Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial
| Autor: | Peter G. Jacobs, Anas El-Fathi, Laurent Legault, Marie Raffray, Ahmad Haidar, Virginie Messier, Rémi Rabasa-Lhoret, Joanna Rutkowski, Nikita Gouchie-Provencher |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Blood Glucose Pancreas Artificial Glucose control Endocrinology Diabetes and Metabolism Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Insulin delivery Randomized-controlled trial 030209 endocrinology & metabolism Artificial pancreas Pharmacology law.invention 03 medical and health sciences 0302 clinical medicine Endocrinology Insulin Infusion Systems Randomized controlled trial law Diabetes mellitus medicine Humans Hypoglycemic Agents Insulin 030212 general & internal medicine Closed-loop Cross-Over Studies business.industry Original Articles medicine.disease Crossover study Medical Laboratory Technology Diabetes Mellitus Type 1 Treatment Outcome Sensor-augmented pump therapy business Closed loop |
| Zdroj: | Diabetes Technology & Therapeutics |
| ISSN: | 1557-8593 1520-9156 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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