Type 1 diabetes

Evaluating the Adequacy of Coefficient of Variation and Standard Deviation as Metrics of Glucose Variability in Type 1 Diabetes Based on Data from the GOLD and SILVER Trials

Diabetes Technol TherPublished Secondary analysis of the GOLD and SILVER trials

Authors' conclusion

The SD of glucose values does not increase linearly with the MG during glucose-lowering therapy, suggesting that CV is not an optimal measure of GV. After adjusting for censored glucose values, CV remains reliable.

Study context

Population
Individuals with T1D from the GOLD and SILVER trials; glucose metrics from continuous glucose monitoring (CGM) and self-monitoring of blood glucose (SMBG)
Participants
158 individuals
Primary endpoint
Adequacy of CV and SD as metrics of glucose variability across mean glucose levels
Methodological detailsGeneralized estimating equations for SD–mean glucose relationship; restricted cubic splines; censored Gamma model for values outside CGM detection range (<2.22 and >22.2 mmol/L)
  • Generalized estimating equations for SD–mean glucose relationship; restricted cubic splines; censored Gamma model for values outside CGM detection range (<2.22 and >22.2 mmol/L)

Primary result

As reported in the abstract

SD of glucose values showed a nonlinear relationship with mean glucose during CGM and SMBG (vs linear model)
both P < 0.001
Lack of fit of the constant coefficient of variation (CV) model most distinct at high glucose levels
>12 mmol/L
During SMBG, 25% reduction in mean glucose from 12 to 9 mmol/L associated with reduction in SD of glucose values
16% (95% CI 10%-21%)

Further findings

Underestimation of treatment effect on glucose variability (SMBG to CGM transition) vs censoring-adjusted estimates

Ordinary CV underestimated treatment effect
30%
Ordinary SD underestimated treatment effect
27%

Ordinary CV vs CV adjusted for nonlinear SD–mean glucose relationship (GOLD study)

Ordinary CV underestimated treatment effect
11%

Mean glucose of included individuals

Mean glucose
10.6 (SD 1.7) mmol/L

Original publication

Evaluating the Adequacy of Coefficient of Variation and Standard Deviation as Metrics of Glucose Variability in Type 1 Diabetes Based on Data from the GOLD and SILVER Trials. Diabetes Technol Ther. Published 18 March 2025. doi:10.1089/dia.2024.0540

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