Youth 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 people recently diagnosed with type 1 diabetes.
Fast Facts
Ages 8-21
Diagnosed with Type 1 Diabetes within the past 50 days
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 people with type 1 diabetes (T1D). This study will evaluate the safety and efficacy of the use of frexalimab in people within 100 days of type 1 diabetes diagnosis. For the treatment, you will be randomly assigned (like the flip of a coin) to receive either real or placebo medication.
If you choose to participate, you 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, you 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 people with type 1 diabetes (T1D). This study will evaluate the safety and efficacy of the use of frexalimab in people within 100 days of type 1 diabetes diagnosis. For the treatment, you will be randomly assigned (like the flip of a coin) to receive either real or placebo medication.
If you choose to participate, you 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, you 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.
You and your child may qualify for this study if the following criteria are met.
Inclusion Criteria:
- Ages 8-21
- Recently diagnosed with type 1 diabetes
- Began insulin treatment in the last 50 days
- Willing to use contraception during duration of the study
- Not pregnant or planning to become pregnant
- No previous cancer diagnoses
Once enrolled, this study involves:
- Attending 12 in-person visits
- Providing your 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
You will receive $100 per visit for your time in participating in the research.
You will also receive reimbursement for meals, mileage, tolls, parking, hotels, flights, and ground transportation that are required for your participation in the research study.
For the total compensation, you will receive up to $1,200 plus reimbursement for the above expenses.
There is no cost for you to participate in our research study.
