Type 1 Diabetes Research Study
Researchers at the University of Florida are evaluating the safety and efficacy of a medication to delay the loss of beta cells in children recently diagnosed with type 1 diabetes.
Fast Facts
Child ages 8-17
Recently Diagnosed with Type 1 Diabetes
Compensation Provided
Able to Commute to Gainesville, FL - Transportation Provided
Study Background
The University of Florida is seeking volunteers to take part in a clinical research study evaluating the safety and efficacy of a medication for people recently diagnosed with type 1 diabetes.
The purpose of this research study is to learn about a possible treatment to delay the loss of pancreatic beta cells in children with type 1 diabetes (T1D). This study will evaluate the safety and efficacy of the use of frexalimab in children within 100 days of type 1 diabetes diagnosis. For the treatment, your child will be randomly assigned (like the flip of a coin) to receive either real or placebo medication.
If your child chooses to participate, they will be asked to come to our research clinic at the University of Florida for 12 visits. The entire study would last approximately 12 months. During the study, your child will participate in clinical exams, questionnaires, medication administration, continuous blood glucose monitoring, and pregnancy tests (if applicable).
Study Background
The University of Florida is seeking volunteers to take part in a clinical research study evaluating the safety and efficacy of a medication for people recently diagnosed with type 1 diabetes.
The purpose of this research study is to learn about a possible treatment to delay the loss of pancreatic beta cells in children with type 1 diabetes (T1D). This study will evaluate the safety and efficacy of the use of frexalimab in children within 100 days of type 1 diabetes diagnosis. For the treatment, your child will be randomly assigned (like the flip of a coin) to receive either real or placebo medication.
If your child chooses to participate, they will be asked to come to our research clinic at the University of Florida for 12 visits. The entire study would last approximately 12 months. During the study, your child will participate in clinical exams, questionnaires, medication administration, continuous blood glucose monitoring, and pregnancy tests (if applicable).
Additional Information
The purpose of this research study is to evaluate the safety and efficacy of frexalimab in preserving pancreatic beta cell function.
Your child may qualify for this study if they meet the following criteria.
Inclusion Criteria:
- Ages 8-17
- Diagnosed with type 1 diabetes within the last 100 days
- Began taking insulin to treat type 1 diabetes within the last 60 days
- Willing to avoid becoming pregnant or impregnating someone for the duration of the study
- Able to commute to Gainesville, Florida for 12 study visits
Once enrolled, this study involves:
- Attending 12 in-person visits
- Providing your child’s medical history and answering questionnaires
- Completing an ECG
- Using a continuous glucose monitor (CGM)
- Subcutaneous (under the skin) medication administration
- Providing blood samples
- A medical exam
- Pregnancy tests (if applicable)
- Remote phone call check-ins
Your child will receive $100 per visit for their time in participating in the research.
You/your child will also receive reimbursement for meals, mileage, tolls, parking, hotels, flights, and ground transportation that are required for their participation in the research study.
For the total compensation, your child will receive up to $1,200 plus reimbursement for the above expenses.
There is no cost for you or your child to participate in our research study.
