Our Clinical Trials

The Naomi Berrie Diabetes Center is the site for one of the country’s largest programs of clinical trials in type 1 diabetes, particularly those involving children.

"Clinical trials benefit everyone."

Robin S. Goland, MD
Co-Founder and Co-Director

A clinical trial sets out to provide research scientists and doctors with answers to specific questions in a clinical setting. People who volunteer for clinical trials, or studies, play an indispensable role in helping find better ways to prevent, diagnose or treat diabetes. Clinical trials are going on at the Berrie Center all the time. Here are some that are currently enrolling patients. Feel free to discuss a trial with your doctor if you (or your child) fit the description.

Click on the clinical trial for more information:

TrialNet TN01: Pathway To Prevention Study

Purpose of Study

To screen relatives of type 1 diabetes for the antibodies associated with a higher risk of developing type 1 diabetes. Autoantibodies are a sign that the immune system may be attacking the insulin-producing cells in the pancreas. Click to view the related One-Sheeter for the study.

Who is eligible for this study?

1. People 2 years 6 months of age to 45 years of age and have a brother, sister, child, or parent with type 1 diabetes.

2. People 2 years 6 months of age to 20 years of age and have a cousin, aunt, uncle, niece, nephew, half sibling, grandchild with type 1 diabetes.

Time Commitment:

One-time blood test: Capillary (finger-prick) or Venipuncture (blood draw)

If tested positive, followed up annually or semi-annually until progression to Stage 3 T1D

 

Contact:

James Pring at 212-851-5489or email jp3735@cumc.columbia.edu

TrialNet TN22: Hydroxychlorquine Prevention Study

Purpose of Study

To see if hydroxychloroquine (HCQ) can help delay or prevent the progression of Stage 1 diabetes (normal glucose tolerance) to Stage 2 diabetes (abnormal glucose tolerance) or Stage 3 diabetes (clinical diagnosis). The study is a randomized, placebo-controlled study. In this study, 2 out of 3 people will receive active treatment, and others will be given an inactive treatment (placebo). The study treatment is given as a capsule. Click to view the related Participant Handbook for the study.

Who is eligible for this study?

You will be at least 3 years old at the time of randomization in this trial.

You have tested positive for two or more diabetes-related autoantibodies.

You weigh at least 12 kg at the time of screening.

Results of your screening tests show you are eligible.

You don’t have any medical conditions that might make it unsafe for you to be in this study.

You are not pregnant and do not plan to become pregnant while participating in the study.

Time Commitment:

Until progression to Stage 3 T1D

Reimbursement:

$50 depending on the visit plus travel reimbursement

Contact:

Jamie R Hyatt, RN, BSN, CDCES at (212) 851-5425or email jh4470@cumc.columbia.edu

TrialNet TN27: TOPPLE T1D Study – Tolerance using Plasmid

Purpose of Study

To investigate the safety and tolerability of ascending subcutaneous weekly doses of NNC0361-0041 plasmid in patients with T1D. This is a Phase 1 study.  It is the first time the therapy will be tested in people.  If the study results demonstrate that the investigational treatment is safe and impacts the immune system that causes type 1 diabetes, the hope is to study the drug in the future as a possible treatment for prevention of type 1 diabetes. Click to view the related One-Sheeter for the study.

Who is eligible for this study?

You were diagnosed with type 1 diabetes within the last 48 months.

You will be at least 18 years old and at most 45 years old at the time of randomization in this trial.

Results of your screening tests show you are eligible.

You don’t have any medical conditions that might make it unsafe for you to be in this study.

You are not pregnant and do not plan to become pregnant while participating in the study.

Time Commitment:

1 year once enrolled. Additionally, there is a 48-hour inpatient visit followed by weekly visits for 12 weeks.

Reimbursement:

Either $50 or $100 depending on the visit plus travel reimbursement

Contact:

Lucia Alfano, RN at (212) 851-5449 or email lja2141@cumc.columbia.edu

Type 1 Diabetes TrialNet Long-Term Investigative Follow-Up (LIFT) Study

Type of diabetes:

Type 1 diabetes

Reimbursement:

$25 per visit

Contact:

Jamie Hyatt, RN, BSN, CDCES at (212) 851-5425or email jh4470@cumc.columbia.edu

Skeletal Health in Children with Type 1 Diabetes

Purpose of Study

To learn how bone health is affected during the growth spurt in children and adolescents with type 1 diabetes. 

The study is investigating whether bone acquisition is impaired in children and adolescents with type 1 diabetes.  This might occur because high glucose levels can block bone-building activity.  Since the onset of type 1 diabetes is usually during childhood and adolescence, the period during which most of the adult bone mineral content is attained, the timing of the disease might reduce the “peak bone mass,” or the maximum amount of bone that a person can build during their life.  This might increase the risk of a fracture later in life.  

To investigate the impact of type 1 diabetes on bone accrual, the study compares baseline, 1 year and 2 year changes in bone structure, function and strength using bone density tests (dual energy X-ray absorptiometry and high resolution peripheral quantitative computed tomography with bone strength estimation) and blood tests (measuring bone building activity).  These tests are done in 40 children and adolescents with type 1 diabetes and in 40 children and adolescents without type 1 diabetes, beginning at the onset of the pubertal growth spurt. The study is also determining the relationships between changes in bone building and in measures of glycemic control, by using continuous glucose monitoring (CGM).   We expect that from this study information will be gained about how to maximize bone health in children and adolescents with type 1 diabetes during the critical window of peak bone development.   

Type of diabetes:

Type 1 Diabetes

Age:

8-16

Time Commitment:

3 in-person clinic visits over 2 years.  At each visit there is a blood draw and bone density tests. 

Reimbursement:

$100.00 gift card for each clinic visit

Contact:

Rukshana Majeed, research coordinator at 212-305-9489 or email rm3324@cumc.columbia.edu