Type 1 Diabetes Research Study
Researchers at the University of Colorado’s Barbara Davis Center are conducting a clinical study on an investigational medication for young people diagnosed with type 1 diabetes within the last 3 months.
Fast Facts
Diagnosed With Type 1 Diabetes Within The Last 3 Months
12-21
Years Old
Compensation
Provided Up To $2730
Conducted in
Denver, CO
Study Background
This study is testing whether a new investigational medication can help protect insulin producing cells in teens and young adults newly diagnosed with type 1 diabetes.
Type 1 diabetes is a condition in which the immune system attacks the cells in the pancreas that make insulin. Even after diagnosis, many young people still have some remaining insulin producing cells, which may help stabilize blood sugar. This study is exploring whether an investigational drug called frexalimab can protect these cells and improve blood glucose control compared to standard insulin therapy alone.
Frexalimab is a monoclonal antibody that may reduce or slow damage to insulin producing cells. Participants in this study will receive either frexalimab or placebo along with their regular type 1 diabetes care. The results will help researchers understand whether frexalimab leads to better outcomes such as lower insulin needs, improved HbA1c, and better blood glucose stabilization.
Study Background
This study is testing whether a new investigational medication can help protect insulin producing cells in teens and young adults newly diagnosed with type 1 diabetes.
Type 1 diabetes is a condition in which the immune system attacks the cells in the pancreas that make insulin. Even after diagnosis, many young people still have some remaining insulin producing cells, which may help stabilize blood sugar. This study is exploring whether an investigational drug called frexalimab can protect these cells and improve blood glucose control compared to standard insulin therapy alone.
Frexalimab is a monoclonal antibody that may reduce or slow damage to insulin producing cells. Participants in this study will receive either frexalimab or placebo along with their regular type 1 diabetes care. The results will help researchers understand whether frexalimab leads to better outcomes such as lower insulin needs, improved HbA1c, and better blood glucose stabilization.
Additional Information
The study aims to find out whether frexalimab can protect insulin-producing cells and improve blood glucose control in young people who were diagnosed with type 1 diabetes within the last 3 months.
You/your teen may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 12-21
- Diagnosed with type 1 diabetes within the last 3 months
- Not receiving any treatment for type 1 diabetes other than insulin therapy
- Not pregnant or breastfeeding
First, you will complete a phone screening to confirm eligibility.
If eligible, you will attend a screening visit at the Barbara Davis Center.
The first treatment visit lasts 6 to 8 hours and includes a mixed meal tolerance test (MMTT) and an infusion of frexalimab or placebo.
You will return every two weeks for injections until week 6. After that, injections may be done at home.
You will come to the clinic about every three months for safety checks, study tests, and to receive medication.
Study procedures may include MMTTs, physical exams, and blood and urine collection.
After the treatment period ends, you will return for safety follow up visits every three months for about six months.
Participants can receive up to $2730 for completing all study visits. You may also receive mileage reimbursement and, if traveling from more than 50 miles away, a free hotel stay. Participants receive a snack at fasting visits, consultations with a diabetes educator and physician at each visit, and intensive diabetes management throughout the study.
There is no cost for you to participate in our research study.