Stacey M Anderson1, Dan Raghinaru2, Jordan E Pinsker3, Federico Boscari4, Eric Renard5, Bruce A Buckingham6, Revital Nimri7, Francis J Doyle8, Sue A Brown1, Patrick Keith-Hynes9, Marc D Breton1, Daniel Chernavvsky1, Wendy C Bevier3, Paige K Bradley3, Daniela Bruttomesso4, Simone Del Favero4, Roberta Calore4, Claudio Cobelli4, Angelo Avogaro4, Anne Farret5, Jerome Place5, Trang T Ly6, Satya Shanmugham6, Moshe Phillip7, Eyal Dassau8, Isuru S Dasanayake10, Craig Kollman2, John W Lum2, Roy W Beck11, Boris Kovatchev1. 1. University of Virginia, Charlottesville, VA. 2. Jaeb Center for Health Research, Tampa, FL. 3. William Sansum Diabetes Center, Santa Barbara, CA. 4. University of Padova, Padova, Italy. 5. Department of Endocrinology, Diabetes, and Nutrition and INSERM 1411 Clinical Investigation Center, Montpellier University Hospital, and UMR CNRS 5203/INSERM U1191, Institute of Functional Genomics, University of Montpellier, Montpellier, France. 6. Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA. 7. Jesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, and Sackler Faculty of Medicine, Tel Aviv University, Petah Tikva, Israel. 8. Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA. 9. University of Virginia, Charlottesville, VA TypeZero Technologies, LLC, Charlottesville, VA. 10. Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA. 11. Jaeb Center for Health Research, Tampa, FL rbeck@jaeb.org.
Abstract
OBJECTIVE: To evaluate the efficacy of a portable, wearable, wireless artificial pancreas system (the Diabetes Assistant [DiAs] running the Unified Safety System) on glucose control at home in overnight-only and 24/7 closed-loop control (CLC) modes in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: At six clinical centers in four countries, 30 participants 18-66 years old with type 1 diabetes (43% female, 96% non-Hispanic white, median type 1 diabetes duration 19 years, median A1C 7.3%) completed the study. The protocol included a 2-week baseline sensor-augmented pump (SAP) period followed by 2 weeks of overnight-only CLC and 2 weeks of 24/7 CLC at home. Glucose control during CLC was compared with the baseline SAP. RESULTS: Glycemic control parameters for overnight-only CLC were improved during the nighttime period compared with baseline for hypoglycemia (time <70 mg/dL, primary end point median 1.1% vs. 3.0%; P < 0.001), time in target (70-180 mg/dL: 75% vs. 61%; P < 0.001), and glucose variability (coefficient of variation: 30% vs. 36%; P < 0.001). Similar improvements for day/night combined were observed with 24/7 CLC compared with baseline: 1.7% vs. 4.1%, P < 0.001; 73% vs. 65%, P < 0.001; and 34% vs. 38%, P < 0.001, respectively. CONCLUSIONS: CLC running on a smartphone (DiAs) in the home environment was safe and effective. Overnight-only CLC reduced hypoglycemia and increased time in range overnight and increased time in range during the day; 24/7 CLC reduced hypoglycemia and increased time in range both overnight and during the day. Compared with overnight-only CLC, 24/7 CLC provided additional hypoglycemia protection during the day.
OBJECTIVE: To evaluate the efficacy of a portable, wearable, wireless artificial pancreas system (the Diabetes Assistant [DiAs] running the Unified Safety System) on glucose control at home in overnight-only and 24/7 closed-loop control (CLC) modes in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: At six clinical centers in four countries, 30 participants 18-66 years old with type 1 diabetes (43% female, 96% non-Hispanic white, median type 1 diabetes duration 19 years, median A1C 7.3%) completed the study. The protocol included a 2-week baseline sensor-augmented pump (SAP) period followed by 2 weeks of overnight-only CLC and 2 weeks of 24/7 CLC at home. Glucose control during CLC was compared with the baseline SAP. RESULTS: Glycemic control parameters for overnight-only CLC were improved during the nighttime period compared with baseline for hypoglycemia (time <70 mg/dL, primary end point median 1.1% vs. 3.0%; P < 0.001), time in target (70-180 mg/dL: 75% vs. 61%; P < 0.001), and glucose variability (coefficient of variation: 30% vs. 36%; P < 0.001). Similar improvements for day/night combined were observed with 24/7 CLC compared with baseline: 1.7% vs. 4.1%, P < 0.001; 73% vs. 65%, P < 0.001; and 34% vs. 38%, P < 0.001, respectively. CONCLUSIONS: CLC running on a smartphone (DiAs) in the home environment was safe and effective. Overnight-only CLC reduced hypoglycemia and increased time in range overnight and increased time in range during the day; 24/7 CLC reduced hypoglycemia and increased time in range both overnight and during the day. Compared with overnight-only CLC, 24/7 CLC provided additional hypoglycemia protection during the day.
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