Clinical Trials
The Naomi Berrie Diabetes Center is home to one of the country’s largest programs of clinical trials in diabetes. Our investigators work tirelessly to better understand the underlying causes of diabetes, and how this condition can be cured, prevented, and better controlled.
A clinical trial sets out to provide research scientists and doctors with answers to specific questions in a clinical setting. Patients who volunteer for clinical trials play an important role in helping find better ways to prevent, diagnose, or treat diabetes. Clinical trials are going on at the Berrie Center all the time. Feel free to discuss a trial with your doctor if you (or your child) fit the descriptions below.
Current Studies
Clinical trials are going on at the Berrie Center all the time. Here are some that are currently enrolling patients.
Type 1 Diabetes
Beta PRESERVE
Purpose of Study
This study is looking at how an investigational study drug, called teplizumab, might possibly help protect insulin-producing cells by affecting the immune cells that attack them. The main goal of the study is to see if teplizumab can work better than a placebo (a look-alike with no medicine in it) in helping people keep their blood sugar in a healthy range or use less mealtime insulin.
Who Can Participate
To join this study, participants must:
- Be 1 to 25 years of age.
- Have been recently diagnosed (within a month) with T1D.
- Be positive for at least one T1D autoantibody.
Contact
RESET-T1D
Purpose of Study
TrialNet is studying rezpegaldesleukin to see if it can help the body continue making insulin in people newly diagnosed with type 1 diabetes (TID) by stimulating regulatory T cells to restore immune balance.
Rezpegaldesleukin is already being studied in people with other autoimmune diseases like psoriasis and eczema. This is the first time it is being studied in people with TID.
Who Can Participate
- Newly diagnosed with T1D (in the past 3 months)
- Ages 18 to 45
- Your screening tests show:
- 1 or more diabetes-related autoantibody
- Detectable C-peptide during a mixed meal tolerance test (MMTT)
Contact
Email: berrietrials@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
Email: berrietrials@cumc.columbia.edu
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. View the related One-Sheeter for the study.
Who Is Eligible
- People 2 years 6 months of age to 45 years of age and have a brother, sister, child, or parent with type 1 diabetes.
- People 2 years 6 months of age to 20 years of age and have a cousin, aunt, uncle, niece, nephew, half-sibling, or 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
Email: berrietrials@cumc.columbia.edu
Type 2 Diabetes
PRECIDENTD
Purpose of Study
To learn more about SGLT2 inhibitors and GLP1 agonists, the only two classes of diabetes medications shown to reduce risk of heart disease for people with type 2 diabetes. We don’t know which medication class works better, or if taking both classes together works better than taking just one.
Who Is Eligible
People with type 2 diabetes who are:
- Over age 40 and have had a heart attack, stroke, or stents to open their blood vessels.
- Over age 60 with A1C above 8, or who smoke.
Time Commitment
- A 1-hour first visit in-person or by video conference. This will help make sure the medicines are safe and affordable for you. If you agree to participate, you will complete questionnaires, have your height and weight taken, and be assigned your medication.
- Follow-up visit or call with study team two months later.
- One survey per year by phone or online between the yearly visits until the study ends in 2028.
- One in-person or video conference visit per year until the study ends in 2028.
Reimbursement
You will be paid $100 for each year that you take part in the study.
Contact
Email: berrietrials@cumc.columbia.edu
Atypical Diabetes
BPCFRD: Insulin-only Bionic Pancreas in CFRD
Purpose of study
The iLet Bionic Pancreas uses a continuous glucose monitor (CGM) and a computer program to automatically deliver insulin through a pump every 5 minutes. The iLet Bionic Pancreas is cleared by the FDA for people with type 1 diabetes. The purpose of the study is to test the insulin-only iLet Bionic Pancreas in people with cystic fibrosis-related diabetes (CFRD).
Who Is Eligible
- People with cystic fibrosis related diabetes:
- 14 years and older
- Taking insulin for at least 3 months
Time Commitment
- The study will last for 26 weeks
- Required study visits can be completed in person or by telehealth if needed
Reimbursement
You will be paid for the screening visit, the main study and extension phase, as well as for any optional substudies that you complete.
Contact
Email:
RADIANT
Purpose of Study
To discover and define rare and atypical forms of diabetes. These refined diagnoses will be used by diabetes researchers, physicians, and patients, to accurately explain their disease. This could also lead to better diagnoses, improved treatments, and potential prevention of these diseases.
Who Is Eligible
You may be eligible for RADIANT if you have been diagnosed by your doctor with diabetes, but do not fit the usual patterns of type 1 or type 2. This may include the following characteristics or symptoms:
- Type 2 diabetes diagnosed in a child before the onset of puberty
- Type 2 diabetes diagnosed in a person of any age who is not overweight
- Strong family history of diabetes in multiple generations, especially with early onset (<18 years old)
- Negative type 1 diabetes autoantibodies
- Evidence of beta cell function, that the body is still producing insulin, more than two years after diabetes diagnosis (you may need have a blood draw to determine this)
- If you have had one or more episodes of diabetic ketoacidosis (DKA) but have been told you do NOT have type 1 diabetes, OR if you have had one or more episodes of DKA but are currently not requiring insulin therapy
Time Commitment
The study has 3 stages. There are two venipuncture blood tests, completed once at the beginning of participation and again if advanced to Stage 2 of the study. If advanced to Stage 3, there is one in-person visit at a study site. Participation may last for several years.
Contact
Email: berrietrials@cumc.columbia.edu
Contact Us
For more information about our clinical trials, please contact our research team at berrietrials@cumc.columbia.edu.
