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.
|Titolo:||Il pancreas artificiale in età pediatrica: Prima esperienza Italiana|
|Autori interni:||IAFUSCO, Dario|
|Data di pubblicazione:||2016|
|Rivista:||GIDM. GIORNALE ITALIANO DI DIABETOLOGIA E METABOLISMO|
|Appare nelle tipologie:||1.1 Articolo in rivista|