Combined insulin pump therapy with real-time continuous glucose monitoring significantly improves glycemic control compared to multiple daily injection therapy in pump naïve patients with type 1 diabetes; single center pilot study experience.

OBJECTIVES This study assessed the safety and clinical effectiveness of the training protocol for initiating insulin pump therapy with real-time continuous glucose monitoring (MiniMed Paradigm REAL-Time System) in a stepwise approach on pump naive subjects with type 1 diabetes compared to a control group who remained on multiple daily injection (MDI) therapy. METHODS This was a 15-week treat-to-target pilot study of 16 adult subjects (n = 50% male, age 45.9 +/- 16 years) with type 1 diabetes (duration of diabetes 21.9 +/- 11 years) on MDI therapy with hemoglobin A1c levels at or above 7.5% at baseline. Subjects were randomized to either the study arm (using a combined insulin pump and real-time continuous glucose monitoring system) or the control arm [which continued on MDI therapy with self-monitored blood glucose (SMBG) only]. All subjects dosed insulin according to results of SMBG by finger stick and uploaded data into the CareLink data management software. RESULTS Significant improvements in glycemic control were observed from baseline in both study groups-study arm: pre-A1c 9.45 +/- 0.55 and post-A1c 7.4 +/- 0.66 (p = 0.00037); control arm: pre-A1c 8.58 +/- 1.30 and post-A1c 7.5 +/-1.01 (p = 0.04). Both arms had no incidence of severe hypoglycemia. CONCLUSION In this pilot study, the Paradigm REAL-Time System was initiated safely and effectively in type 1 diabetes patients who were pump naïve using a stepwise educational protocol.