Recommendations for Standardizing Glucose Reporting and Analysis to Optimize Clinical Decision Making in Diabetes: The Ambulatory Glucose Profile (AGP)

Abstract

Underutilization of glucose data and lack of easy and standardized glucose data collection, analysis, visualization, and guided clinical decision making are key contributors to poor glycemic control among individuals with type 1 diabetes. An expert panel of diabetes specialists, facilitated by the International Diabetes Center and sponsored by the Helmsley Charitable Trust, met in 2012 to discuss recommendations for standardization of analysis and presentation of glucose monitoring data, with the initial focus on data derived from CGM systems. The panel members were introduced to a universal software report, the Ambulatory Glucose Profile (AGP), and asked to provide feedback on its content and functionality, both as a research tool and in clinical settings. This paper provides a summary of the topics and issues discussed during the meeting and presents recommendations from the expert panel regarding the need to standardize glucose profile summary metrics and the value of a uniform glucose report to aid clinicians, researchers, and patients.

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

“…Approaches vary in complexity but usually generate similar types of information (171,173). With enough information, it becomes possible to evaluate whether the A1C level, still the gold standard, is consistent with the patient's average blood glucose (174).…”

“…The AGP provides an excellent starting point for a standardized computerized display of BGM and/or CGM data by time of day (173,178,179). To generate the AGP, an individual's blood glucose levels are measured via CGM or BGM with all glucose data pooled and analyzed as if it had been collected during a single 24-hour period.…”

“…The result is a standardized software report that can be displayed graphically. Examples of graphic AGP displays for patients with normal glucose tolerance, T1DM, and T2DM are shown in Table 9 (images 2A-C) (173,181). AGP has been proposed as a standardized method for glucose reporting and analysis (173,178,181).…”

Improving the clinical value and utility of CGM systems: issues and recommendations

“…As stated above, reporting results from CGM trials with these diverse and nonstandardised measures prevents robust comparisons between and among studies, hampers metaanalyses, and complicates interpretation of the evidence by payers and regulatory agencies [1d]. The Ambulatory Glucose Profile (AGP) has been recommended as a potential universal software report that could be adopted to standardise summary metrics among devices and manufacturers [43].…”

“…Due to differences in legal tradition, there is a higher sensitivity to these issues in Europe, particularly when data are transferred across national boundaries to largely US-based manufacturers. Guidance on cybersecurity of medical devices has recently been published [56], and the use of an international data 'safe harbour' has been proposed as a solution [57] 43]. There has been some very recent progress on this topic [58].…”