Reviewed clinical summary · Source-linked · Educational use only

“Can a digital twin system improve time-in-range for type 1 diabetes?”

Clinical Bottom Line

A small RCT finds a digital-twin decision-support system with a simulation-assisted bolus calculator improves time in range and reduces hypoglycaemia in type 1 diabetes. PICO summary and commentary.

Summary: In a small randomised trial in type 1 diabetes, a digital-twin decision-support system with a simulation-assisted bolus calculator increased time in range and reduced hypoglycaemia compared with traditional carbohydrate-counted dosing over four weeks.

PICO Summary

ElementDetail
Population28 adults with type 1 diabetes using injections or sensor-augmented pumps; randomised, open-label, parallel-group study, Colombia.
InterventionSTUDIA digital-twin decision-support system with a simulation-assisted bolus calculator.
ComparisonTraditional carbohydrate counting for prandial insulin dosing.
OutcomeAfter 4 weeks, the simulation-assisted group had a 7% greater time in range (70–180 mg/dL; p<0.001) and a lower hypoglycaemia incidence rate (RR 0.31; p=0.022). The model’s mean absolute percentage error at 60 minutes was 19.2%, rising at longer horizons, with most simulation-versus-sensor discrepancies in no-risk or slight-risk zones.
RCT Sci Rep · 2025

Digital-twin bolus calculator in type 1 diabetes

RCT · type 1 diabetes · 4 weeks

Trial design
28 adults with type 1 diabetes Enrolled & assessed RANDOMISED 1:1 Simulation-assisted Digital-twin calculator n = 14 Control Carbohydrate counting n = 14 Change in time in range (70-180 mg/dL)
Between-group effect (95% CI)
0 (no difference) -4 12 Time in range (primary)+6.95 ✓Time below range-1.1 ✓ % points vs control · ✓ = significant
Time in range
+6.95%
95% CI 3.5 to 10.4
Hypoglycaemia
RR 0.31
95% CI 0.10 to 0.81
Time below range
-1.1%
p=0.022
Model error
19.2%
MAPE at 60 min
⬡ Bottom Line

Over four weeks, the simulation-assisted calculator raised time in range by about 7 percentage points and cut hypoglycaemia, but the trial is small, short and open-label, so it is proof-of-concept rather than practice-changing.

Expert Commentary

This is a promising proof-of-concept for a pragmatic idea, that most people with type 1 diabetes worldwide remain on injections or sensor-augmented pumps rather than full automated delivery, and that a digital-twin simulator which previews the glucose consequences of a dose could sharpen everyday bolus decisions affordably. The result is attractive on both fronts that matter, more time in range and, importantly, less hypoglycaemia rather than the usual trade-off, suggesting the tool helped users dose more precisely rather than simply more aggressively. I would weigh the findings against clear limitations. The trial is small at 28 participants and only four weeks long, it is open-label so behaviour and engagement can be influenced by knowing one has a novel tool, and the model’s predictive accuracy degraded at longer time horizons, with a roughly 19% error even at one hour, which bounds how far ahead its forecasts should be trusted. Can I use this with my patients? Not yet as a specific product, since this system is investigational, but the direction is encouraging. It supports the broader value of decision-support and simulation tools for injection-based patients, and I would watch for larger, longer trials before recommending any particular calculator in routine care.

References

Builes-Montaño CE, Lema-Perez L, Ramírez-Rincón A, et al. A digital twin-enhanced decision support system improves time-in-range in type 1 diabetes: a randomized clinical trial. Sci Rep. 2025;15(1):39738. doi:10.1038/s41598-025-23165-x

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