OBJECTIVE: The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5- to 9-year-old 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 sensor-augmented pump (SAP). RESULTS: Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25(th)-75(th) percentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P = 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.

Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

Rabbone, Ivana;Tinti, Davide;
2016

Abstract

OBJECTIVE: The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5- to 9-year-old 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 sensor-augmented pump (SAP). RESULTS: Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25(th)-75(th) percentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P = 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.
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http://care.diabetesjournals.org/content/39/7/1180.long
Algorithms; Blood Glucose; Child; Child, Preschool; Cross-Over Studies; Diabetes Mellitus, Type 1; Feasibility Studies; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Infusion Systems; Male; Pancreas, Artificial
Del Favero, Simone; Boscari, Federico; Messori, Mirko; Rabbone, Ivana; Bonfanti, Riccardo; Sabbion, Alberto; Iafusco, Dario; Schiaffini, Riccardo; Visentin, Roberto; Calore, Roberta; Moncada, Yenny Leal; Galasso, Silvia; Galderisi, Alfonso; Vallone, Valeria; Di Palma, Federico; Losiouk, Eleonora; Lanzola, Giordano; Tinti, Davide; Rigamonti, Andrea; Marigliano, Marco; Zanfardino, Angela; Rapini, Novella; Avogaro, Angelo; Chernavvsky, Daniel; Magni, Lalo; Cobelli, Claudio; Bruttomesso, Daniela
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2318/1703906
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