Clinical Trials

Purpose of study

The goal of this study is to see how the experimental study drug, siplizumab, can block or weaken the cells that attack beta cells in the pancreas. This would allow the beta cells to continue to function and produce insulin.

Who is eligible

• Between the ages of 18 and 45
• Have been diagnosed with type 1 diabetes within the last 18 months
• Are in good general health

Time commitment

• DESIGNATE is a 52-week Research Study
  • Treatment period: 3 months (12 weeks), 12 weekly clinic visits (at which the participant receives weekly injections of the study drug)
  • Follow-up Period: 9 months (40 weeks), 4 clinic visits (at weeks 12, 24, 36 and 52)

Reimbursement

• Travel Expenses (All visits): $50 / visit
• Visit -1: $100
• Visits 0, 12, 13, 14, 15: $80 / visit
• Visits 1 – 11, unscheduled: $60 / visit
• Mixed Meal Tolerance Test visits (-1, 12, 13, 14, 15) additional payment: $250 /visit

Contact
Email berrietrials@cumc.columbia.edu.

More Information

Purpose of Study

TrialNet is testing two different Janus kinase (JAK) inhibitors to see if either or both can preserve insulin production in people recently diagnosed with type 1 diabetes (T1D). The two JAK inhibitors being tested in this study are abrocitinib and ritlecitinib. To understand which treatment works best, participants will be randomly assigned to one of three groups: one group will get abrocitinib, one will get ritlecitinib, and one will get a matching placebo (looks like the study treatment but has no active ingredients).

Who is Eligible

This study is enrolling people who are:

• Age 12-35
• Newly diagnosed with T1D (in past 3 months)
• Up to date on required vaccines (including the flu vaccine when it is available)
• Not pregnant, breastfeeding or planning to become pregnant while in the study
• AND have:
  • One or more diabetes-related autoantibodies
  • Hemoglobin A1C below 10%
  • C-peptide detectable during a mixed-meal tolerance test (MMTT)

Contact
Email: berrietrials@cumc.columbia.edu

More Information

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.

Purpose of study

TrialNet is testing whether a medicine, low-dose anti-thymocyte globulin (ATG), can delay or prevent type 1 diabetes (T1D) in people who are at a high risk for developing T1D within 2 years. A previous TrialNet study in people newly diagnosed with T1D found that ATG may help people continue to make insulin and improve blood sugar levels, measured by a test called hemoglobin A1C (HbA1c).

Who is eligible

STOP-T1D Prevention Study participants are:

• Between the ages of 12 and up to 35
• have a 50% risk of developing T1D within 2 years, as defined by having two or more diabetes-related autoantibodies and abnormal blood sugar levels (Stage 2), plus at least one of the following high-risk markers:
  • Hemoglobin A1C between 5.7 and 6.4%
    (a measure of average blood sugar levels over the past 3 months)
  • Index60 equal to or greater than 1.4
    (a measure of how much insulin the body is making on its own)
  • DPT Risk Score (DPTRS) equal to or greater than 7.4
    (a measure of risk based on blood sugar levels, age, BMI, and how much insulin the body is making on its own)
• Up to date on recommended vaccines, including COVID-19 and flu
• NOT pregnant or planning to become pregnant while participating in the study

Contact
Email: berrietrials@cumc.columbia.edu

More Information

Purpose of Study
TrialNet is studying the use of rituximab-pvvr and abatacept, one after the other, to learn if using both treatments extends insulin production in people newly diagnosed with type 1 diabetes (T1D). Previous studies with similar treatments showed people can make more insulin for a longer period of time while receiving either of the treatments. T1D RELAY will study if two treatments consecutively performs better than rituximab-pvvr alone. Researchers will test if those who are also treated with abatacept have better C-peptide levels over time.

Who is Eligible

This study is enrolling children and adults who are:

• Age 8-45
• Newly diagnosed with T1D (in past 3 months)
• Up to date on required vaccines (including the flu vaccine when it is available)
• Not pregnant, breastfeeding or planning to become pregnant while in the study
• AND have:
  • 1 or more diabetes-related autoantibodies
  • C-peptide detectable during a mixed-meal tolerance test (MMTT)

Contact
Email: berrietrials@cumc.columbia.edu

More Information

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 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, 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 of diabetes
Type 1 diabetes

Reimbursement
$25 per visit 

Contact
Email berrietrials@cumc.columbia.edu.

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

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