Regulatory strategy for the evolving diabetes device market
We support continuous glucose monitors, insulin delivery systems, and metabolic devices through FDA's evolving regulatory landscape. BSC's comparative effectiveness expertise and real-world evidence capabilities position your device for both regulatory approval and market differentiation.
Diabetes & Endocrinology
Overview
BSC supports the development of diabetes management technologies, continuous glucose monitoring systems, insulin delivery devices, and other treatments for endocrine disorders. Our expertise spans type 1 and type 2 diabetes, as well as metabolic and hormonal conditions.
Specialized Capabilities
HbA1c analysis and glycemic control endpoint design. Time-in-range analyses for CGM data. Hypoglycemia event adjudication and severity assessment. Closed-loop insulin delivery system statistical design. Long-term diabetes complication modeling.
Regulatory Experience
We understand unique FDA expectations for diabetes devices, including appropriate non-inferiority margins for glucose control, safety assessments of hypoglycemia risk, and integration of patient-reported outcomes. Our team has experience with both ambulatory glucose profile analysis and traditional HbA1c endpoints.
Representative Studies
Continuous glucose monitoring systems.
Insulin pumps and closed-loop systems.
Diabetes management software and algorithms.
Glucose meters and point-of-care testing.
Metabolic disorder treatment devices.