Abstract
Many people with insulin-treated diabetes continue to experience inadequate glycemic control and a high incidence of hypoglycemic events, despite improvements in therapeutic strategies. While glycated hemoglobin (HbA1c) is currently recognized as the gold-standard for assessing glycemic control, the measure reflects mean blood glucose levels over a period of time, does not inform on acute glycemic deviations, and can be unreliable in certain populations. Continuous glucose monitoring (CGM) facilitates the acquisition of blood glucose data around the clock and, importantly, predicts and/or captures acute hyper- and hypoglycemic episodes. In light of the recent publication of the Time in Range (TIR) International Consensus Group report on key CGM metrics, we performed a review of current CGM evidence for second-generation basal insulins in both people with type 1 and type 2 diabetes. The identified studies highlight the varied CGM-related metrics used to assess basal insulins, which complicate comparisons. Furthermore, all studies had small sample sizes and typically were of short duration, which may account for the lack of statistically significant between-treatment differences observed. Differences were seen in the titration approaches used and the settings in which participants were observed. These results highlight the need for further studies of second-generation basal insulin analogs that are designed to capture the standard metrics proposed by the TIR consensus group, with additional consideration given to sample size and study duration.
Highlights
Differences were seen in the titration approaches used and the settings in which participants were observed. These results highlight the need for further studies of secondgeneration basal insulin analogs that are designed to capture the standard metrics proposed by the Time in Range (TIR) consensus group, with additional consideration given to sample size and study duration
Continuous glucose monitoring (CGM) can provide a powerful tool in RCTs studying the efficacy and safety of second-generation basal insulin analogs as it can provide comprehensive data on 24-h blood glucose levels.[8]
Evidence on day-to-day and within-day glycemic variability and acute glycemic excursions may be better captured with CGM compared with HbA1c and self-monitored blood glucose (SMBG) measurements
Summary
Many people with insulin-treated diabetes continue to experience inadequate glycemic control and a high incidence of hypoglycemic events.[1,2,3,4] In both people with type 1 diabetes (T1D) and type 2 diabetes (T2D), suboptimal management of blood glucose is associated with a variety of micro- and macrovascular complications as well as hyperglycemia, diabetic ketoacidosis, and hypoglycemia.[5,6,7]. HbA1c provides a surrogate marker for average blood glucose, it may not provide a true representation of glycemic variability, including acute hyper- and hypoglycemic episodes.[8] The accuracy of HbA1c measurement can be compromised by conditions and drugs that affect red blood cell turnover, such as untreated iron deficiency, hemolysis and splenomegaly, and erythropoietin, iron, and dapsone treatment, respectively.[9] Continuous glucose monitoring (CGM), which includes both real-time or intermittently scanned CGM, provides comprehensive data on 24-h blood glucose levels and can capture acute glycemic excursions.[8]
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