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
Open Access
- 28 August 2008
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLOS ONE
- Vol. 3 (8), e3087
- https://doi.org/10.1371/journal.pone.0003087
Abstract
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. 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. There were no differences in the 202 subjects for demographic and sociodemographic parameters and drug treatment. HbA1c (%) 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, HbA1c at 3 and 12 months and serious adverse events (SAE). One SMBG per week is as sufficient and safe as four SMBG per week to maintain HbA1c in non-insulin treated T2D close to metabolic target. The results of this study are in contrast to current international consensus guidelines. Controlled-Trials.com ISRCTN79164268Keywords
This publication has 19 references indexed in Scilit:
- Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trialBMJ, 2007
- Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of TherapyDiabetes Care, 2006
- Is Self-Monitoring of Blood Glucose Appropriate for All Type 2 Diabetic Patients?Diabetes Care, 2006
- The cost burden of diabetes mellitus: the evidence from Germany—the CoDiM StudyDiabetologia, 2006
- The effect of self monitoring of blood glucose concentrations on glycated hemoglobin levels in diabetic patients not taking insulin: A blinded, randomized trialAmerican Journal Of Medicine, 2005
- A Comparison of Observational Studies and Randomized, Controlled TrialsNew England Journal of Medicine, 2000
- Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year studyDiabetes Research and Clinical Practice, 1995
- Self-monitoring of blood glucose in overweight type 2 diabetic patientsActa Diabetologica, 1994
- The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes MellitusNew England Journal of Medicine, 1993
- Impact of Glucose Self-Monitoring on Non-lnsulin-Treated Patients With Type II Diabetes Mellitus: Randomized Controlled Trial Comparing Blood and Urine TestingDiabetes Care, 1990