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Clinical Research Studies Enrolling



​Clinical Research Studies

COMIRB #: 03-394

Pathway to Prevention Study

Purpose of the research study:

  • Detecting T1D at its earliest stage

Inclusion criteria:

  • People between the ages of 2.5 and 45 with a parent, full-sibling or child with type 1 diabetes

  • People between the ages of 2.5 and 20 with a grandparent, great-grandparent, aunt/uncle, great-aunt/uncle, cousin, 2nd 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 

Principal investigator: Andrea Steck, MD

Study coordinator: 720-346-1034
Please call to schedule and determine walk-in availability as our hours are subject to change due to holidays

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

  • Single Autoantibody: annual blood draw to test for the development of multiple autoantibodies

  • Multiple autoantibodies: annual or semi-annual visits depending on glucose tolerance to a 2 hour OGTT involving placement of IV and drinking a glucose beverage after an 8 hour fast 

Compensation:

  • Compensation may be provided

Principal investigator: Andrea Steck, MD

Study coordinator: Hali Broncucia​ (303) 724-7526

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 provided

Principal investigator: Andrea Steck, MD

Study Coordinator: Sona Seligova​, (303) 724-6774

COMIRB #: 12-1090
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 Prevention or TrialNet Prevention New Onset study
  • Diagnosis of Type 1 Diabetes
  • Ages 1 year and older

Procedures involved: 

  • Willing to give informed consent/assent and 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 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

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: Brenda Bradfield, 303-724-8595

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

COMIRB #: 18-2378
A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in patients with clinical recent-onset Type 1 Diabetes Mellitus (T1D). 
Purpose of the research study:
The research aims to assess the safety and tolerability of different doses of AG109 (the study drug) alone as well as in association with Teplizumab. The study consists of two phases:​
  • Phase 1b: this part of the research will investigate the safety and tolerability of different doses of AG019 in adults and adolescents. All research participants will receive study drug, administered either as single or repeat doses. 
  • Phase 2a: this part of the research will investigate the safety and tolerability of AG019 and Teplizumab in adults and adolescents. Out of the 12 research participents included in each cohort, 10 will receive study drug and 2 will receive placebo. ​
Main Inclusion Criteria:
  • 12-40 years old, weigh more than 33 kg (72.6lb)
  • Diagnosed with Type 1 Diabetes within previous 150 days; have 1 genetic marker for diabetes (islet autoantibody)
  • Presence of a certain amount of C-peptide protein in blood (indicates some natural insulin production). 
  • Pass drugs of abuse screen
Procedures involved:
Phase 1b:
  • 8-weeks of oral study drug, high or low dose
  • Blood collection
  • ECG
  • Mixed Meal Tolerance Tests (MMTTs)
Phase 2a:
  • 8-weeks of oral study drug, high or low dose
  • 12 day IV infusion of teplizumab 
  • Blood and feces collection
  • ECG
  • CGM placement and e-diaries to capture daily diabetes care
  • 4 Mixed Meal Tolerance Tests (MMTTs)
Study Duration:
  • 12 Months
Compensation:
  • Compensation provided
Principle Investigator: Peter Gottlieb, MD​
Study Coordinator: Mara Kinney  (303) 724-8272

COMIRB 19-0489
PROTECT: Provention Bio's T1D Trial Evaluating C-Peptide with Teplizumab
Purpose of the research study:
To determine whether two courses of Teplizumab administered 6 months apart slow the loss of β cells and preserve β cell function over 18 monnths (78 weeks) in children and adolescents 8-17 years old who have been dianosed with T1D in the previous 6 weeks.

 ​​​Main Inclusion Criteria:
  • 8-17 years old
  • Have a recent diagnosis of T1D
Procedures involved:
  • Two 12-day courses of Teplizumab
  • CGM placement and e-diaries
  • 5 Mixed Meal Tolerance Tests (MMTTs)
Study Duration:
  • 18 months
Compensation:
  • Compensation provided
Principle Investigator: Kimber Simmons, MD
Study Coordinator: Hali Broncucia​ (303) 724-7526