Day‐to‐day fasting self‐monitored blood glucose variability is associated with risk of hypoglycaemia in insulin‐treated patients with type 1 and type 2 diabetes: A post hoc analysis of the SWITCH Trials

Abstract

Aims To investigate the association between day‐to‐day fasting self‐monitored blood glucose (SMBG) variability and risk of hypoglycaemia in type 1 (T1D) and type 2 diabetes (T2D), and to compare day‐to‐day fasting SMBG variability between treatments with insulin degludec (degludec) and insulin glargine 100 units/mL (glargine U100). Materials and Methods Data were retrieved from two double‐blind, randomized, treat‐to‐target, two‐period (32 weeks each) crossover trials of degludec vs glargine U100 in T1D (SWITCH 1, n = 501) and T2D (SWITCH 2, n = 720). Available fasting SMBGs were used to determine the standard deviation (SD) of day‐to‐day fasting SMBG variability for each patient and the treatment combination. The association between day‐to‐day fasting SMBG variability and overall symptomatic, nocturnal symptomatic and severe hypoglycaemia was analysed for the pooled population using linear regression, with fasting SMBG variability included as a three‐level factor defined by population tertiles. Finally, day‐to‐day fasting SMBG variability was compared between treatments. Results Linear regression showed that day‐to‐day fasting SMBG variability was significantly associated with overall symptomatic, nocturnal symptomatic and severe hypoglycaemia risk in T1D and T2D ( P < 0.05). Day‐to‐day fasting SMBG variability was significantly associated ( P < 0.01) with all categories of hypoglycaemia risk, with the exception of severe hypoglycaemia in T2D when analysed within tertiles. Degludec was associated with 4% lower day‐to‐day fasting SMBG variability than glargine U100 in T1D ( P = 0.0082) and with 10% lower day‐to‐day fasting SMBG variability in T2D ( P < 0.0001). Conclusions Higher day‐to‐day fasting SMBG variability is associated with an increased risk of overall symptomatic, nocturnal symptomatic and severe hypoglycaemia. Degludec has significantly lower day‐to‐day fasting SMBG variability vs glargine U100.

A practical approach to the clinical challenges in initiation of basal insulin therapy in people with type 2 diabetes

“…Glucose variability is a predictor of hypoglycaemia 50,51 . High glucose variability in patients with T2DM is associated with increased rates of overall symptomatic, nocturnal symptomatic and severe hypoglycaemia, 52 and needs to be addressed in order to mitigate the risk.…”

Age- and sex-specific profiles of temporal fasting plasma glucose variability in a population undergoing routine health screening

“…Time-dependent FPG variation, as represented by the coefficient of variation (CV), could predict mortality in subsequent all-cause, expanded or nonexpanded cardiovascular disease-related mortality independent of mean FPG, renal function, mean glycated hemoglobin A1C (HbA1C), HbA1C variation, and other risk factors in patients with type 2 diabetes, suggesting that GV may be a valuable clinical biomarker in the management of patients [ 5 , 14 ]. Day-to-day self-monitored FPG variability is found to be related to the risk of hypoglycemia in insulin-treated patients with diabetes [ 15 ].…”

Effects of Switching from Degludec to Glargine U300 in Patients with Type 1 Diabetes Having Large Day-to-Day Glycemic Variability: A Retrospective Study

“…Large day-to-day GV was de ned as SD-FBG calculated from the records of SMBG of more than 66.3mg/dL. This SD-FBG level was the criteria used for assigning patients to the high GV group in the SWITCH trial [10]. Frequent hypoglycemia was de ned as hypoglycemic events occurring more than 3 times in 30 days according to records of SMBG.…”

“…Because Deg has a longer pharmacodynamic action pro le than Gla-300, Deg tends to be more commonly used for type 1 diabetes. However, large GV and frequent hypoglycemia in type 1 diabetes can often be observed, despite the use of Deg [10].…”