Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study.

ABSTRACT:

Introduction

The aim of this study was to evaluate the stability and accuracy of glucose measurements determined using the metabolic heat conformation (MHC)-based non-invasive glucometer in a multicentre, self-controlled clinical trial. This device is the first to obtain a medical device registration certificate awarded by the National Medical Products Administration of China (NMPA).

Methods

The multicentre clinical study was conducted at three sites and enrolled 200 subjects whose glucose was measured with a non-invasive glucometer (the Contour Plus blood glucose monitoring system) and by venous plasma glucose (VPG) measurements, in a fasted state and at 2 and 4 h after meals.

Results

Based on both the non-invasive and VPG measurements, 93.9% (95% confidence interval

SUBMITTER: Li A 

PROVIDER: S-EPMC10203088 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature