ROSSO-in-praxi-international: long-term effects of self-monitoring of blood glucose on glucometabolic control in patients with type 2 diabetes mellitus not treated with insulin

Abstract

Background: Effects of lifestyle change on blood glucose levels can be monitored by self-monitoring of blood glucose (SMBG) in type 2 diabetes mellitus (T2DM) patients. We analyzed whether the SMBG-structured lifestyle intervention program ROSSO-in-praxi-international can improve glucometabolic control in the short and the long term.

Subjects and methods: One hundred twenty-four SMBG-naive ambulatory non-insulin-treated T2DM patients were randomly assigned to an SMBG group (n=63) and a control group (n=61). Both groups received a 12-week structured lifestyle guidance manual. The SMBG group additionally got a blood glucose meter with 150 test strips and was instructed to measure blood glucose regularly as well as event-driven. Glucometabolic parameters were assessed at baseline, after 12 weeks, and after 1.5 years.

Results: During the 12 weeks of intervention the SMBG group significantly improved glycated hemoglobin (HbA1c) levels (from 7.4 ± 1.6% to 6.9 ± 1.1% [P<0.001]) and weight (-0.9 ± 1.9 kg [P<0.05]), whereas HbA1c reduction (from 7.5 ± 1.0% to 7.3 ± 1.0%) and weight loss (-0.6 ± 2.4 kg) were not significant in the control group. Of the 124 patients, 122 completed the 1.5-year follow-up. In the control group HbA1c increased again, reaching baseline values (7.5 ± 0.7%). In the SMBG group HbA1c remained stable (6.9 ± 0.9% [P=0.0003 for trend]), and weight (-1.6 ± 3.0 kg vs. baseline [P=0.0003 for trend]) improved further. Eighty-seven percent of participants in the SMBG group continued to perform SMBG. Those who measured their blood glucose more than three times per week (n=24) demonstrated an overall reduction in HbA1c of 1.0% (P=0.006 vs. three times or fewer per week) after 1.5 years.

Conclusions: Integration of SMBG into basic therapy of T2DM for monitoring the effect of lifestyle changes improves glucometabolic control and has long-term effects.