Multinational home use of closed-loop control is safe and effective

Stacey M. Anderson, Dan Raghinaru, Jordan E. Pinsker, Federico Boscari, Eric Renard, Bruce A. Buckingham, Revital Nimri, Francis J. Doyle, Sue A. Brown, Patrick Keith-Hynes, Marc D. Breton, Daniel Chernavvsky, Wendy C. Bevier, Paige K. Bradley, Daniela Bruttomesso, Simone Del Favero, Roberta Calore, Claudio Cobelli, Angelo Avogaro, Anne FarretJerome Place, Trang T. Ly, Satya Shanmugham, Moshe Phillip, Eyal Dassau, Isuru S. Dasanayake, Craig Kollman, John W. Lum, Roy W. Beck, Boris Kovatchev

Research output: Contribution to journalArticlepeer-review

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 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.

Original languageEnglish
Pages (from-to)1143-1150
Number of pages8
JournalDiabetes Care
Volume39
Issue number7
DOIs
StatePublished - 1 Jul 2016

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