NEW YORK– Nanowear, a leader in home-based cardiometabolic digital diagnostics announced that SimpleSense™, a nanotechnology-enabled wearable, mobile and software diagnostics platform, will ingest glucose data from Dexcom G7 Continuous Glucose Monitoring Systems (CGM) time synchronously alongside Nanowear’s previously FDA cleared cardiovascular biomarkers. The continuous combination of glucose readings, blood pressure, ECGs, lung volume, respiration and hemodynamics offer unprecedented real-world and real-time cardiometabolic diagnostic assessments to the pharmaceutical, medtech, biotech, contract-research-organization (CRO) and direct-to-consumer (DTC) research communities.
“Our Nanowear-Dexcom integration and data partnership will be a unique offering in clinical research,” says Venk Varadan, CEO and Co-founder of Nanowear. “With the addition of CGM, our platform of 85+ cardiopulmonary and hemodynamic biomarkers now becomes the first-and-only self-administered cardiometabolic assessment of 9 combinatorial, time synchronous diagnostic tools and structured data channels through a single app, iOS or Android. There is high demand in the CRO and DTC research communities for a true home-based cardiometabolic assessment that can be self-administered – sponsors want to uncover novel correlative diagnostics utilizing our proven AI approaches in cardiometabolic health.”
Cardiometabolic health is defined as the combination of risk factors for cardiovascular disease. Cardiometabolic conditions such as obesity, diabetes and hypertension are the leading causes of death and illness in the United States and recent studies have shown that since 1999, only 6.8% of Americans have optimal cardiometabolic health. “Quantifying cardiometabolic health with real-world evidence is swiftly becoming the new frontier in cardiovascular research,” says Ami Bhatt MD, Chief Innovation Officer at American College of Cardiology (ACC). “This ability to measure and understand these relationships moves us closer towards early diagnosis and individualized preventative care.”
With expanding indications for cardiometabolic therapeutics such as GLP-1s and renal denervation, the pharmaceutical, medtech, biotech and direct-to-consumer research communities are seeking novel assessment and diagnostic solutions to understand the safety and efficacy of their products in terms of cardiometabolic effects.
“Therapeutics or devices in the Phase II or Phase III research phase constantly affect blood sugar levels and blood pressure levels,” says Mehdi Adineh, VP of Core Labs Innovation at Medpace (NSDQ: MEDP), one of the world’s leading pharmaceutical and biotech CROs. “Our sponsors as well as FDA seek a deeper understanding of these effects in sub-population analyses while clinical trial participants are at home, as opposed to analyses from in-person assessments with 9 traditional diagnostic tools that are not continuous or real world. New technologies like Nanowear can accelerate pharmaceutical and biotechnology companies’ insights into individualized safety and effectiveness of their next-generation therapies.”
