Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial

Aim. To analyze clinical effect of a novel approach to initiate sensor-augmented insulin pumps in type 1 diabetes mellitus (T1DM) patients through early real-time continuous glucose monitoring (RT-CGM) initiation. Methods. A 26-week pilot study with T1DM subjects randomized (1 : 1) to start RT-CGM three weeks before continuous subcutaneous insulin infusion (CGM pre-CSII) or adding RT-CGM three weeks after continuous subcutaneous insulin infusion (CGM post-CSII). Results. Twenty-two patients were enrolled with a mean age of 36.6 yr. (range 19-59 yr.) and T1DM duration of 16.8 ± 10.6 yr. Higher adherence in CGM pre-CSII patients was confirmed at study end (84.6 ± 11.1% versus 64.0 ± 25.4%; P = 0.01). The two intervention groups had similar HbA_1c reduction at study end of -0.6% (P = 0.9). Hypoglycemic event frequency reduction was observed from baseline to study end only in CGM pre-CSII group (mean difference in change, -6.3%; 95% confidence interval, -12.0 to -0.5; P = 0.04). Moreover, no severe hypoglycemia was detected among CGM pre-CSII subjects during the study follow-up (0.0 ± 0.0 events versus 0.63 ± 1.0 events; P = 0.03). CGM pre-CSII patients showed better satisfaction than CGM post-CSII patients at the end of the study (27.3 ± 9.3 versus 32.9 ± 7.2; P = 0.04). Conclusions. CGM pre-CSII is a novel approach to improve glycemic control and satisfaction in type 1 diabetes sensor-augmented pump treated patients.