Abstract
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.
Highlights
Type 1 diabetes is a chronic disease caused by the interaction of genetic determinants and environmental factors resulting in an autoimmune destruction of pancreatic beta cells
Several studies have shown that closed-loop automated insulin delivery improves glucose control compared with sensor-augmented pump therapy
Our study confirms findings that automated insulin delivery improves glucose control compared with sensor-augmented pump therapy
Summary
Type 1 diabetes is a chronic disease caused by the interaction of genetic determinants and environmental factors resulting in an autoimmune destruction of pancreatic beta cells. Intensive insulin therapy aiming at good glycemic control significantly reduces microvascular and macrovascular complications.[1,2] hypoglycemia remains the major barrier to achieve glycemic targets,[3] and more than 70% of people with type 1 diabetes do not achieve glycemic targets despite advances in insulin analogues, educational programs, insulin pumps, and glucose sensors.[4]. Automated insulin delivery systems are recent technologies that automate insulin pump delivery based on glucose sensor readings and a dosing algorithm.[5] Several groups have developed dosing algorithms for automated insulin delivery systems,[6] three of which were compared with sensoraugmented pump therapy in randomized day-and-night trials in outpatient unsupervised settings with no remote monitoring. We present results of a randomized trial, comparing our automated insulin delivery system with sensoraugmented pump therapy over 12 days in outpatient, unsupervised, and free-living conditions with no remote monitoring. The system used the iPancreas platform used in other studies,[15,16,17] and a model predictive control algorithm that was less aggressive than our earlier dosing algorithm,[18,19,20] to prioritize patients’ safety over optimal system performance in our first outpatient study
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