Multicentre, randomised, controlled study of the impact of continuous sub-cutaneous glucose monitoring (GlucoDay®) on glycaemic control in type 1 and type 2 diabetes patients

Aim. - This randomised study was designed to investigate the impact of continuous glucose monitoring (CGM) for 48 h on glycaemic control with a 3-month follow-up in patients with type 1 (T1D) or type 2 (T2D) diabetes. Methods. - A total of 48 patients with poor glycaemic control (HbA(1c): 8-10.5%) underwent CGM for 48 h using the GlucoDay (R) C system (A. Menarini Diagnostics), after which they were randomly assigned to treatment adjustments based on either their CGM profile (CGM group) or their usual self-monitoring of blood glucose (SMBG group). HbA(1c) measurement and 48-h CGM were repeated 3 months later. Results. - Altogether, 34 patients with either T1D (n = 9) or T2D (n = 25) completed the study; seven patients chose to leave the study, and seven patients in the CGM group were excluded because their baseline CGM graphs were not interpretable. HbA(1c) levels decreased significantly in the CGM group (n = 14, -0.63 +/- 0.27%: P = 0.023), but not in the controls (n = 20, -0.28 +/- 0.21%; P=0.30). In T2D patients, the improvement associated with CGM vs SMBG was due to HbA(1c) decreases (mean: - 0.63 +/- 0.34%; P = 0.05 vs -0.31 +/- 0.29%; P = 0.18, respectively). However, HbA(1c) did not change significantly with CGM in T1D patients. Comparisons of CGM data at baseline and after 3 months showed no significant changes in glucose control, glucose variability or hypoglycaemia. No major adverse events related to the GlucoDay (R) system were reported. Conclusion. - This is the first randomised study showing that CGM improves glycaemic control in patients with T2D. (C) 2009 Elsevier Masson SAS. All rights reserved.