Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting

Abstract

The use of different approaches for design and results presentation of studies for the clinical performance evaluation of continuous glucose monitoring (CGM) systems has long been recognized as a major challenge in comparing their results. However, a comprehensive characterization of the variability in study designs is currently unavailable. This article presents a scoping review of clinical CGM performance evaluations published between 2002 and 2022. Specifically, this review quantifies the prevalence of numerous options associated with various aspects of study design, including subject population, comparator (reference) method selection, testing procedures, and statistical accuracy evaluation. We found that there is a large variability in nearly all of those aspects and, in particular, in the characteristics of the comparator measurements. Furthermore, these characteristics as well as other crucial aspects of study design are often not reported in sufficient detail to allow an informed interpretation of study results. We therefore provide recommendations for reporting the general study design, CGM system use, comparator measurement approach, testing procedures, and data analysis/statistical performance evaluation. Additionally, this review aims to serve as a foundation for the development of a standardized CGM performance evaluation procedure, thereby supporting the goals and objectives of the Working Group on CGM established by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine.

Innovative Solution or Cause for Concern? The Use of Continuous Glucose Monitors in People Not Living with Diabetes: A Narrative Review.

“…Echoing this sentiment, the International Federation of Clinical Chemistry and Laboratory Medicine has advocated for stringent study protocols and performance criteria, as evidenced in a detailed scoping review. 81 Despite CGMs not being officially endorsed for detecting dysglycaemia, PN or shaping behavioural changes in PNLD, marketing narratives suggesting the opposite abound increasing offlabel demand for these devices. 13,42,55 Such proclamations risk being labelled 'misleading' in the face of significant evidential gaps as outlined in this review.…”

Innovative Solution or Cause for Concern? The Use of Continuous Glucose Monitors in People Not Living with Diabetes: A Narrative Review.

“…Such mandates should encapsulate precision benchmarks, manufacturer duties vis-à-vis device constraints, and responsibility for untoward events stemming from 'off-label use'. Echoing this sentiment, the International Federation of Clinical Chemistry and Laboratory Medicine has advocated for stringent study protocols and performance criteria, as evidenced in a detailed scoping review [83].…”

Head-to-Head Evaluation of Continuous Glucose Monitoring and Automated Insulin Delivery Systems: Why are They not Used More Systematically?

“…In this regard, a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has recently recommended a respective procedure. 1,2 In relatively short time intervals, the manufacturers of CGM systems bring new generations of their devices onto the market. These generations differ from each other in several aspects, like easier handling, smaller housings, longer usage time, etc.…”

“…In this regard, a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has recently recommended a respective procedure. 1,2…”

“…The study procedures differ between manufacturers and are most probably optimized for the device and algorithm tested. 1 The differences in the measurement results are given as MARD values. An MARD value <10% is regarded as sufficient for reliable diabetes therapy performance and usage in AID systems; however, the MARD is a parameter that has several limitations, in particular the dependency on the study protocol.…”