Glycaemic control is no better in diabetic patients who monitor their blood glucose than in those who do not, the open label randomized MONITOR trial has shown.
There were no significant differences in HbA1c levels or in health-related quality of life (HRQoL) among patients with non-insulin-treated type 2 diabetes (T2D) who did self-monitoring of blood glucose (SMBG) compared with those who did not at 1 year. Hypoglycaemia frequency, healthcare utilization, and insulin initiation were also comparable between groups. [JAMA Intern Med2017;doi:10.1001/jamainternmed.2017.1233]
“Even tailored feedback through messaging did not provide any advantage in glycaemic control,” said lead investigator Dr Laura Young from the University of North Carolina at Chapel Hill School of Medicine in North Carolina, US. “These findings suggest that glucose monitoring should not be a routine in patients with non-insulin-treated T2D.”
The MONITOR trial included 450 adult patients (age >30 years) with T2D (HbA1c 6.6-9.5 percent) who were not treated with insulin and randomized to SMBG once daily, SMBG once daily with enhanced feedback, or no SMBG. Neither type of self-monitoring showed advantage over no self-monitoring in terms of HbA1c reduction at 1 year (SMBG with messaging vs no SMBG, −0.09 percent; SMBG vs no SMBG, −0.05 percent; average over SMBG arms vs no SMBG, −0.07 percent).
Of note, the coprimary endpoint of HRQoL was also comparable between mental and physical estimated adjusted mean difference scores (SMBG with messaging vs no SMBG, −0.83 points; SMBG vs no SMBG, −0.05 points; average over SMBG arms vs no SMBG, −0.44 points for the physical score whereas SMBG with messaging vs no SMBG, −0.19 points; SMBG vs no SMBG, 0.19 points; average over SMBG arms vs no SMBG, 0 points for the mental score).
Previous studies assessing the efficacy of self-monitoring in diabetic patients have shown contradictory results. “Proponents of routine SMBG postulate that testing promotes better awareness of glucose levels, leading to improvements in diet and lifestyle,” said Young. “However, our findings showed that SMBG does not help at all.”
Sensitivity analysis at 6 months showed slight differences in mean HbA1c levels between the intervention and control groups (-0.33 percent; p=0.002). However, improvements in glycaemic control regressed back to baseline from 6 through 12 months.
Adverse events reported included severe hypoglycaemia (1), hospitalizations (62), and deaths (2). However, none was treatment-related.
“As the first large pragmatic US trial of SMBG, our findings provide evidence to guide patients and clinicians in making important clinical decisions about routine blood glucose monitoring,” said Young. “[Both] should engage in a dialogue regarding SMBG … it should not be routine for most patients with non-insulin-treated T2D. The findings should not also be extrapolated to patients taking insulin,” she cautioned.
In an accompanying editorial, Drs Elaine Khoong of the University of California, San Francisco, US and Joseph Ross of Yale University School of Medicine, New Haven, Connecticut, US said the study supports the “less is more” approach to glucose monitoring considering that there are no clear benefits accrued.
Source:[JAMA Intern Med2017;