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. 2019 Mar;21(3):622-630.
doi: 10.1111/dom.13565. Epub 2018 Nov 26.

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

J Hans DeVries  1   2 , Timothy S Bailey  3 , Anuj Bhargava  4 , Gregg Gerety  5 , Janusz Gumprecht  6 , Simon Heller  7 , Wendy Lane  8 , Carol H Wysham  9 , Bernard Zinman  10 , Britta A Bak  11 , Elise Hachmann-Nielsen  11 , Athena Philis-Tsimikas  12
Affiliations

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

J Hans DeVries et al. Diabetes Obes Metab. 2019 Mar.

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.

Keywords: basal insulin; hypoglycaemia; insulin therapy; type 1 diabetes; type 2 diabetes.

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Conflict of interest statement

Author contributions

All authors confirm that they meet the International Committee of Medical Journal Editors uniform requirements for authorship. Specifically, all authors made substantial contributions to the interpretation of data for the manuscript, drafted and critically revised the manuscript, provided final approval of the version to be published and agreed to be accountable for all aspects of the manuscript. All authors had access to the final results and vouch for the fidelity of the trial to the protocol. All authors are responsible for the integrity of the work as a whole.

Figures

Figure 1
Figure 1
Linear regression analysis of the effect of day‐to‐day fasting SMBG variability (SDs) on rate of hypoglycaemia. Data were based on the full analysis set during the maintenance period. Abbreviations: CI, confidence interval; RR, rate ratio; SMBG, self‐monitored blood glucose; T1D, type 1 diabetes; T2D, type 2 diabetes
Figure 2
Figure 2
Cumulative number of hypoglycaemic episodes for patients in the low, medium or high day‐to‐day fasting SMBG variability tertile. Based on the safety analysis set. The time‐scale of Weeks 16 to 32 is included in the x‐axis, as only hypoglycaemic episodes during the maintenance periods were considered. All non‐withdrawn patients had the same duration of exposure. Abbreviations: SMBG, self‐monitored blood glucose; T1D, type 1 diabetes; T2D, type 2 diabetes
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