Abstract
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.