TY - JOUR
T1 - Randomized summer camp crossover trial in 5-to 9-year-old children
T2 - Outpatient wearable artificial pancreas is feasible and safe
AU - Del Favero, Simone
AU - Boscari, Federico
AU - Messori, Mirko
AU - Rabbone, Ivana
AU - Bonfanti, Riccardo
AU - Sabbion, Alberto
AU - Iafusco, Dario
AU - Schiaffini, Riccardo
AU - Visentin, Roberto
AU - Calore, Roberta
AU - Moncada, Yenny Leal
AU - Galasso, Silvia
AU - Galderisi, Alfonso
AU - Vallone, Valeria
AU - Di Palma, Federico
AU - Losiouk, Eleonora
AU - Lanzola, Giordano
AU - Tinti, Davide
AU - Rigamonti, Andrea
AU - Marigliano, Marco
AU - Zanfardino, Angela
AU - Rapini, Novella
AU - Avogaro, Angelo
AU - Chernavvsky, Daniel
AU - Magni, Lalo
AU - Cobelli, Claudio
AU - Bruttomesso, Daniela
N1 - Publisher Copyright:
© 2016 by the American Diabetes Association.
PY - 2016/7/1
Y1 - 2016/7/1
N2 - Objective The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5-to 9-yearold children during a camp. RESEARCH DESIGN AND METHODS A total of 30 children, 5-to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensoraugmented pump (SAP). RESULTS Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25th-75thpercentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P 5 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P < 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P < 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (13.5) vs. 63.1% (11.0) (P < 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001). CONCLUSIONS This trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.
AB - Objective The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5-to 9-yearold children during a camp. RESEARCH DESIGN AND METHODS A total of 30 children, 5-to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensoraugmented pump (SAP). RESULTS Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25th-75thpercentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P 5 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P < 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P < 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (13.5) vs. 63.1% (11.0) (P < 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001). CONCLUSIONS This trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.
UR - http://www.scopus.com/inward/record.url?scp=84992229896&partnerID=8YFLogxK
U2 - 10.2337/dc15-2815
DO - 10.2337/dc15-2815
M3 - Article
SN - 0149-5992
VL - 39
SP - 1180
EP - 1185
JO - Diabetes Care
JF - Diabetes Care
IS - 7
ER -
