Structured self-monitoring of blood glucose is associated with more appropriate therapeutic interventions than unstructured self-monitoring: A novel analysis of data from the PRISMA trial

Sergio Di Molfetta,Emanuele Bosi,Antonio Ceriello,Domenico Cucinotta,Antonio Tiengo,Marina Scavini,Carmine Piccolo,Erminio Bonizzoni,Elena Acmet,Francesco Giorgino

doi:10.1016/j.diabres.2021.109070

Abstract

AimsTo investigate the relationship between single therapeutic interventions and indicatorsofglycemic control in the PRISMA trial, a large study comparing the effects of intensive structured SMBG (ISM) vs. active control (AC) in non-insulin-treated type 2 diabetes (T2D). MethodsInformation was collected at four time points, corresponding to months 3, 6, 9, and 12 and visits 2, 3, 4, and 5, respectively. Data on therapeutic interventions, HbA1c levels and the number of hypoglycemic episodes at each visit were analyzed. ResultsIntensification of drug therapy occurred in 20.3% vs. 15.6%, and no change in 71.8% vs. 78.7% of visits for the ISM and AC groups, respectively. On the other hand, de-intensification and redistribution of drugs and/or drug dose occurred in a similar proportion of visits. Intensification of drug therapy in both groups was associated with significant reductions in HbA1c vs. the previous visit, while de-intensification of therapy led to a significant increase in HbA1c in the AC group only. Conclusions. Our data strongly support that structured SMBG has clinical value in reducing HbA1c in non-insulin-treated T2D and suggest that this clinical benefit may be mediated by more appropriate and timely changes in drug therapy.

Highlights

With the overall goal of achieving and maintaining glycemic control, self-monitoring of blood glucose (SMBG) has been proposed as a useful tool
Most scientific societies consider routine SMBG in type 2 diabetes (T2D) patients not treated with insulin of limited additional clinical impact, unless it is incorporated as a structured tool in glucose management [10]
Nine hundred seventy-four patients (478 in the intensive structured monitoring (ISM) group and 496 in the active control (AC) group) and a total of 3563 visits were included in this analysis

Summary

Introduction

With the overall goal of achieving and maintaining glycemic control, self-monitoring of blood glucose (SMBG) has been proposed as a useful tool. The Prospective Randomized Trial on Intensive SMBG Management Added Value in Non-insulin-Treated T2DM Patients (PRISMA) trial randomized > 1,000 patients with T2D treated with oral agents and/or diet to either an intensive structured monitoring (ISM) or discretionary, unstructured SMBG (active control [AC]) and assessed changes in HbA1c from baseline in either group [11]. The reduction in HbA1c at 12 months was significantly larger with ISM (-0.39%) compared to AC (-0.27%) with a between-group difference of À0.12% (95% CI, À0.210 to À0.024; p = 0.013) [12] This decrease in HbA1c is of interest considering that the enrolled patients were relatively wellcontrolled at baseline, with a median HbA1c of 7.3%. Based on the diabetes-specific quality of life and locus of control questionnaires, there was no significant difference in the quality-of-life domains between the ISM and AC groups

Results

Discussion

Conclusion