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
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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