4.4 Review

Quality of Glycemic Control: Assessment Using Relationships Between Metrics for Safety and Efficacy

Journal

DIABETES TECHNOLOGY & THERAPEUTICS
Volume 23, Issue 10, Pages 692-704

Publisher

MARY ANN LIEBERT, INC
DOI: 10.1089/dia.2021.0115

Keywords

Quality of glycemic control; Continuous glucose monitoring; Hypoglycemia; Hyperglycemia; Statistical analysis; Graphical analysis; Hybrid closed loop; Diabetes mellitus

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This review suggests that only two metrics are sufficient for monitoring patients or comparing different forms of management interventions: one for efficacy evaluation and one for safety evaluation. By analyzing the relationships between safety and efficacy metrics, sensitivity can be improved and the need for arbitrary scoring systems can be avoided, offering the advantage of simplicity in both concept and practice.
Numerous methods have been proposed as measures of quality of glycemic control resulting in confusion regarding the best choice of metric to use by clinicians and researchers. Some methods use a single metric such as HbA1c, Mean Glucose, %Time In Range (%TIR), or Coefficient of Variation (%CV). Others use a combination of up to seven metrics, for example, Q-Score, Comprehensive Glucose Pentagon (CGP), and Personal Glycemic State (PGS). A recently proposed Composite continuous Glucose monitoring index utilizes three metrics: %TIR, Time Below Range (%TBR), and standard deviation (SD) of glucose. This review proposes that only two metrics can be sufficient when monitoring an individual patient or when comparing two or more forms of management interventions. These two metrics comprise (1) a measure of efficacy such as Mean Glucose, HbA1c, %TIR, or %Time Above Range (%TAR) and (2) a measure of safety based on risk of hypoglycemia such as %TBR, Low Blood Glucose Index (LBGI), or frequency of specified types of hypoglycemic events per patient year. By analysis of the two-dimensional graphical and statistical relationships between metrics for safety and efficacy and by testing identity versus nonidentity of these relationships, one can improve sensitivity for detection of the effects of medications and of other therapeutic interventions, avoid the need for arbitrary scoring systems for glucose values falling within versus outside the target range, and offer the advantage of conceptual and practical simplicity.

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