Abstract
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.
| Original language | Italian |
|---|---|
| Pages (from-to) | 125-133 |
| Number of pages | 9 |
| Journal | Giornale Italiano di Diabetologia e Metabolismo |
| Volume | 36 |
| Issue number | 3 |
| Publication status | Published - Sep 1 2016 |
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ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
- Endocrinology
Cite this
Il pancreas artificiale in età pediatrica : Prima esperienza Italiana. / Boscari, F.; Del Favero, S.; Messori, M.; Rabbone, I.; Bonfanti, R.; Sabbion, A.; Iafusco, D.; Schiaffini, R.; Visentin, R.; Calore, R.; Leal, Y.; Galasso, S.; Galderisi, A.; Vallone, V.; Di Palma, F.; Losiouk, E.; Lanzola, G.; Tinti, D.; Rigamonti, A.; Marigliano, M.; Zanfardino, A.; Rapini, N.; Avogaro, A.; Chernavvsky, D.; Magni, L.; Cobelli, C.; Bruttomesso, Daniela.
In: Giornale Italiano di Diabetologia e Metabolismo, Vol. 36, No. 3, 01.09.2016, p. 125-133.Research output: Contribution to journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=84988672734&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84988672734&partnerID=8YFLogxK
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 -