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In this free webinar, attendees will gain insights into current recommendations for capturing key endpoint data in clinical trials of therapies for diabetes, weight management, NASH, and MASH. Panelists will discuss the complexity of digital systems required to continuously monitor symptoms, signs, and digital biomarkers in this diverse patient population. Another key topic with cardiometabolic clinical trials is compliance and dropouts. This can be optimized with behavioral modification and lifestyle standardization tools. The featured speakers will discuss patient-centric platform design, digital profiles, patient biometrics, and compliance.
TORONTO, April 22, 2024 /PRNewswire-PRWeb/ — New treatment options, including glucagon-like peptide-1 (GLP1) agents, are under investigation for treating cardiometabolic diseases such as diabetes, weight management/obesity and metabolic dysfunction-associated steatohepatitis (MASH)/non-alcoholic steatohepatitis (NASH).
Clinical trial sponsors and their CRO partners must address regulatory challenges of capturing behavior, symptoms (electronic clinical outcome assessment [eCOA] and hypoglycemia), physical signs (weight, actigraphy and glucose levels), as well as the practical problems of ensuring compliance and avoiding patient dropouts.
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, arashid@xtalks.com, https://www.xtalks.com
View original content:SOURCE Xtalks
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