The Need to Change Regulatory Evaluation of Hypoglycemia in Trials of Diabetes Treatments

摘要

Diabetes is the most challenging of all hormonal deficiencies to manage because the deficit hormone even when administered with best of care practices and technologies carries substantial risk of hypoglycemia. Treating hyperglycemia while at the same time minimizing the risk of hypoglycemia is an important part of managing diabetes. Hypoglycemia itself and the fear of hypoglycemia prevent the early use of insulin therapy in type 2 diabetes (T2D) and is the major impediment to achieving good glycemic control and avoiding diabetic complication in all people who require insulin therapy. On average, people with longer standing type 1 diabetes (T1D) experience each year about two events of severe hypoglycemia (SH). Up to one in ten patients with T1D will die of hypoglycemia. Hypoglycemia risk in general is highly predictive of mortality in people with T1D. The prevalence estimates for hypoglycemia in T2D range from 1% to 3%.1 Hypoglycemia risk therefore must be a key clinical outcome for any trial that evaluates insulin products, agents with the risk of hypoglycemia, and products that are specifically intended to reduce hypoglycemia risk. Reduction of hypoglycemia risk is also the primary benefit of technologies aimed at managing diabetes, such as insulin pumps and glucose monitoring systems.