The Barbara Davis Center plays a critical role in trials to provide new therapies and devices to our patients. If you are interested in participating in trials focused on the development of new technologies for insulin delivery systems and blood glucose monitoring, please contact

Cari Berget at 303-724-8977

cari.berget@cuanschutz.edu

COMIRB #: 03-394

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

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: Morgan Sooy, (303) 724-5686

 

COMIRB #: 18-0271​

• ​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:

Principal investigator: Andrea Steck, MD

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

 

COMIRB #: 18-1286​

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)

 

COMIRB #: 15-1352​

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 #: 19-0489

 

• COMIRB #: 20-2610
• Purpose of the research study:
• To investigate the safety and tolerability of ascending subcutaneous weekly doses of NNC0361-0041 plasmid in patients with T1D
• Inclusion criteria:
• Participants age 18-45
• Must have a diagnosis of T1D for less than 48 months at randomization
• HbA1c ≤8.5% at screening
• Procedures involved:
• 12 consecutive weekly doses of study medication given onsite
• 48 hour inpatient hospital stay following the first dose of medication
• Mixed Meal Tolerance Test at screening, the end of treatment and once every 6 months during follow-up
• EKGs
• Duration of participation
• Total duration of 1 yr and 1 month
• First dosing visit will include a 48hr inpatient stay
• Dosing visits 2-6 will last between 4 and 8 hours
• Dosing visits 7-12 will last between 2-4 hours
• Compensation:
• Compensation provided
• Principal investigator: Peter Gottlieb, MD
• Study coordinator: Morgan Sooy, 303-724-5686

 

• COMIRB #: 20-2220
• Purpose of the research study:
• To assess the safety, steady-state pharmacokinetics and the pharmacodynamic effect of blocking self-antigen presentation of multiple doses of IMT-002, D-methyldopa, in subjects with DQ8+ (Genotype) and T1D.
• Inclusion criteria:
• Participants age 18-45
• Diagnosis of T1D according to ADA criteria
• Positive for at least one gene encoding for HLA-DQ8 (DQB*0302), identified during pre-screening
• Procedures involved:
• Capsules taken by mouth for 14 days
• Genetic HLA typing at pre-screening
• ECG
• Blood work to assess safety and efficacy endpoints
• ​Duration of participation:
• Total duration 2 months
• ​Compensation:
• Compensation provided
• Principal investigator: Halis Akturk, MD
• Study coordinator: Brenda Bradfield, 303-724-8595