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

الملخص EN

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.