BACKGROUND: Composite metrics have the potential to provide more complete and clinically useful information about glycemic control than traditional individual metrics such as hemoglobin A1C, %/time/area under curve of hypoglycemia and hyperglycemia. METHODS: Using five key metrics that are derived from continuous glucose monitoring, we developed a new, multicomponent composite metric, the Comprehensive Glucose Pentagon (CGP) that demonstrates glycemic control both numerically and visually. Two of its axes are composite metrics-the intensity of hypoglycemia and intensity of hyperglycemia. This approach eliminates the use of the surrogate marker, hemoglobin A1C (A1C), and replaces it with glucose-centric metrics. RESULTS: We reanalyzed the data from two randomized control trials, the STAR 3 and ASPIRE In-Home studies using the CGP. It provided new insights into the effect of sensor-augmented pumping (SAP) in the STAR 3 trial and sensor-integrated pumping with low-glucose threshold suspend (SIP+TS) in the ASPIRE In-Home trial. CONCLUSIONS: The CGP has the potential to enable health care providers, investigators and patients to better understand the components of glycemic control and the effect of various interventions on the individual elements of that control. This can be done on a daily, weekly, or monthly basis. It also allows direct comparison of the effects on different interventions among clinical trials which is not possible using A1C alone. This new composite metric approach requires validation to determine if it provides a better predictor of long-term outcomes than A1C and/or better predictor of severe hypoglycemia than the low blood glucose index (LBGI).
RCT Entities:
BACKGROUND: Composite metrics have the potential to provide more complete and clinically useful information about glycemic control than traditional individual metrics such as hemoglobin A1C, %/time/area under curve of hypoglycemia and hyperglycemia. METHODS: Using five key metrics that are derived from continuous glucose monitoring, we developed a new, multicomponent composite metric, the Comprehensive Glucose Pentagon (CGP) that demonstrates glycemic control both numerically and visually. Two of its axes are composite metrics-the intensity of hypoglycemia and intensity of hyperglycemia. This approach eliminates the use of the surrogate marker, hemoglobin A1C (A1C), and replaces it with glucose-centric metrics. RESULTS: We reanalyzed the data from two randomized control trials, the STAR 3 and ASPIRE In-Home studies using the CGP. It provided new insights into the effect of sensor-augmented pumping (SAP) in the STAR 3 trial and sensor-integrated pumping with low-glucose threshold suspend (SIP+TS) in the ASPIRE In-Home trial. CONCLUSIONS: The CGP has the potential to enable health care providers, investigators and patients to better understand the components of glycemic control and the effect of various interventions on the individual elements of that control. This can be done on a daily, weekly, or monthly basis. It also allows direct comparison of the effects on different interventions among clinical trials which is not possible using A1C alone. This new composite metric approach requires validation to determine if it provides a better predictor of long-term outcomes than A1C and/or better predictor of severe hypoglycemia than the low blood glucose index (LBGI).
Authors: Darrell M Wilson; Dongyuan Xing; Roy W Beck; Jennifer Block; Bruce Bode; Larry A Fox; Irl Hirsch; Craig Kollman; Lori Laffel; Katrina J Ruedy; Michael Steffes; William V Tamborlane Journal: Diabetes Care Date: 2011-01-25 Impact factor: 19.112
Authors: John M Lachin; Ionut Bebu; Richard M Bergenstal; Rodica Pop-Busui; F John Service; Bernard Zinman; David M Nathan Journal: Diabetes Care Date: 2017-04-12 Impact factor: 19.112
Authors: Lalantha Leelarathna; Hood Thabit; Malgorzata E Wilinska; Lia Bally; Julia K Mader; Thomas R Pieber; Carsten Benesch; Sabine Arnolds; Terri Johnson; Lutz Heinemann; Norbert Hermanns; Mark L Evans; Roman Hovorka Journal: J Diabetes Sci Technol Date: 2019-03-31
Authors: Emily C Soriano; James M Lenhard; Jeffrey S Gonzalez; Howard Tennen; Sy-Miin Chow; Amy K Otto; Christine Perndorfer; Biing-Jiun Shen; Scott D Siegel; Jean-Philippe Laurenceau Journal: Ann Behav Med Date: 2021-03-16
Authors: Michelle Nguyen; Julia Han; Elias K Spanakis; Boris P Kovatchev; David C Klonoff Journal: Diabetes Technol Ther Date: 2020-03-04 Impact factor: 6.118
Authors: Martina Gáborová; Viera Doničová; Ivana Bačová; Mária Pallayová; Martin Bona; Igor Peregrim; Soňa Grešová; Judita Štimmelová; Barbora Dzugasová; Lenka Šalamonová Blichová; Viliam Donič Journal: Int J Environ Res Public Health Date: 2021-03-25 Impact factor: 3.390