There are nuances in how Type 1 and Type 2 diabetes are studied, including the endpoints and outcome measures. Traditionally HbA1C has been used as the key measure of success for Type 1 and insulin-treating Type 2 diabetes.
However, with the increasing use of continuous glucose monitors (CGM) in clinical practice to track hypoglycemia, diabetes clinical trials are starting to use data collected through CGM to complement HbA1c findings.
While continuous glucose monitors (CGM) offer unique advantages for diabetes clinical trials, there are also many challenges that must be considered including:
When implementing CGM into your study, it is important to work with a technology partner that not only offers a solution to capture and analyze a continuous data stream.
The clinical expertise to understand the outcomes being measured is critical to navigate any operational or regulatory challenges that may arise.
Clinical ink securely collects and stores continuous data streams directly from CGM sensors/transmitters made immediately available to sponsors for timely access. As part of our CGM solution, we provide in-depth data reports and visualizations for site staff access, review, and insight.
Unlike infrequent HbA1C measurements, CGMs provide continuous data, offering a more accurate assessment of patients’ disease status and additional day-to-day context for better analysis.
In addition to its CGM technology, Clinical ink offers a comprehensive eSource solution that incorporates data collection tools and offers a better patient experience, eliminating transcription errors, enabling real-time data analysis, and expediting study timelines.
Simplify and speed study startup, standardize processes, and empower patients.
Document lifestyle activities such as exercise, medications, and carbohydrate intake that may impact blood glucose levels.
Benefit from an easy, efficient, holistic telehealth solution and improve remote monitoring.
Enrich advanced clinical trial data collection with a variety of sensors and wearables solutions.
Watch our panel of clinical experts addressing the recent FDA guidance on using CGM to measure hypoglycemia in clinical trials as a novel endpoint. Explore how patient-centered technology can benefit both sponsors and patients.
Sales and Solutions
Direct 1.336.464.0697
Support
Toll-Free 1.800.301.5033
Direct 1.336.464.0697
Insert HTML text here.
Request more information, submit questions, set up a demonstration, and more.
