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:
Skin Biopsies for the Generation of Disease-Specific Stem Cells
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.
Reimbursement:
none
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425 or email sjp2174@columbia.edu
Study of Immune Function in Type 1 Diabetes: Subjects Wanted to Undergo Bone Marrow Aspiration
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
TrialNet Type 1 Diabetes 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 consent form and assent form.
Time Commitment:
One-time blood test.
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425 or email sjp2174@columbia.edu
TUDCA: Clinical Investigation of Efficacy of Taurourodeoxycholic Acid to Enhance Pancreatic Beta Cell Survival In Type 1 Diabetes by Reducing ER Stress
Purpose of Study
To evaluate the effect of TUDCA on beta cell survival in patients with new onset T1D. NO LONGER ENROLLING.
Age:
18-45
Reimbursement:
$200
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425or email sjp2174@columbia.edu
Type 2 Diabetes Onset in Adolescence and Youth: Genetics Study
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
Contact:
Patricia Kringas, RN at (212) 851-5489 or email mpk40@columbia.edu
GRADE Study (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness)
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
Reimbursement:
You will receive two medicines and four annual medical visits free of charge for the length of the study—and all the diabetes support and education you need to structure a healthy lifestyle and experience good diabetes control and management.
Contact:
Patricia Kringas, research coordinator at (212) 212-851-5489or email mpk40@columbia.edu
CTLA-4 Ig (Abatacept) For Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
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.
Reimbursement:
$25 per visit for short visits and $50 per visit for long visits.
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425or email sjp2174@columbia.edu
Type 1 Diabetes TrialNet Long-Term Investigative Follow-Up (LIFT) Study
Type of diabetes:
Type 1 diabetes
Reimbursement:
$25 per visit
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425or email sjp2174@columbia.edu
SENCE
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.
Type of diabetes:
Type 1 Diabetes
Age:
2-7
Reimbursement:
Compensation will be provided
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425or email sjp2174@columbia.edu
CITY
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.
Type of diabetes:
Type 1 Diabetes
Age:
14 to 24
Reimbursement:
Compensation will be provided
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425or email sjp2174@columbia.edu
HYCLO
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
Reimbursement:
Compensation will be provided
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425or email sjp2174@columbia.edu
EXTEND
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
Reimbursement:
Compensation will be provided
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425or email sjp2174@columbia.edu
SUNRISE
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.
Reimbursement:
$100.00 gift card for each completed clinic visit (there are 22 total) and some travel expenses if pre-approved
Contact:
Sarah Pollak, RN, MS, CCRC at (212) 851-5425or email sjp2174@columbia.edu
