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Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial / Othmar Moser; Max L. Eckstein; Olivia McCarthy; Rachel Deere; Jason Pitt; David M. Williams; Jennifer Hayes; Harald Sourij; Stephen C. Bain; Richard Bracken; Steve Bain

Diabetes, Obesity and Metabolism, Volume: 21, Issue: 11

Swansea University Authors: Richard, Bracken, Steve, Bain

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DOI (Published version): 10.1111/dom.13835

Abstract

AimsThe 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. This study aimed to determine the pe...

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Published in: Diabetes, Obesity and Metabolism
ISSN: 1462-8902 1463-1326
Published: 2019
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa51468
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Abstract: AimsThe 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. 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.Materials and methodsThis study comprised four randomized trial visits with alternating pre‐ and post‐exercise bolus insulin doses. Throughout the four 14‐hour inpatient phases, 19 participants received three carbohydrate‐rich meals and performed moderate‐intensity exercise. Venous blood glucose and capillary blood glucose during exercise was compared to interstitial glucose concentrations. Flash GM accuracy was assessed by median absolute relative difference (MARD) (interquartile range [IQR]) using the Bland–Altman method and Clark error grid, as well as according to guidelines for integrated CGM approvals (Class II–510(K)).ResultsThe overall MARD (IQR) during inpatient phases was 14.3% (6.9%–22.8%), during hypoglycaemia (≤3.9 mmol/L) was 31.6% (16.2%–46.8%), during euglycaemia (4.0 mmol/L − 9.9 mmol/L) was 16.0% (8.5%–24.0%) and during hyperglycaemia (≥10 mmol/L) was 9.4% (5.1%–15.7%). Overall Bland–Altman analysis showed a bias (95% LoA) of 1.26 mmol/L (−1.67 to 4.19 mmol/L). The overall MARD during acute exercise was 29.8% (17.5%–39.8%), during hypoglycaemia was 45.1% (35.2%–51.1%), during euglycaemia was 30.7% (18.7%–39.2%) and during hyperglycaemia was 16.3% (10.0%–22.8%).ConclusionFlash GM interstitial glucose readings were not sufficiently accurate within the hypoglycaemic range and during acute exercise and require confirmatory blood glucose measurements.
Issue: 11