The growing use of continuous glucose monitors in people without diabetes: an evidence‐free zone

Abstract

The use of continuous glucose monitors (CGMs) is growing among people without diabetes, and is being encouraged by CGM manufacturers and personalised nutrition companies alike. This article critically discusses the issues that may arise from this new trend, including pathologising normal post‐prandial glucose excursions, the unnecessary avoidance of healthful foods and the risk of a glucocentric approach to nutrition which could inadvertently increase the risk of cardiometabolic diseases a person is trying to avoid. The theoretical benefits of CGMs in people without diabetes will be discussed, and recommendations for the evidence needed to help realise their potential will be made. Copyright © 2023 John Wiley & Sons.

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

“…86 Particularly concerning is the lack of studies inquiring into the unanticipated psychological ramifications of CGM use in non-medical settings. 13 Excessive glucose monitoring might unintentionally create maladaptive dietary changes in PNLD (e.g., exclusion of health food to avoid glucose excursion), especially when untrained users grapple with spurious hypo-or hyperglycaemic readings stemming from CGM inaccuracies. While similar calorie and fitness monitoring has been linked to the development of anxiety, compulsive behaviours, or disordered eating patterns, the consequences of CGM data on exacerbating these issues has not been extensively explored.…”

“…85 Studies measuring the effect of CGMs on the quality of life, disordered eating and other potential non-clinical factors would provide guidance for PNLD should they want to use the device. 13 Finally, by presenting the findings in a narrative format this review aims to allow for a broad perspective on the developments in the field. Serving as the first formal attempt to highlight the evidential gap for what appears to be a rapidly expanding off-label use of a medical device, we suggest that the current regulatory frameworks are inadequate to protect wellbeing of both people living with and without diabetes.…”

“…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. Addressing these regulatory gaps remains imperative to avert the continued misinformation risk to PNLD, potentially leading to deleterious health outcomes.…”

“…A case in point is the Freestyle Libre 2 Flash, CE-certified for ISF glucose measurement in PLWD yet acquired by med-tech companies for providing dietary guidance in PNLD. 13,42,55,77 This presents a regulatory puzzle, amplifying concerns over CGM distribution controls and the latent risks for PNLD utilising devices outside of intended purposes. While the EU MDR 2017/745 outlines the regulations for distributors and post-market observation, it remains reticent on the consequences of unsanctioned medical device distribution.…”

A method for evaluating the risks of glucose dysregulation in daily life by continuous measurement of glucose excursions under reduced glycemic load: a pilot study

“…Notably, the criteria for evaluating the extent of dysregulation of glucose metabolism in individuals without diabetes mellitus remain unclear due to insufficient data for such healthy individuals with potential metabolic risks. Some attempts have been made referring to the diagnostic criteria for diabetes mellitus, which potentially leads CGM users to suboptimal behaviors, including unnecessary dietary restriction with a risk of undernutrition (Guess, 2023).…”