Diabetes technology

Efficacy and safety of a tubeless open‐source hybrid automated insulin delivery use at home among adults with type 1 diabetes mellitus: Results from a 26‐week, free‐living, randomized crossover trial

Diabetes Obes MetabPublished Randomised controlled trial

Authors' conclusion

In this 26-week trial involving adults with T1DM who had never previously used AID, the tubeless AAPS use at home resulted in a significantly higher percentage of time in the target glucose range without increasing hypoglycaemia risk compared to SAP therapy.

Study context

Population
Adults with T1D aged 18–75 years, HbA1c 7%-11% (53–97 mmol/mol), never used AID, in China; mean age 33.6 ± 10.4 years, T1D duration 12.6 ± 7.0 yearscrossover
Participants
28 adults
Comparison
Tubeless open-source hybrid AID vs sensor-augmented insulin pump
Primary endpoint
Percentage of TIR (70-180 mg/dL [3.9-10.0 mmol/L])
Follow-up
Final two weeks of each treatment phase
Methodological detailsopen-label, crossover
  • Open-label
  • Crossover

Primary result

As reported in the abstract

TIR (70-180 mg/dL) · final two weeks of each phase

P < 0.01

Further findings

Time in range (TIR) with AAPS: nocturnal vs diurnal

AAPS nocturnal vs diurnal TIR (p < 0.01)
80.9 ± 13.6% vs. 73.8 ± 10.2%

Time below range

No significant differences between the two phases

Safety

No severe hypoglycaemia or serious adverse events in either phase

Original publication

Efficacy and safety of a tubeless open‐source hybrid automated insulin delivery use at home among adults with type 1 diabetes mellitus: Results from a 26‐week, free‐living, randomized crossover trial. Diabetes Obes Metab. Published 17 June 2025. doi:10.1111/dom.16505

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