1/31/2024 0 Comments Cgm findingsAvailability of better data regarding these research questions may facilitate regulatory evaluation of new therapies and may support constructive changes in guidelines for management. Continuous measurement of glucose eliminates this problem and additionally reveals between-day differences as well as within-day patterns of glycemia. Because few people eat their meals at the same time each day, the results of these standardized profiles may bear little relation to a patient’s actual day-to-day patterns. A particular problem concerns the use of 6-, 7-, or 8-point self-measured glucose profiles to assess preprandial, postprandial, and overnight patterns and the frequency of events. Documentation of unrecognized events in trials depends on the frequency and timing of glucose testing, which may differ between randomized groups, introducing bias in assessing the true incidence and rate of events. Up until now, comparisons of hypoglycemic risks in clinical trials have been limited by the fact that many events are unrecognized and therefore not reported by the patient. Differences between individuals within ethnic groups are also apparent ( 9), and CGM findings may be used to establish an individual’s unique HbA 1c target based on that person’s HbA 1c–to–mean glucose relationship.Īnother exciting possibility is that CGM can be used as an outcome measure in clinical trials. The hypothesis that Caucasian and African American populations may differ in the relationship of HbA 1c to mean glucose levels has been supported by data collected by CGM ( 8). One research question that is relevant to individualization of therapy has already been partly answered. Fortunately, because CGM can be both a clinical guide and a unique tool for clinical investigation, research questions that were previously out of reach can now be studied. For which patients should CGM be prescribed and reimbursed? How can those who use CGM learn to do so most effectively? What glycemic goals are attainable for various kinds of patients? How do we determine the levels and frequencies of hypoglycemia that are safe and tolerable for individual patients? These unanswered questions highlight limitations of knowledge about the devices themselves and also about how daily glycemic patterns contribute to the complications of diabetes and the risks associated with treatment. Notwithstanding their strengths, these statements do not address other important questions. Several related studies and narratives are also included in this issue of Diabetes Care with a special emphasis on CGM and hypoglycemia ( 4– 7). Although there is some overlap of topics and opinions between these articles, each one emphasizes different aspects. In the other, an international group of experts reviews current evidence on how best to use CGM information for improving patient care and research, including a discussion of the need for standardizing the format by which data are reported using different CGM systems ( 3). A strong consensus reached by these groups provides an important step forward from previously differing approaches to these issues. In one, experts representing various groups with a strong interest in T1D define measures of glycemic control other than HbA 1c, including categories of hypoglycemia and proportions of time in glucose target ranges during CGM, and also consider how best to use patient-reported outcomes in T1D ( 2). In addition, we present two other Consensus Reports. It also addresses some practical issues regarding instruction of potential users of these devices and concerns about safety. This statement reviews clinical evidence regarding use of CGM and describes the properties and limitations of available CGM systems. The editorial committee of Diabetes Care is proud to present a Scientific Statement developed jointly by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes titled “Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations” ( 1). Several articles in this issue of Diabetes Care summarize recent progress in CGM measurements and their interpretation. Notably, such profiles provide the opportunity to develop measures of glycemic control that provide clinically helpful information beyond that provided by an HbA 1c value and periodic self-testing of capillary glucose. Obtaining profiles of glucose levels continuously, day and night, is likely to bring new scientific insights and greater ability to individualize treatments for patients with both type 1 diabetes (T1D) and type 2 diabetes (T2D). We believe such a moment is now upon us, brought by development of reliable devices for continuous glucose monitoring (CGM). Periodically, a new idea, method, or tool leads to a turning point in the management of diabetes.
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