combined continuous glucose monitoring and subcutaneous insulin infusion versus self-monitoring of blood glucose with optimized multiple injections in type 1 diabetes: A randomized cross-over trial.

AIMS: Clinical trials exploring the effects of the combination of Continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM), as compared with Multiple Daily Injections (MDI) with traditional self-monitoring of blood glucose (SMBG), have shown relatively wide reductions of HbA1c. In those trials, the usual basal insulin for MDI is U-100 glargine; several trials have shown that degludec is associated with a substantially lower risk of nocturnal hypoglycemia in type 1 diabetes (T1DM). The aim of this cross-over trial was to investigate the efficacy of a combination of CGM and CSII versus an optimized degludec-based MDI regimen + SMBG in T1DM subjects in optimizing glucose control. MATERIAL & METHODS: The trial included 28 individuals who underwent a 4-week run-in phase, then they were randomized 1:1 to: 1) CSII+CGM followed by MDI + SMBG or 2) an MDI basal-bolus regimen followed by CSII+CGM. RESULTS: In patients randomized to the CSII+CGM --> MDI + SMBG, a significant reduction of HbA1c versus baseline was found at the end of the first phase (CSII+CGM) without significant variation on the following MDI + SMBG phase. In the arm randomized to the MDI + SMBG-->CSII+CGM sequence, a significant improvement of HbA1c was observed in the first phase (MDI + SMBG) together with a further decrease in the following CSII+CGM phase. In the comparison of the two treatments with a mixed linear model, CSII+CGM was superior to MDI + SMBG with respect to change in HbA1c (p = 0.001). CONCLUSIONS: This study suggests that CSII+CGM improves glycemic control without relevant safety issues in T1DM, in comparison with MDI + SMBG. This article is protected by copyright. All rights reserved.