Is the closed-loop system DBLG1 able to reduce hypoglycaemic risk in case of physical activity (PA) in patients with T1D ?
We conducted a 3 months crossover trial where patients were using either a hybrid monohormonal system (CellNovo® or Kaleido® pump and Dexcom G5® sensor) using MPC-based algorithm and centralized remote monitoring, or an open loop. Patients were encouraged to practice PA, but it was recommended to announce in advance to the system, the occurrence, intensity and duration of PA.
68 patients (27 men, age 47.2±13.4 years, HbA1c 7.6±0.9%, were included, and 63 were analyzed (mITT). The median number of PA events per patient during the study was 10, median duration 60 mn, intensity light (40%), medium (42%) intense (19%). Time in range (TIR) (70-180 mg/dl) was similar with (68.2 ± 1.1%) or without (69.1 ± 1.1%) PA, as was TIR<70 mg/dl during the day (2.3 ± 0.2% v 2.4 ± 0.2%) or the night (1.2 ± 0.2% v 1.6 ± 0.2%). TIR<70 mg/dl was 1.9, 2.1, 1.9 and 2.0% following PA duration of <30mn, 30 to 60, 60 to 90 or >90 mn, and 1.6, 2.2 or 2.2% following light, medium or intense PA. TIR<70 mg/dl was 2.2, 2.3 and 1.7% with announcement <30, 30 to 60 and > 60 mn before PA and 2.3% with none.
The Diabeloop’s DBLG1 System is able to maintain good glycemic control even in the case of PA practice. Duration, intensity or PA announcement demonstrated modest impact.