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

Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Perkins BA, Welsh JB, Willi SM, Wood MA, STAR 3 Study Gro - Diabetes Care (2011)

Bottom Line: A1C values remained reduced in the SAP group.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.

View Article: PubMed Central - PubMed

Affiliation: International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, USA. richard.bergenstal@parknicollet.com

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.

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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.
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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.

Mentions: A total of 420 of 443 subjects completed the study phase and participated in the continuation phase; 204 of 216 SAP subjects (94%) and 190 of 204 crossover subjects (93%) completed both phases of the study. In the SAP group, the improvement in A1C levels seen during the study phase was maintained during the continuation phase (Fig. 1A). Overall mean (± SEM) A1C levels for these subjects at 15 and 18 months were not significantly different than the 12-month value of 7.4 ± 0.1% (P > 0.05). In contrast, patients in the crossover group realized a significant decrease in A1C from 12 months (8.0 ± 0.1%) to 15 or 18 months (7.6 ± 0.1%, P < 0.001; Fig. 1A). The significant decrease in A1C values in the crossover group was seen in adult (n = 141; Fig. 1B) and pediatric (n = 63; Fig. 1C) subjects.


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

Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Perkins BA, Welsh JB, Willi SM, Wood MA, STAR 3 Study Gro - Diabetes Care (2011)

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.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3198292&req=5

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.
Mentions: A total of 420 of 443 subjects completed the study phase and participated in the continuation phase; 204 of 216 SAP subjects (94%) and 190 of 204 crossover subjects (93%) completed both phases of the study. In the SAP group, the improvement in A1C levels seen during the study phase was maintained during the continuation phase (Fig. 1A). Overall mean (± SEM) A1C levels for these subjects at 15 and 18 months were not significantly different than the 12-month value of 7.4 ± 0.1% (P > 0.05). In contrast, patients in the crossover group realized a significant decrease in A1C from 12 months (8.0 ± 0.1%) to 15 or 18 months (7.6 ± 0.1%, P < 0.001; Fig. 1A). The significant decrease in A1C values in the crossover group was seen in adult (n = 141; Fig. 1B) and pediatric (n = 63; Fig. 1C) subjects.

Bottom Line: A1C values remained reduced in the SAP group.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.

View Article: PubMed Central - PubMed

Affiliation: International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, USA. richard.bergenstal@parknicollet.com

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.

Show MeSH
Related in: MedlinePlus