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Background <p>Smart Multiple Daily Injection (Smart MDI) systems offer a technology-enabled alternative to conventional insulin regimens, yet real-world data on their long-term glycaemic impact remain limited.</p> Methods <p>This retrospective observational study evaluated glycaemic control in 40 adults (mean age 30.7 ± 12.2 years; 55% female) using Carelink™ data. Sensor-based glucose metrics were collected during five 14-day periods: baseline (Time 0, pre-Smart MDI), and at 14 days (Time 1), 3 months (Time 2), 6 months (Time 3), and 12 months (Time 4) after Smart MDI activation. Primary outcomes included sensor glucose standard deviation (SD), coefficient of variation (CV), glucose management indicator (GMI), and time-in-range metrics (TIR, TBR, TAR).</p> Results <p>Sensor usage remained high across follow-up periods (85.7%–94.0%). Significant reductions in glucose variability were observed post-initiation: SD decreased by -10.8&#xa0;mg/dL (95% CI: -16.7 to -4.9, <i>p</i> &lt; 0.001) and CV by -3.6% (95% CI: -6.4 to -0.8, <i>p</i> = 0.012) at Time 1, with similar significant reductions maintained at subsequent timepoints. GMI remained stable (7.4–7.7%). While TIR increased and TBR decreased from baseline (50.2% and 3.5%, respectively), these trends were not statistically significant. However, TBR1 was significantly reduced at Time 3 (mean change: -1.3%, <i>p</i> = 0.011), and TAR2 at Time 1 (mean change: -5.7%, <i>p</i> = 0.034).</p> Conclusion <p>Over 12 months of follow-up, Smart MDI therapy was associated with a significant and sustained reduction in glucose variability, with favorable trends in glycaemic control. These results support the clinical value of Smart MDI systems in routine diabetes management.</p>

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Glycemic outcomes with smart MDI system in type 1 diabetes: insights from a 12-Month retrospective study

  • 期刊论文

  • 发表日期：

    2026年2月16日

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  • Miriam Longo,
  • Maria Ida Maiorino,
  • Rita Matrone,
  • Michela Di Nuzzo,
  • Michela Petrizzo,
  • Paola Caruso,
  • Maria Tomasuolo,
  • Mariangela Caputo,
  • Lorenzo Scappaticcio,
  • Giuseppe Bellastella,
  • Katherine Esposito

摘要

Background

Smart Multiple Daily Injection (Smart MDI) systems offer a technology-enabled alternative to conventional insulin regimens, yet real-world data on their long-term glycaemic impact remain limited.

Methods

This retrospective observational study evaluated glycaemic control in 40 adults (mean age 30.7 ± 12.2 years; 55% female) using Carelink™ data. Sensor-based glucose metrics were collected during five 14-day periods: baseline (Time 0, pre-Smart MDI), and at 14 days (Time 1), 3 months (Time 2), 6 months (Time 3), and 12 months (Time 4) after Smart MDI activation. Primary outcomes included sensor glucose standard deviation (SD), coefficient of variation (CV), glucose management indicator (GMI), and time-in-range metrics (TIR, TBR, TAR).

Results

Sensor usage remained high across follow-up periods (85.7%–94.0%). Significant reductions in glucose variability were observed post-initiation: SD decreased by -10.8 mg/dL (95% CI: -16.7 to -4.9, p < 0.001) and CV by -3.6% (95% CI: -6.4 to -0.8, p = 0.012) at Time 1, with similar significant reductions maintained at subsequent timepoints. GMI remained stable (7.4–7.7%). While TIR increased and TBR decreased from baseline (50.2% and 3.5%, respectively), these trends were not statistically significant. However, TBR1 was significantly reduced at Time 3 (mean change: -1.3%, p = 0.011), and TAR2 at Time 1 (mean change: -5.7%, p = 0.034).

Conclusion

Over 12 months of follow-up, Smart MDI therapy was associated with a significant and sustained reduction in glucose variability, with favorable trends in glycaemic control. These results support the clinical value of Smart MDI systems in routine diabetes management.