Because of the recent momentum embracing the value of CGM technology in the management of diabetes, some health companies have been exploring its use for their nondiabetic customers to navigate glucose spikes and modulate eating behaviors, despite little, if any, research supporting this practice. Researchers from the University College London Centre of Obesity Research published their findings about using this technology in people without diabetes in Diabetic Medicine.

Dr. Adrian Brown, coauthor of this study and affiliated with University College London Centre of Obesity Research, and colleagues explored evidence to determine whether CGMs were effective in measuring blood glucose levels and assessing variability of levels, including elevated blood glucose values, in patients without diabetes and if this technology could be a potentially “innovative solution to influence eating behaviors or if it might be a cause for concern.” They evaluated available research on the ability of CGM to detect abnormal glucose, behavioral changes observed with its use, as well as metabolic health improvements.

According to Dr. Brown, “While there are some benefits to personalized health programs offered by commercial providers, including getting people to think about what and how much they’re eating, the fact is that we don’t have the same health outcome data for CGM use in people not living with diabetes,” adding, “This review unpicks the idea of ‘abnormal glucose,’ the accuracy of CGM data, and the effect on behavioral change when CGMs are used by people without diabetes. At the moment, there are big questions about how much guidance these health companies are giving customers to help them interpret their glucose data and what scientific evidence this guidance is based on. This can leave the customer to interpret what the variations in their blood glucose mean, posing a risk that they misinterpret the data and avoid certain foods unnecessarily.”

John Pemberton, a diabetes dietitian from Birmingham Children’s Hospital and coauthor of the study, stated, “CGMs with an accuracy within 20% of actual blood glucose levels, at least 95% of the time, represent current market leading performance, and are extremely helpful for people with diabetes to make daily treatment decisions.” He added, “However, the regulations for CGMs for people living with diabetes are ambiguous both nationally and internationally, making it difficult to know if available CGMs meet this level of accuracy. This is why the IFCC [International Federation of Clinical Chemistry] CGM group are pushing for an international standard. For individuals not living with diabetes, the situation is even more uncertain. We have little robust information on whether CGMs achieve the required accuracy in this population.” Mr. Pemberton is a member of the IFCC and Laboratory Medicine Working Group on CGM.

The authors concluded, “In the face of these research gaps, we urge for the commercial claims suggesting the utility of the device in PNLD [people not living with diabetes] to be labelled as misleading. We argue that there is a regulatory inadequacy that fuels ‘off-label’ CGM distribution and calls for the strengthening of postmarket clinical follow-up oversight for CGMs. We hope this will help to avert the continued misinformation risk to PNLD and ‘off-label’ exacerbation of health disparities.”

Importantly, while other uses of CGM are explored, the use of CGM in patients with diabetes is strongly reinforced in the 2023 American Diabetes Association Standards of Care, which recommends the use of real-time CGM in all adults with type 2 diabetes on basal insulin.

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