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.