Comparison between closed-loop insulin delivery system (the artificial pancreas) and sensor-augmented pump therapy: a randomised controlled crossover trial.

OBJECTIVE Several studies have shown that closed-loop automated insulin delivery (the artificial pancreas) improves glucose control compared to 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 randomised 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 to sensor-augmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (IQR 53 to 74) to 69% (60 to 73; p=0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30 to 49) to 45% (35 to 51; p=0.011). Automated insulin delivery also reduced time spent below 3.9 mmol/ and 3.3 mmol/L from 3.5% (0.8 to 5.4) to 1.6% (1.1 to 2.7; p=0.0021) and from 0.9% (0.2 to 2.1) to 0.5% (0.2 to 1.1; p=0.0122), respectively. Time spent below 2.8 mmol/L was 0.2% (0.0 to 0.6) with sensor-augmented pump therapy and 0.1% (0.0 to 0.4; p=0.155) with automated insulin delivery. CONCLUSIONS Our study confirms findings that automated insulin delivery improves glucose control compared to sensor-augmented pump therapy (Funded by National Institute of Health; ClinicalTrials.gov number, NCT02846831).