Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial

Objective: Several studies have shown that closed-loop automated insulin delivery (the artificial pancreas) improves glucose control compared with sensor-augmented pump therapy. We aimed to confirm these findings using our automated insulin delivery system based on the iPancreas platform. Research Design and Methods: We conducted a two-center, randomized crossover trial comparing automated insulin delivery with sensor-augmented pump therapy in 36 adults with type 1 diabetes. Each intervention lasted 12 days in outpatient free-living conditions with no remote monitoring. The automated insulin delivery system used a model predictive control algorithm that was a less aggressive version of our earlier dosing algorithm to emphasize safety. The primary outcome was time in the range 3.9–10.0 mmol/L. Results: The automated insulin delivery system was operational 90.2% of the time. Compared with the sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9–10.0 mmol/L) from 61% (interquartile range 53–74) to 69% (60–73; P = 0.006) and increased time in tight target range (3.9–7.8 mmol/L) from 37% (30–49) to 45% (35–51; P = 0.011). Automated insulin delivery also reduced time spent below 3.9 and 3.3 mmol/L from 3.5% (0.8–5.4) to 1.6% (1.1–2.7; P = 0.0021) and from 0.9% (0.2–2.1) to 0.5% (0.2–1.1; P = 0.0122), respectively. Time spent below 2.8 mmol/L was 0.2% (0.0–0.6) with sensor-augmented pump therapy and 0.1% (0.0–0.4; P = 0.155) with automated insulin delivery. Conclusions: Our study confirms findings that automated insulin delivery improves glucose control compared with sensor-augmented pump therapy. ClinicalTrials.gov no. NCT02846831.