Type 1 Diabetes Clinical Trials
Understanding Type 1 Diabetes Clinical Trials
Teplizumab (Tzield), approved in 2022, became the first drug proven through clinical trials to delay the onset of type 1 diabetes in high-risk individuals — a historic breakthrough that marked the first time any therapy could alter the disease's course before it fully developed. This approval was built on years of trial data showing that a single 14-day course of the drug delayed clinical diagnosis by a median of two years. Clinical trials in type 1 diabetes are now pursuing even more ambitious goals, including preserving insulin-producing beta cells after diagnosis, developing artificial pancreas systems, and working toward biological cures through cell replacement therapies.
Why Consider a Clinical Trial?
Frequently Asked Questions
Common questions about Type 1 Diabetes clinical trials
Yes. While some trials focus on newly diagnosed individuals, many are open to adults who have had type 1 diabetes for years. Technology trials for closed-loop systems and adjunctive therapy trials for drugs used alongside insulin are often open regardless of disease duration. Cell replacement trials are also studying long-term patients.
Many type 1 diabetes trials include pediatric participants, and these trials undergo additional ethical review specifically focused on child safety. Trials in children use age-appropriate dosing and monitoring protocols. Parental consent and, depending on age, the child's assent are both required before enrollment.
This depends entirely on the trial. Technology trials may require you to switch to the study device. Drug trials generally allow you to continue using your current insulin delivery system and CGM, though they may ask you to use a specific CGM for standardized data collection. Ask the study team about device requirements before enrolling.
Cure-oriented trials aim to restore the body's ability to produce insulin, through approaches like beta cell replacement or immune reprogramming. Management trials aim to improve blood sugar control, reduce complications, or decrease the burden of daily disease management. Both types are valuable and serve different goals.
TrialNet offers free autoantibody screening to relatives (ages 2.5 to 45) of people with type 1 diabetes. You can visit the TrialNet website to find a screening location or request an at-home test kit. If autoantibodies are detected, TrialNet provides monitoring and may offer enrollment in prevention trials.
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