Real?World Post?Market Evaluation of the EasyTouch Plus Glucose System: Random Cohort of Users

Author(s)	Mr. Rahul Rastogi, Neha Rastogi
Country	India
Abstract	Background: Post market, real world evidence (RWE) complements pre market evaluations by quantifying performance under routine conditions. Objective: To assess absolute agreement (mg/dL) between EasyTouch Plus readings and a reference value using a random selection of cohort of users Methods: Retrospective analysis of de identified user generated records. Comparisons were paired to meal time anchors as per product use; the Calibration generation and calibration logic are proprietary (IP). The publication cohort comprised users with random selction of their usage and calibration data (no time or quality filters). Primary outcomes were the proportions of comparisons within ±15 and ±20 mg/dL of the anchor reference; secondary outcomes were mean absolute difference (MAD), median absolute difference (MdAD), bias, SD, and Bland–Altman limits of agreement (LoA). Bland–Altman and Deming (?=1) analyses were performed on the cohort pairs.
Keywords	Glucometer, Blood Glucose, Touch Based Gluucometer
Field	Engineering
Published In	Volume 6, Issue 4, July-August 2025
Published On	2025-08-24
DOI	https://doi.org/10.63363/aijfr.2025.v06i04.1141
Short DOI	https://doi.org/g9zzbc

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