AIMS: Self-monitoring of blood glucose (SMBG) is an important self-management tool for insulin-treated patients with Type 2 diabetes mellitus (T2DM). Its value in estimating glycaemic control in insulin-treated T2DM patients remains unclear. The relationship between glycated haemoglobin (HbA(1c)) and SMBG measures in T2DM patients treated withpremixed insulin lispro mixtures or basal insulin glargine was examined. METHODS: HbA(1c) and plasma equivalent glucose (PGe) data derived from SMBG profiles were pooled from five randomized clinical trials of patients with T2DM on one or more oral glucose-lowering medication +/- 0-2 insulin injections per day switching to insulin lispro mixtures (N = 317) or glargine (N = 306). Patients generated seven-point SMBG profiles three times in a 2-week period prior to each HbA(1c) measurement. Pearson's correlation coefficients (r) were calculated for PGe values and HbA(1c). Receiver-operating characteristic (ROC) curves determined the ability of sets of PGe to estimate HbA(1c) (< or > 7.0%). RESULTS:Mean +/- standard deviation age was 57.5 +/- 9.5 years, body mass index 31.3 +/- 5.6 kg/m(2), 52.5% were male and HbA(1c) overall was 7.4 +/- 1.0% at end-point. Among individual SMBG measures, r for HbA(1c) ranged from 0.34 to 0.49. For means of two or more PGe measures, r for HbA(1c) ranged from 0.51 to 0.59. Correlations were similar for either regimen. ROC curves were consistent with the correlation data. CONCLUSIONS: These data provide patients and clinicians information on the relationship between HbA(1c) and SMBG measurements in patients with T2DM, and support the value of frequent blood glucose measurements for assessing overall glycaemic control.
RCT Entities:
AIMS: Self-monitoring of blood glucose (SMBG) is an important self-management tool for insulin-treated patients with Type 2 diabetes mellitus (T2DM). Its value in estimating glycaemic control in insulin-treated T2DM patients remains unclear. The relationship between glycated haemoglobin (HbA(1c)) and SMBG measures in T2DM patients treated with premixed insulin lispro mixtures or basal insulinglargine was examined. METHODS: HbA(1c) and plasma equivalent glucose (PGe) data derived from SMBG profiles were pooled from five randomized clinical trials of patients with T2DM on one or more oral glucose-lowering medication +/- 0-2 insulin injections per day switching to insulin lispro mixtures (N = 317) or glargine (N = 306). Patients generated seven-point SMBG profiles three times in a 2-week period prior to each HbA(1c) measurement. Pearson's correlation coefficients (r) were calculated for PGe values and HbA(1c). Receiver-operating characteristic (ROC) curves determined the ability of sets of PGe to estimate HbA(1c) (< or > 7.0%). RESULTS: Mean +/- standard deviation age was 57.5 +/- 9.5 years, body mass index 31.3 +/- 5.6 kg/m(2), 52.5% were male and HbA(1c) overall was 7.4 +/- 1.0% at end-point. Among individual SMBG measures, r for HbA(1c) ranged from 0.34 to 0.49. For means of two or more PGe measures, r for HbA(1c) ranged from 0.51 to 0.59. Correlations were similar for either regimen. ROC curves were consistent with the correlation data. CONCLUSIONS: These data provide patients and clinicians information on the relationship between HbA(1c) and SMBG measurements in patients with T2DM, and support the value of frequent blood glucose measurements for assessing overall glycaemic control.
Authors: J B Møller; R V Overgaard; M C Kjellsson; N R Kristensen; S Klim; S H Ingwersen; M O Karlsson Journal: CPT Pharmacometrics Syst Pharmacol Date: 2013-10-30