Value and Utility of Structured Self-Monitoring of Blood Glucose in Real World Clinical Practice: Findings from a Multinational Observational Study

Abstract

The Structured Testing Program (STeP) study, a cluster-randomized, controlled trial, showed that a structured self-monitoring of blood glucose (SMBG)-based intervention improves clinical outcomes. It is important to determine whether this intervention can be adapted for use in general medical practice. This study examined the feasibility and effects of a modified version of the STeP intervention on clinical and attitudinal outcomes in real world clinical settings. In this 3-month, observational, multinational study, 375 type 1 and type 2 diabetes patients in 11 countries were asked to generate a blood glucose (bG) profile once per month for 3 consecutive months, using a paper-based bG analysis tool (Accu-Chek® 360° View® bG analysis system, Roche Diagnostics, Mannheim, Germany). Measurements were to be performed before and 2 h after main meals and before bedtime on 3 consecutive days. End points included change from baseline in glycated hemoglobin (HbA1c) and other parameters of diabetes complications. Patient and physician attitudes toward use of the structured testing form were also assessed. Reductions in mean (SD) HbA1c from baseline were significant, from 9.2% (1.6%) to 8.0% (1.4%) (Δ -1.2% [1.6%], P<0.001). Reductions in mean (SD) average bG from baseline were significant, from 189.5 mg/dL (55.5 mg/dL) to 153 mg/dL (39.6 mg/dL) (Δ-36.4 mg/dL [52.5 mg/dL], P<0.001). Significant (P<0.001) improvements in body mass index, lipids, and blood pressure were also observed. Patients and physicians were generally positive about the utility of the structured testing form. Use of the structured SMBG intervention is practical in real world clinical settings and is associated with improved diabetes management.