto Immunity Study in the Young) |
The DAISY Study is a unique research study at the University of Colorado Health Sciences Center following children at an increased risk of developing type 1 diabetes. The purpose of the study is to determine if there are any environmental factors that trigger type 1 diabetes. Enrollment Complete
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| 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. |
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| 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. |
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| 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. |
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| TrialNet: TN10 Anti-CD3 (Teplizumab) Prevention |
Relatives, ages 8-45, of people with type 1 diabetes who have been screened through the Natural History Study who have been to be at increased risk for developing Type 1 Diabetes Mellitus |
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| 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 auto antibodies. Twins who are concordant for type 1 diabetes may be included in the study if one twin was tested for auto antibodies prior to the development of diabetes, as may be the case for subjects in DPT-1 or TrialNet. |
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| Determinants of Macro vascular 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. |
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| Wish |
Enrollment Complete |
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| Outpatient Reduction of Nocturnal Hypoglycemia By Using algorithms and Pump Suspension |
Children and adults with Type 1 Diabetes who use wear an insulin pump and CGM and are interested in using a computer to help regulate blood sugars overnight at home.
Contact:
David Maahs: David.Maahs@ucdenver.edu
Peter Chase: Peter.Chase@ucdenver.edu |
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| Treat to Range Controller |
Children and adults with Type 1 Diabetes who wear an insulin pump and CGM and are interested in testing computer systems that help regulate blood sugars in a hospital setting.
Contact:
Rob Slover: Robert.Slover@ucdenver.edu
David Maahs: David.Maahs@ucdenver.edu |
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| INTERVENTION TRIALS |
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Restoring Insulin Secretion (RISE) study
This study is aimed at testing whether early treatment is beneficial to kids with early type 2 diabetes and kids at high risk of diabetes. |
Adolescents 10-19 years of age, pubertal, overweight, fasting glucose: >90 mg/dl, impaired glucose tolerance: >140 mg/dl, prediabetes or diagnosed with diabetes for less than 6 months.
Contact:
Susan Gross: 720-777-6143 susan.gross@childrenscolorado.org
Rose Morehead: 720-777-4354 rose.morehead@childrenscolorado.org |
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Effects of Metformin On CardiovasculaR Function In AdoLescents with Type 1 Diabetes (EMERALD), a research study about Metformin and Type 1 Diabetes in Adolescents |
Adolescents with Type 1 Diabetes who are 12-21 years of age; non-smoking; exercise no more than 3 hours a week; be willing to take Metformin or placebo (sugar pill) for 3 months
Contact:
Amy West: 720-777-5774 amy.west@childrenscolorado.org |
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| Metabolic Control Study |
Enrollment Complete |
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| T1DAL (Type 1 Diabetes and Alefacept) |
Diagnosed with type 1 diabetes within the past 3 months, ages 12-35 |
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| RETAIN STUDY: a research trial of Aralast in new-onset type 1 diabetes |
Diagnosed with type 1 diabetes within the past 3 months, ages 8-35
Phase 1: Enrollment complete
Phase 2: coming 2012 |
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| ATG-GCSF: Reversing type 1 diabetes after it is established: A pilot safety and feasibility study of Thymoglobulin and Neulasta in established type 1 diabetes |
Ages 16-45 with a diagnosis of Type 1 diabetes for at least 4 months but less than 2 years |
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| Effect of Antithymocyte Globulin (ATG) on Preserving Beta-Cell Function in New Onset Type 1 Diabetes Mellitus |
Type 1 diabetes diagnosis within 100 days.
12-35 years old. Enrollment complete
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| Vytorin And Simvastatin Trial (VAST) |
Enrollment Complete |
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| TolerX (TTEDD) Cohort 5 |
Enrollment Complete |
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| Randomized Study of Real-Time Continuous Glucose Monitors in the Management of Type 1 Diabetes |
Enrollment Complete
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| Effects of GAD on the Progression of Type 1 Diabetes in New Onset Subjects (The GAD65 Research Study) |
Enrollment Complete |
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| DEFEND-I: Phase 3 Trial of Otelixizumnab for Young Adults With Newly Diagnosed Type I Diabetes Mellitus |
Enrollment Complete |
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| Phase II trial of hOKT3g1(Ala-Ala), Teplizumab, for treatment of patients with recent onset Type 1 diabetes mellitus (Delay Study) |
Enrollment Complete |
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| AbATE Type 1 Diabetes Trial for New Onset Diabetes |
Enrollment Complete |
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| TrialNet: Effect of CTLA-4 Ig (Abatacept) on the Progression of Type 1 Diabetes in New Onset Subjects |
Enrollment Complete |
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| Phase I Study of BHT-3021 in Subjects with Type 1 Diabetes |
Enrollment Complete |
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| TolerX Type 1 Diabetes Trial |
Enrollment Complete |
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