A New Era in Continuous Glucose Monitoring: Food and Drug Administration Creates a New Category of Factory-Calibrated Nonadjunctive, Interoperable Class II Medical Devices

GargSatish, K; Kaan, AkturkH.

doi:10.1089/dia.2018.0142

Cited by 32 publications

(26 citation statements)

References 55 publications

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“…Data were analysed for normal distribution using Shapiro–Wilk testing to assess whether median or mean absolute relative difference must be shown. Flash GM sensor performance was analysed using median absolute relative difference (MARD) (IQR), the Bland–Altman method and the Clarke error grid, as well as according to guidelines for integrated CGM approvals (Class II–510(K)) . The Clarke error grid is divided into zones to evaluate the risk caused by inaccuracy of measurement.…”

Section: Methodsmentioning

confidence: 99%

“…Flash GM sensor performance was analysed using median absolute relative difference (MARD) (IQR), the Bland-Altman method and the Clarke error grid, as well as according to guidelines for integrated CGM approvals (Class II-510(K)). 16 The Clarke error grid is divided into zones to evaluate the risk caused by inaccuracy of measurement. Values were stratified for glycaemic ranges, defined as hypoglycaemia level 1 (≤3.9 mmol/L), euglycaemia (4.0-9.9 mmol/L) and hyperglycaemia (≥10 mmol/L).…”

Section: Statistical Analysesmentioning

confidence: 99%

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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

Moser

Eckstein

McCarthy

et al. 2019

Diabetes Obesity Metabolism

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Aims 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. 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 methods This 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)). Results The 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%). Conclusion Flash GM interstitial glucose readings were not sufficiently accurate within the hypoglycaemic range and during acute exercise and require confirmatory blood glucose measurements.

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Section: Methodsmentioning

confidence: 99%

Section: Statistical Analysesmentioning

confidence: 99%

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

Moser

Eckstein

McCarthy

et al. 2019

Diabetes Obesity Metabolism

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show abstract

“…The development of continuous glucose monitors has been rapid and now most monitors have similar accuracy to blood glucose meters (mean absolute relative difference <10%). 9 Factorycalibrated interoperable continuous glucose monitors, which do not require any further calibration, could be integrated with any insulin pump for automated insulin delivery or closed-loop systems, 10 which are likely to be more acceptable for patients and providers and could improve efficacy and safety. The development of interoperable continuous glucose monitors might represent a new pathway for faster regulatory approval of future systems.…”

Section: Closed-loop Insulin Delivery Systems For Patients With Diabetesmentioning

confidence: 99%

Closed-loop insulin delivery systems for patients with diabetes

Garg

Shah

2019

The Lancet Digital Health

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“…1 Specifically, DTT published the full report on the first iCGM (Dexcom G6) in the June issue of 2018, 2 which highlighted the detailed data for adults and adolescents in the pivotal study that led to approval of the G6 by the FDA as the first iCGM. 3,4 This is the first standalone (factory-calibrated) Real-Time Continuous Glucose Monitor (CGM) approved by the FDA. While allowing a faster approval process (510K instead of PMA) in the future for iCGM, the FDA recommended stricter guidelines.…”

mentioning

confidence: 99%

“…While allowing a faster approval process (510K instead of PMA) in the future for iCGM, the FDA recommended stricter guidelines. 3 In addition, use of acetaminophen does not interfere with the real-time glucose data. 3 The October issue of the journal reported STAT study results, emphasizing the proper use of inhaled insulin (Afrezza, Mannkind Corporation, Westlake, CA).…”

mentioning

confidence: 99%