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Xtalks, Online
2024-05-07
Newer 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 managers have to 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 and allowing for the characterization of hypoglycemia triggered by continuous glucose monitoring (CGM) in some diabetes trials to be incorporated as a novel endpoint1.
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In this webinar, attendees will gain insights into current recommendations for monitoring cardiometabolic disease in clinical trials, the complexities and configurability required to continuously monitor patients in this diverse therapeutic area and how clinical trial compliance can be optimized with behavioral modification and lifestyle standardization tools.
Register for this webinar today to gain insights about GlucoseReadyTM, a comprehensive digital platform for capturing clinical data related to cardiometabolic diseases.
1 Food and Drug Administration (2023): Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry, https://www.fda.gov/media/168475/download
Keywords: Clinical Trials, Obesity, Diabetes, Clinical Research, Biomarkers, NASH, Digital Health, NAFLD, Clinical Data, Therapeutic Areas, Metabolic Disease, Weight Loss, GLP-1 Agonist, Other Software, MASH
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Organized by:
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Xtalks |
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Invited Speakers:
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David Anderson, PhD, Principal Scientist, Clinical Ink
Kevin Dolgin, Co-Founder, Observia Group
Thomas Dougherty, Data Science & AI Innovative Partnership Lead, NovoNordisk (Webinar Moderator)
Jonathan Goldman, MD, CEO, Clinical Ink
Steve Polyak, PhD, VP, Engineering and Data, Clinical Ink
Michael Spence, Senior Director Clinical Laboratory Sciences, Eli Lilly
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Deadline for Abstracts:
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2024-05-07
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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