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<p>Most individuals with type 1 diabetes (T1D) worldwide continue to be managed with multiple daily injections or sensor-augmented pumps. Decision-support systems (DSSs) have emerged as cost-effective tools to enhance treatment adherence and glucose control. We conducted a randomized, open-label, parallel-group study to evaluate STUDIA, a DSS incorporating a digital twin-enabled simulation-assisted bolus calculator. Twenty-eight participants with T1D used either the simulation-assisted calculator or traditional carbohydrate counting for prandial insulin dosing, with glucose monitored using Freestyle Libre. After four weeks, the group using the simulation-assisted calculator showed a 7% increase in time in the target glucose range (70–180&#xa0;mg/dL) compared to the control (<i>p</i> &lt; 0.001), along with a lower hypoglycemia incidence rate (RR 0.31, <i>p</i> = 0.022). Model performance yielded a mean absolute percentage error at 60&#xa0;min of 19.2 ± 6.7%, increasing at longer horizons, with most discrepancies between simulation and sensor falling into no-risk or slight-risk zones. These findings support the safety, feasibility, and potential clinical utility of the STUDIA system in people with T1D.</p>

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A digital twin-enhanced decision support system improves time-in-range in type 1 diabetes: a randomized clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月13日

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  • Carlos E. Builes-Montaño,
  • Laura Lema-Perez,
  • Alex Ramírez-Rincón,
  • John J. Zuleta-Tobón,
  • Juan C. Restrepo-Gutiérrez,
  • Hernán D. Álvarez-Zapata,
  • José García-Tirado

摘要

Most individuals with type 1 diabetes (T1D) worldwide continue to be managed with multiple daily injections or sensor-augmented pumps. Decision-support systems (DSSs) have emerged as cost-effective tools to enhance treatment adherence and glucose control. We conducted a randomized, open-label, parallel-group study to evaluate STUDIA, a DSS incorporating a digital twin-enabled simulation-assisted bolus calculator. Twenty-eight participants with T1D used either the simulation-assisted calculator or traditional carbohydrate counting for prandial insulin dosing, with glucose monitored using Freestyle Libre. After four weeks, the group using the simulation-assisted calculator showed a 7% increase in time in the target glucose range (70–180 mg/dL) compared to the control (p < 0.001), along with a lower hypoglycemia incidence rate (RR 0.31, p = 0.022). Model performance yielded a mean absolute percentage error at 60 min of 19.2 ± 6.7%, increasing at longer horizons, with most discrepancies between simulation and sensor falling into no-risk or slight-risk zones. These findings support the safety, feasibility, and potential clinical utility of the STUDIA system in people with T1D.