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1. FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM CLASS II B TRIAL
2. FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM CLASS II B PROFESSIONAL

FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM CLASS II B PROFESSIONAL

6 In general, use of CGM systems involves a struggle with sensor accuracy during hypoglycaemia and exercise, as shown for both professional (iPro2, Enlite 2, Medtronic, USA) and personal (Minimed 640G, Medtronic Freestyle Libre 1, Abbott, USA Dexcom G4 Platinum, Dexcom, USA) CGM systems. 6 From a physiological point of view, a time lag was observed in the interval needed for glucose to diffuse from the bloodstream into the interstitium. 5Īlthough the flash GM system demonstrated good efficacy in chronic glucose monitoring settings, the accuracy of acute continuous glucose monitoring (CGM) systems was impaired during periods of high rates of change in glucose. 1 The beneficial effects of integrating flash GM technology into diabetes management include: reduced time spent in hypoglycaemia, improved glycaemic variability, 2 lower HbA1c levels 3 and increased numbers of readings per day 4 in individuals with type 1 diabetes. In July 2018 the US Food and Drug Administration (FDA) approved the Freestyle Libre flash glucose monitoring (flash GM) system (Abbott Diabetes Care Inc, USA) to monitor interstitial glucose concentration without obtaining a capillary blood sample from the fingertip for management of type 1 and type 2 diabetes in individuals 18 years of age and older. Conclusionįlash GM interstitial glucose readings were not sufficiently accurate within the hypoglycaemic range and during acute exercise and require confirmatory blood glucose measurements. Overall Bland–Altman analysis showed a bias (95% LoA) of 1.26 mmol/L (−1.67 to 4.19 mmol/L). Flash GM accuracy was assessed by median absolute relative difference (MARD) (interquartile range ) using the Bland–Altman method and Clark error grid, as well as according to guidelines for integrated CGM approvals (Class II–510(K)). Venous blood glucose and capillary blood glucose during exercise was compared to interstitial glucose concentrations. Throughout the four 14-hour inpatient phases, 19 participants received three carbohydrate-rich meals and performed moderate-intensity exercise.

FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM CLASS II B TRIAL

This study comprised four randomized trial visits with alternating pre- and post-exercise bolus insulin doses. This study aimed to determine the performance of the flash GM system during daily-life glycaemic challenges such as carbohydrate-rich meals, bolus insulin-induced glycaemic disturbances and acute physical exercise in individuals with type 1 diabetes. The efficacy of flash glucose monitoring (flash GM) systems has been demonstrated by improvements in glycaemia however, during high rates of glucose flux, the performance of continuous glucose monitoring systems was impaired, as detailed in previous studies.