Bihormonal fully closed-loop glucose control in adolescents with Type 1 diabetes: an outpatient, randomized, crossover trial
Authors' conclusion
To conclude, this trial provides preliminary evidence that treatment with the bihormonal FCL system may improve glucose outcome parameters, with no safety concerns observed in adolescents with Type 1 diabetes over the short study duration.
Study context
- Population
- Adolescents with T1D aged 12–18 years15 analysed
- Participants
- 20 adolescents
- Comparison
- Bihormonal fully closed-loop system vs usual diabetes treatment
- Primary endpoint
- Time in range (TIR) (3.9-10.0 mmol/L)
Methodological detailssingle-centre, outpatient, home healthcare setting, two 2-week study periods separated by a 2-week washout
- Single-centre
- Outpatient
- Home healthcare setting
- Two 2-week study periods separated by a 2-week washout
Primary result
As reported in the abstract
P < 0.001
Further findings
Other glucose outcomes: TAR (> 10.0 mmol/L) and median blood glucose
- TAR and median blood glucose significantly improved in the fully closed-loop (FCL) period
Original publication
Bihormonal fully closed-loop glucose control in adolescents with Type 1 diabetes: an outpatient, randomized, crossover trial. Pediatr Diabetes. Published 2 September 2026. doi:10.
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