Open-label: A Source of Innovation in Diabetes Research
By: Erica Caveney, MD | December 16, 2014
That adds safety for patients, but it creates obstacles as dosing insulin is often an art as much as a science. Investigators should be expected to generally follow the insulin titration algorithm. However, they should also be given the leeway to go outside the algorithm when it’s felt to be medical necessary, without fear of committing a protocol violation.
Knowing that fear of hypoglycemia by both subjects and investigators is a common reason subjects get close to goal rather than achieving goal, an insulin titration committee is one way to ensure patients receive appropriate insulin doses within studies. An insulin titration committee, separate from the clinical study team, who oversees insulin dosing on preset criteria can decrease bias, especially is open label studies.
When we run studies for insulin development, an insulin titration committee greatly increases the chance patients achieve the insulin dose that is exactly right for their needs, which has the potential to improve trial outcomes, and patients’ quality of life. And ultimately, that’s the goal of clinical research.