Recent US Food and Drug Administration (FDA) guidance has underscored these issues by mandating lifestyle standardization for obesity and diabetes clinical trials. In addition FDA is requiring hypoglycemia (either symptomatic or triggered by continuous glucose monitoring (CGM) devices) to be incorporated as a novel endpoint in some diabetes trials.
Sponsors of upcoming clinical trials can select the most appropriate and FDA-compliant approach to capture these endpoints in a single GCP environment. Capturing data is only part of the problem. Lifestyle information and adherence advice must be provided in real time to participants and sites with appropriate feedback loops. Hypoglycemia needs to trigger an e-diary and all data should be available in real time to sponsors and clinical research organizations.
To capture all these data in a single system Clinical ink has developed GlucoseReadyTM, an integrated GCP compliant digital platform. The suite of tools including disease specific electronic clinical outcomes assessments (eCOA), behavioral assessment by the SPUR™ tool, lifestyle standardization, blood (BGM) and continuous glucose monitoring (CGM), digital weight scale and actigraphy. Unique endpoint features include ability of BGM and CGM to trigger hypoglycemia eCOA within the platform.
In this webinar, attendees will obtain recommendations for monitoring cardiometabolic disease in clinical trials and how compliance can be optimized with tracking, behavioral modification and lifestyle standardization tools.
Join panelists Thomas Dougherty, Data Science & AI Innovative Partnership Lead, NovoNordisk (Webinar Moderator); Michael Spence, Senior Director Clinical Laboratory Sciences, Eli Lilly; Jonathan Goldman, MD, CEO, Clinical ink; Kevin Dolgin, Co-Founder, Observia Group; Steve Polyak, PhD, VP, Engineering and Data, Clinical ink; and, David Anderson, PhD, Principal Scientist, Clinical ink, for the live webinar on Tuesday, May 7, 2024, at 11:30am EDT (4:30pm BST/UK).
Media Contact
Ayesha Rashid, Xtalks, +1 (416) 977-6555 x272, [email protected], https://www.xtalks.com
SOURCE Xtalks
