BACKGROUND: The Bio-inspired Artificial Pancreas (BiAP) is a closed-loop insulin delivery system based on a mathematical model of beta-cell physiology and implemented in a microchip within a low-powered handheld device. We aimed to evaluate the safety and efficacy of the BiAP over 24 hours, followed by a substudy assessing the safety of the algorithm without and with partial meal announcement. Changes in lactate and 3-hydroxybutyrate concentrations were investigated for the first time during closed-loop. METHODS: This is a prospective randomized controlled open-label crossover study. Participants were randomly assigned to attend either a 24-hour closed-loop visit connected to the BiAP system or a 24-hour open-loop visit (standard insulin pump therapy). The primary outcome was percentage time spent in target range (3.9-10 mmol/l) measured by sensor glucose. Secondary outcomes included percentage time in hypoglycemia (<3.9 mmol/l) and hyperglycemia (>10 mmol/l). Participants were invited to attend for an additional visit to assess the BiAP without and with partial meal announcements. RESULTS: A total of 12 adults with type 1 diabetes completed the study (58% female, mean [SD] age 45 [10] years, BMI 25 [4] kg/m(2), duration of diabetes 22 [12] years and HbA1c 7.4 [0.7]% [58 (8) mmol/mol]). The median (IQR) percentage time in target did not differ between closed-loop and open-loop (71% vs 66.9%, P = .9). Closed-loop reduced time spent in hypoglycemia from 17.9% to 3.0% (P < .01), but increased time was spent in hyperglycemia (10% vs 28.9%, P = .01). The percentage time in target was higher when all meals were announced during closed-loop compared to no or partial meal announcement (65.7% [53.6-80.5] vs 45.5% [38.2-68.3], P = .12). CONCLUSIONS: The BiAP is safe and achieved equivalent time in target as measured by sensor glucose, with improvement in hypoglycemia, when compared to standard pump therapy.
BACKGROUND: The Bio-inspired Artificial Pancreas (BiAP) is a closed-loop insulin delivery system based on a mathematical model of beta-cell physiology and implemented in a microchip within a low-powered handheld device. We aimed to evaluate the safety and efficacy of the BiAP over 24 hours, followed by a substudy assessing the safety of the algorithm without and with partial meal announcement. Changes in lactate and 3-hydroxybutyrate concentrations were investigated for the first time during closed-loop. METHODS: This is a prospective randomized controlled open-label crossover study. Participants were randomly assigned to attend either a 24-hour closed-loop visit connected to the BiAP system or a 24-hour open-loop visit (standard insulin pump therapy). The primary outcome was percentage time spent in target range (3.9-10 mmol/l) measured by sensor glucose. Secondary outcomes included percentage time in hypoglycemia (<3.9 mmol/l) and hyperglycemia (>10 mmol/l). Participants were invited to attend for an additional visit to assess the BiAP without and with partial meal announcements. RESULTS: A total of 12 adults with type 1 diabetes completed the study (58% female, mean [SD] age 45 [10] years, BMI 25 [4] kg/m(2), duration of diabetes 22 [12] years and HbA1c 7.4 [0.7]% [58 (8) mmol/mol]). The median (IQR) percentage time in target did not differ between closed-loop and open-loop (71% vs 66.9%, P = .9). Closed-loop reduced time spent in hypoglycemia from 17.9% to 3.0% (P < .01), but increased time was spent in hyperglycemia (10% vs 28.9%, P = .01). The percentage time in target was higher when all meals were announced during closed-loop compared to no or partial meal announcement (65.7% [53.6-80.5] vs 45.5% [38.2-68.3], P = .12). CONCLUSIONS: The BiAP is safe and achieved equivalent time in target as measured by sensor glucose, with improvement in hypoglycemia, when compared to standard pump therapy.
Authors: Marc Breton; Anne Farret; Daniela Bruttomesso; Stacey Anderson; Lalo Magni; Stephen Patek; Chiara Dalla Man; Jerome Place; Susan Demartini; Simone Del Favero; Chiara Toffanin; Colleen Hughes-Karvetski; Eyal Dassau; Howard Zisser; Francis J Doyle; Giuseppe De Nicolao; Angelo Avogaro; Claudio Cobelli; Eric Renard; Boris Kovatchev Journal: Diabetes Date: 2012-06-11 Impact factor: 9.461
Authors: Steven J Russell; Firas H El-Khatib; Manasi Sinha; Kendra L Magyar; Katherine McKeon; Laura G Goergen; Courtney Balliro; Mallory A Hillard; David M Nathan; Edward R Damiano Journal: N Engl J Med Date: 2014-06-15 Impact factor: 91.245
Authors: William V Tamborlane; Roy W Beck; Bruce W Bode; Bruce Buckingham; H Peter Chase; Robert Clemons; Rosanna Fiallo-Scharer; Larry A Fox; Lisa K Gilliam; Irl B Hirsch; Elbert S Huang; Craig Kollman; Aaron J Kowalski; Lori Laffel; Jean M Lawrence; Joyce Lee; Nelly Mauras; Michael O'Grady; Katrina J Ruedy; Michael Tansey; Eva Tsalikian; Stuart Weinzimer; Darrell M Wilson; Howard Wolpert; Tim Wysocki; Dongyuan Xing Journal: N Engl J Med Date: 2008-09-08 Impact factor: 91.245
Authors: Richard M Bergenstal; David C Klonoff; Satish K Garg; Bruce W Bode; Melissa Meredith; Robert H Slover; Andrew J Ahmann; John B Welsh; Scott W Lee; Francine R Kaufman Journal: N Engl J Med Date: 2013-06-22 Impact factor: 91.245
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: Trang T Ly; Marc D Breton; Patrick Keith-Hynes; Daniel De Salvo; Paula Clinton; Kari Benassi; Benton Mize; Daniel Chernavvsky; Jéróme Place; Darrell M Wilson; Boris P Kovatchev; Bruce A Buckingham Journal: Diabetes Care Date: 2014-05-30 Impact factor: 19.112