Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations

Abstract

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionize the use of intensive insulin therapy in diabetes; however, progress toward that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying results, and uncertainty on how best to use CGM data to make therapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre-and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes.

How tightly controlled do fluctuations in blood glucose levels need to be to reduce the risk of developing complications in people with Type 1 diabetes?

“…As summarized above, the majority of the evidence available to date addressing the relationship between glucose variability and future diabetes complications has been based on finger-prick SMBG profiles. Non-invasive CGM devices using a sensor to measure interstitial glucose concentrations every 5 min have been available for more than 15 years, but only at the time of writing are they becoming widely reimbursed by healthcare providers and therefore more widely used [53]. Many of the measures of glucose variability summarized above can readily be calculated from glucose profiles captured from these devices, providing an amount of information that is an order of magnitude more comprehensive than SMBG.…”

Continuous Glucose Monitoring bei Schwangeren mit Typ-1-Diabetes mellitus – Vorstellung der CONCEPTT-Studie und Kommentar

“…In der S-Studie gab es 239 vs. 8 nicht geplante Besuche wegen des CGM-Systems, das ist 34-mal häufiger als bei den Kontrollen, in der P-Studie 109 vs. 3 Besuche, entsprechend 36-mal häufiger. Zu diesen grundsätzlichen Fragen der CGM-Anwendung finden sich wichtige Hinweise in der gemeinsamen Stellungnahme von ADA und EASD [5] und einem internationalen Konsenspapier [6].…”

Using Flash Continuous Glucose Monitoring in Primary Practice

“…Nevertheless, overall adoption of CGM remains at only 8–17%, even among motivated patients using insulin ( 15 – 18 ). Longstanding barriers include cost, concerns about accuracy, alarm fatigue, encumbrances of device wear, lack of standardized data reports, and uncertainty about applying the data to inform treatment decisions ( 7 , 19 , 20 ). This article revisits these obstacles in the wake of newly introduced flash CGM (FCGM) technology, a novel category of continuous data capture that can be practically implemented in primary care to add context to A1C and provide more actionable information than SMBG alone.…”