Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month continuation phase

Abstract

OBJECTIVE To examine the effects of crossing over from optimized multiple daily injection (MDI) therapy to sensor-augmented pump (SAP) therapy for 6 months, and the effects of 18 months' sustained use of SAP. RESEARCH DESIGN AND METHODS The 6-month, single-crossover continuation phase of Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) provided SAP therapy to 420 subjects who completed the 1-year randomized study. The primary outcome was change in A1C in the crossover group. RESULTS A1C values were initially lower in the continuing-SAP group than in the crossover group (7.4 vs. 8.0%, P < 0.001). A1C values remained reduced in the SAP group. After 3 months on the SAP system, A1C decreased to 7.6% in the crossover group (P < 0.001); this was a significant and sustained decrease among both adults and children (P < 0.05). CONCLUSIONS Switching from optimized MDI to SAP therapy allowed for rapid and safe A1C reductions. Glycemic benefits of SAP therapy persist for at least 18 months.

Figures

Figure 1

Mean (± SEM) A1C values of 420 subjects who entered the STAR 3 continuation phase. All subjects in the continuation phase used SAP therapy. A: All subjects (MDI, n = 204; SAP, n = 216). B: Adult subjects (MDI, n = 141; SAP, n = 151). C: Pediatric subjects (MDI, n = 63; SAP, n = 65). *P < 0.001 for between-groups comparison; †P < 0.001 and ‡P < 0.05 for within-group comparison using the crossover group’s 12-month A1C value as the comparator.