CONTEXT: Closed-loop control (CLC) relies on an individual's open-loop insulin pump settings to initialize the system. Optimizing open-loop settings before using CLC usually requires significant time and effort. OBJECTIVE: The objective was to investigate the effects of a one-time algorithmic adjustment of basal rate and insulin to carbohydrate ratio open-loop settings on the performance of CLC. DESIGN: This study reports a multicenter, outpatient, randomized, crossover clinical trial. PATIENTS: Thirty-seven adults with type 1 diabetes were enrolled at three clinical sites. INTERVENTIONS: Each subject's insulin pump settings were subject to a one-time algorithmic adjustment based on 1 week of open-loop (i.e., home care) data collection. Subjects then underwent two 27-hour periods of CLC in random order with either unchanged (control) or algorithmic adjusted basal rate and carbohydrate ratio settings (adjusted) used to initialize the zone-model predictive control artificial pancreas controller. Subject's followed their usual meal-plan and had an unannounced exercise session. MAIN OUTCOMES AND MEASURES: Time in the glucose range was 80-140 mg/dL, compared between both arms. RESULTS: Thirty-two subjects completed the protocol. Median time in CLC was 25.3 hours. The median time in the 80-140 mg/dl range was similar in both groups (39.7% control, 44.2% adjusted). Subjects in both arms of CLC showed minimal time spent less than 70 mg/dl (median 1.34% and 1.37%, respectively). There were no significant differences more than 140 mg/dL. CONCLUSIONS: A one-time algorithmic adjustment of open-loop settings did not alter glucose control in a relatively short duration outpatient closed-loop study. The CLC system proved very robust and adaptable, with minimal (<2%) time spent in the hypoglycemic range in either arm.
RCT Entities:
CONTEXT: Closed-loop control (CLC) relies on an individual's open-loop insulin pump settings to initialize the system. Optimizing open-loop settings before using CLC usually requires significant time and effort. OBJECTIVE: The objective was to investigate the effects of a one-time algorithmic adjustment of basal rate and insulin to carbohydrate ratio open-loop settings on the performance of CLC. DESIGN: This study reports a multicenter, outpatient, randomized, crossover clinical trial. PATIENTS: Thirty-seven adults with type 1 diabetes were enrolled at three clinical sites. INTERVENTIONS: Each subject's insulin pump settings were subject to a one-time algorithmic adjustment based on 1 week of open-loop (i.e., home care) data collection. Subjects then underwent two 27-hour periods of CLC in random order with either unchanged (control) or algorithmic adjusted basal rate and carbohydrate ratio settings (adjusted) used to initialize the zone-model predictive control artificial pancreas controller. Subject's followed their usual meal-plan and had an unannounced exercise session. MAIN OUTCOMES AND MEASURES: Time in the glucose range was 80-140 mg/dL, compared between both arms. RESULTS: Thirty-two subjects completed the protocol. Median time in CLC was 25.3 hours. The median time in the 80-140 mg/dl range was similar in both groups (39.7% control, 44.2% adjusted). Subjects in both arms of CLC showed minimal time spent less than 70 mg/dl (median 1.34% and 1.37%, respectively). There were no significant differences more than 140 mg/dL. CONCLUSIONS: A one-time algorithmic adjustment of open-loop settings did not alter glucose control in a relatively short duration outpatient closed-loop study. The CLC system proved very robust and adaptable, with minimal (<2%) time spent in the hypoglycemic range in either arm.
Authors: Fraser Cameron; Günter Niemeyer; Darrell M Wilson; B Wayne Bequette; Kari S Benassi; Paula Clinton; Bruce A Buckingham Journal: Diabetes Technol Ther Date: 2014-09-26 Impact factor: 6.118
Authors: Howard Zisser; Eric Renard; Boris Kovatchev; Claudio Cobelli; Angelo Avogaro; Revital Nimri; Lalo Magni; Bruce A Buckingham; H Peter Chase; Francis J Doyle; John Lum; Peter Calhoun; Craig Kollman; Eyal Dassau; Anne Farret; Jerome Place; Marc Breton; Stacey M Anderson; Chiara Dalla Man; Simone Del Favero; Daniela Bruttomesso; Alessio Filippi; Rachele Scotton; Moshe Phillip; Eran Atlas; Ido Muller; Shahar Miller; Chiara Toffanin; Davide Martino Raimondo; Giuseppe De Nicolao; Roy W Beck Journal: Diabetes Technol Ther Date: 2014-07-08 Impact factor: 6.118
Authors: Hood Thabit; Alexandra Lubina-Solomon; Marietta Stadler; Lalantha Leelarathna; Emma Walkinshaw; Andrew Pernet; Janet M Allen; Ahmed Iqbal; Pratik Choudhary; Kavita Kumareswaran; Marianna Nodale; Chloe Nisbet; Malgorzata E Wilinska; Katharine D Barnard; David B Dunger; Simon R Heller; Stephanie A Amiel; Mark L Evans; Roman Hovorka Journal: Lancet Diabetes Endocrinol Date: 2014-06-16 Impact factor: 32.069
Authors: Eyal Dassau; Howard Zisser; Rebecca A Harvey; Matthew W Percival; Benyamin Grosman; Wendy Bevier; Eran Atlas; Shahar Miller; Revital Nimri; Lois Jovanovic; Francis J Doyle Journal: Diabetes Care Date: 2012-11-27 Impact factor: 19.112
Authors: Sheri R Colberg; Wendy C Bevier; Jordan E Pinsker; Joon Bok Lee; Brigid Ehrlich; Eyal Dassau; Francis J Doyle; Kong Y Chen; David Kerr Journal: J Diabetes Sci Technol Date: 2016-06-28
Authors: Jordan E Pinsker; Alejandro J Laguna Sanz; Joon Bok Lee; Mei Mei Church; Camille Andre; Laura E Lindsey; Francis J Doyle; Eyal Dassau Journal: Diabetes Technol Ther Date: 2018-07 Impact factor: 6.118
Authors: Gregory P Forlenza; Sunil Deshpande; Trang T Ly; Daniel P Howsmon; Faye Cameron; Nihat Baysal; Eric Mauritzen; Tatiana Marcal; Lindsey Towers; B Wayne Bequette; Lauren M Huyett; Jordan E Pinsker; Ravi Gondhalekar; Francis J Doyle; David M Maahs; Bruce A Buckingham; Eyal Dassau Journal: Diabetes Care Date: 2017-06-05 Impact factor: 19.112
Authors: Jordan E Pinsker; Joon Bok Lee; Eyal Dassau; Dale E Seborg; Paige K Bradley; Ravi Gondhalekar; Wendy C Bevier; Lauren Huyett; Howard C Zisser; Francis J Doyle Journal: Diabetes Care Date: 2016-06-11 Impact factor: 19.112
Authors: Joon Bok Lee; Eyal Dassau; Ravi Gondhalekar; Dale E Seborg; Jordan E Pinsker; Francis J Doyle Journal: Ind Eng Chem Res Date: 2016-10-27 Impact factor: 3.720