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