TY - JOUR
T1 - Multinational home use of closed-loop control is safe and effective
AU - Anderson, Stacey M.
AU - Raghinaru, Dan
AU - Pinsker, Jordan E.
AU - Boscari, Federico
AU - Renard, Eric
AU - Buckingham, Bruce A.
AU - Nimri, Revital
AU - Doyle, Francis J.
AU - Brown, Sue A.
AU - Keith-Hynes, Patrick
AU - Breton, Marc D.
AU - Chernavvsky, Daniel
AU - Bevier, Wendy C.
AU - Bradley, Paige K.
AU - Bruttomesso, Daniela
AU - Del Favero, Simone
AU - Calore, Roberta
AU - Cobelli, Claudio
AU - Avogaro, Angelo
AU - Farret, Anne
AU - Place, Jerome
AU - Ly, Trang T.
AU - Shanmugham, Satya
AU - Phillip, Moshe
AU - Dassau, Eyal
AU - Dasanayake, Isuru S.
AU - Kollman, Craig
AU - Lum, John W.
AU - Beck, Roy W.
AU - Kovatchev, Boris
N1 - Publisher Copyright:
© 2016 by the American Diabetes Association.
PY - 2016/7/1
Y1 - 2016/7/1
N2 - 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 overnightonly 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 CLCwere 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 environmentwas 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.
AB - 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 overnightonly 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 CLCwere 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 environmentwas 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.
UR - http://www.scopus.com/inward/record.url?scp=84992238301&partnerID=8YFLogxK
U2 - 10.2337/dc15-2468
DO - 10.2337/dc15-2468
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C2 - 27208316
AN - SCOPUS:84992238301
SN - 0149-5992
VL - 39
SP - 1143
EP - 1150
JO - Diabetes Care
JF - Diabetes Care
IS - 7
ER -
