Welcome back to another episode of Real Time Real Talk where this week, host Cher Pastore is joined by Dr Jessica Castle and Dr Stayce Beck to discuss the meticulous process behind the formulation and execution of Continuous Glucose Monitoring (CGM) accuracy trials. The trio discuss the influence of rigorous trial design and transparency on the accuracy and reliability of CGM devices, particularly those developed by Dexcom. They highlight the importance of CGM research's credibility, strategies to minimize bias, and the essential role that regulatory bodies play in ensuring quality health research. The discussion also covers the dynamics of conflicts of interest, patient and healthcare provider education, and the significance of detailed metrics for evaluating CGM performance. Our expert panel also take us behind the scenes to reveal the meticulous work involved in creating and executing CGM studies that encompass different populations and conditions. You’ll hear discussions around key performance metrics in a CGM accuracy study, understanding why blood glucose monitor and CGM readings might not match and the explanation of relative difference and CGM accuracy. The conversation highlights the comprehensive journey towards ensuring users can trust their CGM readings, right from day one to real-world applications. Finally, listen as they walk us through the process of bringing transparency to CGM data analysis, alongside discussing the potential challenges and future of CGM device application in pediatric hospital discharge programs, probing into the potential barriers and challenges faced by healthcare providers and patients. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Jessica R. Castle, MD and Stayce E. Beck, PhD, MPH, are employees of Dexcom. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom Continuous Glucose Monitoring System and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the Dexcom CGM do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References: 1. Castle JR, Beck SE. The Importance of Trial Design in Evaluating the Performance of Continuous Glucose Monitoring Systems: Details Matter. Journal of Diabetes Science and Technology. 2024 Feb 23 2. Clinical and Laboratory Standards Institute (CLSI). Performance Metrics for Continuous Interstitial Glucose Monitoring (CLSI Guideline POCT05). 2nd ed. Wayne, PA: CLSI; 2020. 3. Garg SK, Kipnes M, Castorino K, et al. Accuracy and safety of Dexcom G7 continuous glucose monitoring in adults with diabetes. Diabetes Technol Ther. 2022;24(6):373-380. 4. Laffel LM, Bailey TS, Christiansen MP, et al. Accuracy of a seventh-generation continuous glucose monitoring system in children and adolescents with type 1 diabetes. J Diabetes Sci Technol. 2023;17(4):962-967. 5. Polsky S, Valent AM, Isganaitis E, Castorino K, O'Malley G, Beck SE, Gao P, Laffel LM, Brown FM, Levy CJ. Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes technology & therapeutics. 2024 May 1;26(5):307-12. 6. Freckmann G, Eichenlaub M, Waldenmaier D, et al. Clinical performance evaluation of continuous glucose monitoring systems: a scoping review and recommendations for reporting. J Diabetes Sci Technol. 2023:17(6):1506-1526.