TY - JOUR
T1 - Il pancreas artificiale in età pediatrica
T2 - Prima esperienza Italiana
AU - Boscari, F.
AU - Del Favero, S.
AU - Messori, M.
AU - Rabbone, I.
AU - Bonfanti, R.
AU - Sabbion, A.
AU - Iafusco, D.
AU - Schiaffini, R.
AU - Visentin, R.
AU - Calore, R.
AU - Leal, Y.
AU - Galasso, S.
AU - Galderisi, A.
AU - Vallone, V.
AU - Di Palma, F.
AU - Losiouk, E.
AU - Lanzola, G.
AU - Tinti, D.
AU - Rigamonti, A.
AU - Marigliano, M.
AU - Zanfardino, A.
AU - Rapini, N.
AU - Avogaro, A.
AU - Chernavvsky, D.
AU - Magni, L.
AU - Cobelli, C.
AU - Bruttomesso, Daniela
PY - 2016/9/1
Y1 - 2016/9/1
N2 - Background. The artificial pancreas (AP) system based on the Modular Model Predictive Control algorithm (MMPC) running on the wearable platform Diabetes Assistant (DiAs) has been used in adult outpatients with type 1 diabetes (T1D), reducing the time spent in hypoglycemia and increasing the time spent in the near-normal range of 70-180 mg/dl compared to Sensor Augmented Pump therapy (SAP). Objective. In the PEDiatric ARtificial PANcreas (PedArPan) project we tested a children-specific version of the MMPC on DiAs in 5-9 yearold children during a summer camp. This is the first outpatient AP trial in a population of this age. Study design and methods. Thirty 5-9 year-old children with T1D and their parents were recruited from five Italian pediatric centers and completed an open label, randomized, crossover trial in a summer camp (supervised outpatient setting). Glucose control in three days of AP use was compared with three days of parent-managed SAP. Results. Overnight (00:00-07:30). The AP significantly reduced time-in-hypo compared to SAP, 0% [0.00-2.22] vs. 2.19% [0.00- 12.30], p = 0.002, with no significant difference in time-in-target (70-180 mg/dl), 55.97% (22.53) vs. 59.69% (21.24), p = 0.430, or time-in-tight-target (80-140 mg/dl), 31.27% (20.23) vs. 33.02% (19.80), p = 0.694. Overall (00:00-24:00). There was a threefold reduction of time-in-hypo, 2.02% [1.17-4.54] vs. 6.67% [2.26-11.54], p < 0.001, with AP at the expense of some deterioration of time-in-target, 56.79% (13.47) vs. 63.09% (10.98), p = 0.022. Conclusions. This study showed the feasibility and safety of a wearable MMPC in young children. Next steps will include overnight testing at home and re-tuning the algorithm to boost efficacy during daytime.
AB - Background. The artificial pancreas (AP) system based on the Modular Model Predictive Control algorithm (MMPC) running on the wearable platform Diabetes Assistant (DiAs) has been used in adult outpatients with type 1 diabetes (T1D), reducing the time spent in hypoglycemia and increasing the time spent in the near-normal range of 70-180 mg/dl compared to Sensor Augmented Pump therapy (SAP). Objective. In the PEDiatric ARtificial PANcreas (PedArPan) project we tested a children-specific version of the MMPC on DiAs in 5-9 yearold children during a summer camp. This is the first outpatient AP trial in a population of this age. Study design and methods. Thirty 5-9 year-old children with T1D and their parents were recruited from five Italian pediatric centers and completed an open label, randomized, crossover trial in a summer camp (supervised outpatient setting). Glucose control in three days of AP use was compared with three days of parent-managed SAP. Results. Overnight (00:00-07:30). The AP significantly reduced time-in-hypo compared to SAP, 0% [0.00-2.22] vs. 2.19% [0.00- 12.30], p = 0.002, with no significant difference in time-in-target (70-180 mg/dl), 55.97% (22.53) vs. 59.69% (21.24), p = 0.430, or time-in-tight-target (80-140 mg/dl), 31.27% (20.23) vs. 33.02% (19.80), p = 0.694. Overall (00:00-24:00). There was a threefold reduction of time-in-hypo, 2.02% [1.17-4.54] vs. 6.67% [2.26-11.54], p < 0.001, with AP at the expense of some deterioration of time-in-target, 56.79% (13.47) vs. 63.09% (10.98), p = 0.022. Conclusions. This study showed the feasibility and safety of a wearable MMPC in young children. Next steps will include overnight testing at home and re-tuning the algorithm to boost efficacy during daytime.
KW - Artificial pancreas
KW - Hypoglycemia
KW - Type 1 diabetes mellitus in children
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M3 - Articolo
AN - SCOPUS:84988672734
VL - 36
SP - 125
EP - 133
JO - Giornale Italiano di Diabetologia
JF - Giornale Italiano di Diabetologia
SN - 1593-6104
IS - 3
ER -