Guidelines needed for interpreting continuous glucose monitoring reports in those without diabetes

(Boston)—With the Food and Drug Administration now allowing for the over-the-counter purchase of continuous glucose monitor (CGM)—small sensors that penetrate the skin to measure glucose levels in real time, there is high consumer interest in use of these devices for health and wellness even among people without diabetes. However, a new study led by researchers from Boston University Chobanian & Avedisian School of Medicine has found there is no consensus in how clinical experts interpret CGM reports from people without this disease.

“This should be a wake-up call that research needs to be done that will inform creation of guidelines for clinical interpretation of CGM for patients without diabetes,” says corresponding author Nicole L Spartano, PhD, assistant professor of medicine at the Boston University Chobanian & Avedisian School of Medicine.

The researchers surveyed specialists who care for patients with complex diabetes (and only rarely treat individuals without diabetes) and asked them to evaluate 20 potentially challenging DexcomG6 Pro CGM reports (hemoglobin A1c [HbA1c] and fasting venous glucose levels) from individuals without diabetes. The clinicians then reported whether they would recommend follow-up and the reasoning for their decision.

Upon review of their responses, the researchers found high discordance among expert clinicians on interpreting potentially challenging CGM reports for people without diabetes highlighting the need for more research in developing normative data for people without diabetes. “Our results suggest that even clinicians with extensive CGM experience do not agree with one another on how they interpret or provide follow-up recommendations for individuals without diabetes based on CGM data.”

According to Spartano, more individuals without diabetes are becoming interested in tracking their glucose levels using CGM. “Motivations for CGM wear in these individuals are diverse and include a desire to promote healthy behaviors and avoid prediabetes/diabetes. While CGM sensors have not been approved to diagnose or predict prediabetes or diabetes, this possible application holds promise for the future.”

In the absence of specific guidelines for CGM interpretation in those without diabetes, Spartano believes physicians with continuous glucose monitoring expertise can help advise on CGM data interpretation in this new population.

These findings appear online in the Journal of Diabetes Science and Technology.

This investigation was supported by the Framingham Heart Study’s National Heart, Lung and Blood Institute contracts (N01-HC25195, HHSN268201500001I, 75N92019D00031) with additional support from NIDDK R01DK129305. Dexcom also provided continuous glucose monitoring sensors at a discounted rate for this study.

Note to editors:

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DA has received speaker fees and/or consulting fees from Abbott, Ascensia, Lilly, Mannkind, Novo, Sequel, and Xeris. He has received consulting/advisory fees from Lilly, Ascensia, and Mannkind. DWS and NLS received funding for an investigator initiated research grant from Novo Nordisk, unrelated to the current project. EEW discloses relevant conflicts of interest as an advisor, consultant, and speaker for Abbott Diabetes Care, and an advisor and consultant for Embecta. GF/IfDT received research support and/or speaker fees and/or consultancy honoraria from Abbott, Ascensia, Berlin Chemie, Boydsense, Dexcom, Glucoset, i-SENS, Lilly, Menarini, Novo Nordisk, Perfood, Pharmasens, Roche, Sinocare, Terumo, and Ypsomed. JKM is a member on the advisory boards of Abbott Diabetes Care, Becton-Dickinson/Embecta, Biomea, Eli Lilly, Medtronic, Novo Nordisk, Pharmasens, Roche Diabetes Care, Sanofi, and Viatris, received speaker honoraria from Abbott Diabetes Care, A. Menarini Diagnostics, Becton-Dickinson/Embecta, Eli Lilly, MedTrust, Novo Nordisk, Roche Diabetes Care,Sanofi, and Ypsomed, and is shareholder of decide Clinical Software GmbH and elyte Diagnostics. MCL has received funding for investigator-initiated studies from Dexcom and Abbott. MJ declares consultant and/or speaker fees and/or research support from Abbott, Air Liquide Santé International, Amgen, Asdia, Astrazeneca, Bayer, BMS, Boehringer-Ingelheim, Dexcom, Dinno Santé, Glooko, Insulet, Lifescan, Lilly, LVL médical, Medtronic, MSD, Nestle HomeCare, Novonordisk, Organon, Orkyn, Roche Diabetes, Sanofi, Tandem, Vitalaire, Voluntis, and Ypsomed. EKS has received research support from Dexcom and Tandem Diabetes for the conduct of clinical trials (at the Baltimore VA and University of Maryland). MZ reports consulting for Dexcom, Inc. RJG received research support from Novo Nordisk, Eli Lilly, Boehringer, and Dexcom, and consulting/advisory/honoraria fees from Abbott Diabetes, Astrazeneca, Bayer, Boehringer, Dexcom, Eli Lilly, Novo Nordisk, and Medtronic. TB served on advisory panels of Novo Nordisk, Sanofi, Eli Lilly, Boehringer, Medtronic, Abbott, and Indigo Diabetes. TB received honoraria for participating on the speaker’s bureaux of Eli Lilly, Novo Nordisk, Medtronic, Abbott, Sanofi, Dexcom, Aventis, Astra Zeneca, and Roche. TB’s institution received research grant support from Abbott, Medtronic, Novo Nordisk, Sanofi, Novartis, Sandoz, and Zealand Pharma, Slovenian Research and Innovation Agency, the National Institutes of Health, and the European Union. VNS’ institution receives research funding from Alexion, Novo Nordisk, Dexcom, Breakthrough T1D, and NIH. VNS has also received honoraria from Sanofi, Novo Nordisk, Dexcom, Insulet, Tandem Diabetes Care, Ascensia Diabetes Care, Embecta, Genomelink, and LumosFit for speaking, advising, or consulting work.