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Randomized Controlled Trial
. 2008 Aug 28;3(8):e3087.
doi: 10.1371/journal.pone.0003087.

Effect of the frequency of self-monitoring blood glucose in patients with type 2 diabetes treated with oral antidiabetic drugs-a multi-centre, randomized controlled trial

Werner A Scherbaum  1 , Christian Ohmann, Heinz-Harald Abholz, Nico Dragano, Mark Lankisch
Affiliations
Randomized Controlled Trial

Effect of the frequency of self-monitoring blood glucose in patients with type 2 diabetes treated with oral antidiabetic drugs-a multi-centre, randomized controlled trial

Werner A Scherbaum et al. PLoS One. .

Abstract

Objective: Recommendations on the frequency of self-monitoring of blood glucose (SMBG) vary widely among physicians treating patients with type 2 diabetes (T2D). Aim of this study was to investigate two testing regimen of SMBG in patients with stable metabolic control.

Research design and methods: Patients with T2D treated with oral antidiabetic drugs were randomized to two groups: either one SMBG (low) or four SMBG (high) per week. Subjects were followed up after 3, 6 and 12 months. Primary outcome parameter was the change in HbA1c between baseline and 6 months. Primary outcome criterion was tested by a one-sided t- test for non- inferiority. Secondary outcome parameters were safety, compliance and HbA1c at 3 and 12 months.

Results: There were no differences in the 202 subjects for demographic and sociodemographic parameters and drug treatment. HbA(1)c (%) at baseline was similar in both groups (7.2+/-1.4 vs. 7.2+/-1.0). Non- inferiority was demonstrated for the low group (p = 0.0022) with a difference from baseline to 6 months of 0.24 in the low and of 0.16 in the high group. Compliance with the testing regimen was 82-90% in both groups. There were no statistical significant differences for compliance, HbA(1)c at 3 and 12 months and serious adverse events (SAE).

Conclusion: One SMBG per week is as sufficient and safe as four SMBG per week to maintain HbA(1)c in non-insulin treated T2D close to metabolic target. The results of this study are in contrast to current international consensus guidelines.

Trial registration: Controlled-Trials.com ISRCTN79164268.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Flow of participants in the trial (according to CONSORT statement).
* with respect to primary outcome criterion HbA1c.
See this image and copyright information in PMC

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