Our Clinical Trials

Clinical trials are an important aspect of our research and we have a very active roster. 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.

Click here to support clinical trials at the Berrie Center. 

An inside track to our clinical trials

Clinical trials are going on at the Berrie Center all the time. Here are some that are currently enrolling patients. Many patients enroll in trials when their doctors think they may benefit. 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

Study of Immune Function in Type 1 Diabetes: Subjects Wanted to Undergo Bone Marrow Aspiration (Closed)

Purpose of Study

The aim of this study is to identify immune alterations that characterize type 1 diabetes.

Type of diabetes:

Subjects with type 1 diabetes and non-diabetic healthy subjects with no family history of diabetes are eligible.

Age:

18 and older

Time Commitment:

2 Berrie Center visits; 1 visit for blood draw and return visit for bone marrow aspirate.

Reimbursement:

$25 for visit 1 and $250 for visit including bone marrow aspirate.

Contact:

Sarah Pollak, RN, MS, CCRC at (212) 851-5425 or email sjp2174@columbia.edu

Skin Biopsies for the Generation of Disease-Specific Stem Cells (Closed)

Purpose of Study

The aim of this study is to develop stem cell lines that have the characteristics of people with diabetes.

Type of diabetes:

Patients with type 1 diabetes or MODY

Age:

>1 year of age

Time Commitment:

Subjects will have a skin biopsy (1/8 inch in diameter) and a blood draw at a Berrie Center visit.

TUDCA: Clinical Investigation of Efficacy of Taurourodeoxycholic Acid to Enhance Pancreatic Beta Cell Survival In Type 1 Diabetes by Reducing ER Stress (Closed)

Purpose of Study

To evaluate the effect of TUDCA on beta cell survival in patients with new onset T1D. NO LONGER ENROLLING.

Who is eligible for this study?

10 visits over 18 months ages 18-45. 

Age:

18-45

Type 2 Diabetes Onset in Adolescence and Youth: Genetics Study (Closed)

Purpose of Study

The aim of this study is to identify the genes responsible for adolescent-onset type 2 diabetes.

Age:

Any age; diabetes onset prior to age 18

GRADE Study (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness) (Closed)

Purpose of Study

To compare the long-term benefits and risks of four widely used diabetes drugs in combination with metformin, the most common first-line medication for treating T2D.

Type of diabetes:

Patients with type 2 diabetes

Age:

30 years and older

CTLA-4 Ig (Abatacept) For Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus (Closed)

Purpose of Study

To determine whether an investigational agent abatacept (CTLA4-Ig) preserves insulin secretion and pancreatic beta cell function in subjects who have impaired glucose tolerance and are at high risk to develop type 1 diabetes. In this study, abatacept is compared to a placebo.

Funded by the National Institutes of Health 

NO LONGER ENROLLING. 

Type of diabetes:

Type 1 diabetes

Time Commitment:

15 visits during the first year and then twice a year for at least 5 years.

SENCE (Closed)

Purpose of Study

To compare the efficacy and safety of CGM alone and CGM combined with a family behavioral intervention with a control group using home blood glucose monitoring (BGM) alone, and to compare the efficacy of CGM alone with CGM combined with a family behavioral intervention. NO LONGER ENROLLING. 

Who is eligible for this study?

Children between 2 and 7 years of age. 

Type of diabetes:

Type 1 Diabetes

Age:

2-7

CITY (Closed)

Purpose of Study

To assess the efficacy and safety of CGM compared with BGM in adolescents and young adults age 14 to 24 years with type 1 diabetes (T1D). A secondary objective will be to assess the degree of perseverance with CGM use and identify potential factors associated with high and low CGM use to help inform future interventions to enhance CGM use. The latter findings will have relevance for the adoption of future technologies involving automated insulin delivery. NO LONGER ENROLLING.  

Who is eligible for this study?

Young adults age 14 to 24 years with T1D. 

Type of diabetes:

Type 1 Diabetes

Age:

14 to 24

HYCLO (Closed)

Purpose of Study

To evaluate how the 670G closed loop system impacts 21 clinical and patient-reported outcomes in individuals with type 1 diabetes. NO LONGER ENROLLING. 

Type of diabetes:

Type 1 Diabetes

EXTEND (Closed)

Purpose of Study

To see if a drug called Tocilizumab might help people continue to make a little of their own insulin after diagnosis. NO LONGER ENROLLING. 

Type of diabetes:

Type 1 Diabetes

Age:

6-17

Time Commitment:

2 years 

SUNRISE (Closed)

Purpose of Study

To evaluate whether the investigational drug TOL-3021 is safe to use and can preserve insulin production in adult patients with type 1 diabetes.

Type of diabetes:

Type 1 Diabetes

Age:

18-41

Time Commitment:

22 in-person clinic visits over 3 years.

 Weekly at-home treatment.