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Clinical Research Studies Enrolling



​Clinical Research Studies

COMIRB #: 12-1578

Abatacept Prevention Study

Purpose of the research study:

  • To determine whether a drug called abatacept can delay or prevent disease progression in Stage 1 Type 1 Diabetes between the ages of 6 to 45

Inclusion criteria:

  • Stage 1 type 1 diabetes (individuals testing positive for two or more diabetes-related autoantibodies, but with no symptoms and normal blood sugar) between the ages of 6 to 45

Procedures involved:

  •  14 intravenous infusions (3 in the first month, then monthly) over the course of one year

Duration of Participation:

  • ​​5-6 years

Compensation:

  •  Provided

Principal investigator: Peter Gottlieb, MD

Study coordinator: Lexie Chesshir, 303-724-1755

COMIRB #: 03-394

Pathway to Prevention Study

Purpose of the research study:

  • Detecting T1D at its earliest stage

Inclusion criteria:

  • ​People between the age of 1 and 45 with a parent, brother, sister, or child with type 1 diabetes

  • People between the age of 1 and 2 with a grandparent, aunt/uncle, cousin, niece/nephew, or half-sibling with type 1 diabetes

Procedures involved:

  • A simple blood test is all it takes to learn your risk.

Duration of participation:

  • Ongoing

Compensation:

  • No compensation provided for screening

  • Compensation provided for monitoring

Principal investigator: Andrea Steck, MD

Study coordinator: Joyce Chun, 720-346-1034
Please note that screening for the Pathway to Prevention Study will end at noon on Wednesday, November 21st. If you or a family member would like to get screened on this day, please plan accordingly.

COMIRB #: 03-394

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

Purpose of research study:

  • To determine the relative contribution of genetic and environmental factors to the early stages of and progression to type 1 diabetes and related autoimmune diseases

Inclusion criteria:

  • Eligible participants include twins affected with type 1 diabetes and unaffected twins, non-twin siblings and parents. Type 1 Diabetes in the affected participant is defined as onset <40 years old and the use of daily insulin therapy within one year of diagnosis. Participants must be between 6 months and 80 years old. 

Procedures involved:

  • A blood draw will be done to obtain DNA and serum samples. Samples are analyzed for diabetes autoantibodies, other autoantibodies, and markers associated with risk of developing diabetes.

  • A swab of the inside of the cheek might also be collected for DNA. Same sex twins will be tested for genes to verify if they are identical or fraternal.  

Duration of participation:

  • The first visit will take about 30 minutes. Depending on the results of the tests, participants will be asked to come in for a visit every 6-12 months. The study will continue until the participant withdraws or until funding is stopped.​

Compensation:

  • Compensation not provided

Principal investigator: Andrea Steck, MD

​​​COMIRB #: 16-1912

Simponi to Arrest β-cell Loss in Type 1 Diabetes

Purpose of research study:

  • To determine if Simponi (golimumab) can preserve β-cell function in children and young adults with newly diagnosed type 1 diabetes (T1D)

​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:

  • Receive injection 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, test strips, and eDiary

Duration of participation:

  • 24 months

Compensation:

  • Compensation provided

Principal investigator: Andrea Steck, MD

Study coordinator: Hali Broncucia, 303-724-7526

COMIRB #: 10-1074
Anti-CD3 MAB (Teplizumab) for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Purpose of research study:
  • To see if 14 consecutive days of the study drug, Teplizumab, can delay or prevent Type 1 Diabetes in relatives at risk for developing the disease
Inclusion criteria:
  • Be a participant in the TrialNet Pathway to Prevention study

  • Ages 8-45 years

  • Positive for 2 or more diabetes related autoantibodies

  • Abnormal Oral Glucose Tolerance Tests (OGTTs)

Procedures involved:
  • Willing to give informed consent/assent

  • Willing to receive an infusion for 14 days in a row

  • Willing to participate in follow up visits every 3-6 months

Duration of participation:
  • NOT ENROLLING
Compensation:
  • Compensation provided

Principal investigator: Peter Gottlieb, MD

Study coordinator: Hali Broncucia, 303-724-7526

Long Term Investigative Follow-up in TrialNet (LIFT)
Purpose of research study:
  • ​To help us learn more about factors involved in preservation of insulin production after being diagnosed with Type 1 Diabetes

Inclusion criteria:

  • Participated in the TrialNet Pathway to Prevention study or TrialNet Prevention/New Onset studies
  • Diagnosis of Type 1 Diabetes
  • Ages 1 year and older

Procedures involved: 

  • Willing to give informed consent/assent
  • 2-hour Oral Glucose Tolerance Test (OGTT) – involves the placement of an IV and drinking a glucose beverage after an 8-hour fast
-or-
  • 2-hour Mixed Meal Tolerance Test (MMTT) – involves the placement of an IV and drinking a Boost beverage after an 8-hour fast

Duration of participation:

  • Long term follow-up
Compensation:
  • ​Compensation provided

Principal investigator: Andrea Steck, MD

Study coordinator: Hali Broncucia, 303-724-7526

A Prospective Randomized Placebo-Controlled Double Blind Clinical Trial to Evaluate the Safety and Efficacy of CLBS03 (Autologous Ex Vivo Expanded Polyclonal CD4+CD25+CD127lo/-FOXP3+ Regulatory T-cells [Tregs]) in Adolescents with Recent Onset Type 1 Diabetes Mellitus (T1DM)

Purpose of research study:

  • This study involves strengthening and increasing the protective (T- Regulatory) cell population in the immune system through a process done to the blood at a sterile manufacturing facility in California. Now as an investigational product (IP), it will be low dose, high dose, or placebo, and given to the patient through an IV at Visit 3 over 30 mins.  

Inclusion criteria:

  • ​Diagnosed with T1D for <100 days from study treatment date
  • Age: 8 - <18 years old
  • > 30 kg at time of screening
  • Insulin as only diabetes drug
  • No participation in any other investigational drug clinical trials in the last 90 days or during participation in this study

Procedures involved:

  • The study entails 9 more visits, occurring more frequently in the beginning, and tapering off to 3- and 6-months between visits as the patient progresses in the study.
      • 1 blood collection procedure followed exactly 15 - 16 days later with infusion of IP
      • Blood draws for lab tests
      • Mixed Meal Tolerance Tests requiring 10-16 hour fasting
      • 12 visits over 2 years, all at the BDC
      • ​Tracking blood glucose and insulin use at home as required by the study

Duration of participation:
  • ​24 months
Compensation:
  • Compensation provided

Principal investigator: Peter Gottlieb, MD

A Phase 1b Study to Evaluate an Investigational Medication in Children, Adolescents, and Young Adults with Pre-Symptomatic Type 1 Diabetes
Purpose of the research study:
  • ​To determine the safety and tolerability of an investigational medication in children, adolescents, and young adults with pre-symptomatic Stage 2 Type 1 Diabetes (T1D)
Inclusion criteria:

  • ​Males and females ages 6-21 years
  • Positive for at least 2 of the following diabetes-related autoantibodies obtained at study screening: GADA-65, IA-2A, ZnT8, ICA, IAA
  • In general good health with no other chronic diseases

Procedures involved:

  • 14 doses of the investigational medication administered as a subcutaneous injection (option to self-administer at home) 
  • 5 Oral Glucose Tolerance Tests over the course of the study
  • Use of study-provided continuous glucose monitor (CGM) and Diary​

Duration of participation:
  • 18 months
Compensation:
  • Compensation provided

Principal investigator: Andrea Steck, MD

Study coordinator: Hali Broncucia​, 303-724-7526

COMIRB #: 18-1286​
Hydroxychloroquine Prevention Study
Purpose of the research study:
  • To determine whether the drug hydroxycholoroquine (HCQ) can prevent or delay disease progression in participants age 3 or older who have two or more diabetes-related autoantibodies and normal glucose tolerance (Stage 1 Type 1 Diaetes TT1D))
Inclusion criteria:
  • Participants age 3 or older
  • Postiive for two or more AAB and normal glucose tolerance (Stage 1)
Procedures involved:
  • Capsule taken by mouth as instructed until progression to stage 2 T1D (abnormal glucose tolerance) or Stage 3 T1D (diabetes onset)
  • Contact from the study team between site visits to check for symptoms of diabetes
  • Oral glucose tolerance test at the beginning of the study and then every six months
  • Due to a rare risk of eye disease with long term/high dose of HCQ, eye exams are required within 3 months of starting the study and then once a year while on HCQ
​Duration of participation:
  • Initial study visit followed by visits at month 3 and 6, then every 6 months
  • Study visits last about 3-4 hours
​Compensation:
  • Compensation provided
Principal investigator: Andrea Steck, MD
Study coordinator: Betsy Burke, RN, 303-724-6766​
COMIRB #: 15-1352​
MER3101 Research Study: MAS-1 Adjuvanted Antigen-Specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes
Study Sponsor:
The Leona and Harry B. Helmsley Trust, Nova Immunotherapeutics, and the Barbara Davis Center are sponsors for this study. Nova Immunotherapeutics is supplying the study drug.
Purpose of the research study:
To determine if insulin B-chain adjuvant with MAS-1 is safe and will favor tolergenic pathways to restore immunologic balance and reverse T1D autoimmunity
  • Antigen specific therapy (ASI) offers the hope of directing the treatment towards the immune cells causing disease while avoiding other cells of the immune system needed to maintain general health.
  • MAS-1 is a novel adjuvant, which favors the development of many regulatory pathways at once and when combined with a self-antigen such as insulin B chaing (IBC).
  • This study hopes to show that the MAS-1 adjuvant ASI favors the development of anti-inflammatory regulatory pathways, while decreasing auto-inflammatory pathways in an antigen specific way.
​Inclusion criteria:
  • Age 18-45 years
  • Must meet the ADA standard T1DM criteria and be positive for at least 1 islet autoantibody
  • T1DM diagnosed within the previous 2 years
  • Must have stimulated C-peptide levels >/= 0.2 pmol/ml measured during an MMTT at least 21 days from diagnosis
  • HbA1c between 6.0 and 9.5
Procedures involved:
  • 2 IM injections of investigational product
  • 5 MMTTs over the course of the trial
  • Dilated eye exam at the first treatment visit and at the final study visit
Duration of participation:
  • Study duration is approximately 18 months, with treatment occurring over the 1st month and follow up for the remainder of the time.
Compensation:
  • Compensation provided.
​​Principal investigator: Peter Gottlieb, MD​
Study coordinator: Brenda Bradfield​, 303-724-8595