Il pancreas artificiale in età pediatrica: Prima esperienza Italiana

Translated title of the contribution: The artificial pancreas in children: First tests in Italy

F. Boscari, S. Del Favero, M. Messori, I. Rabbone, R. Bonfanti, A. Sabbion, D. Iafusco, R. Schiaffini, R. Visentin, R. Calore, Y. Leal, S. Galasso, A. Galderisi, V. Vallone, F. Di Palma, E. Losiouk, G. Lanzola, D. Tinti, A. Rigamonti, M. MariglianoA. Zanfardino, N. Rapini, A. Avogaro, D. Chernavvsky, L. Magni, C. Cobelli, Daniela Bruttomesso

Research output: Contribution to journalArticle

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 languageItalian
Pages (from-to)125-133
Number of pages9
JournalGiornale Italiano di Diabetologia e Metabolismo
Volume36
Issue number3
Publication statusPublished - Sep 1 2016

Fingerprint

Artificial Pancreas
Italy
Outpatients
Type 1 Diabetes Mellitus
Pediatrics
Feasibility Studies
Hypoglycemia
Cross-Over Studies
Reference Values
Therapeutics
Parents
Safety
Glucose

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Boscari, F., Del Favero, S., Messori, M., Rabbone, I., Bonfanti, R., Sabbion, A., ... Bruttomesso, D. (2016). Il pancreas artificiale in età pediatrica: Prima esperienza Italiana. Giornale Italiano di Diabetologia e Metabolismo, 36(3), 125-133.

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 journalArticle

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, D 2016, 'Il pancreas artificiale in età pediatrica: Prima esperienza Italiana', Giornale Italiano di Diabetologia e Metabolismo, vol. 36, no. 3, pp. 125-133.
Boscari F, Del Favero S, Messori M, Rabbone I, Bonfanti R, Sabbion A et al. Il pancreas artificiale in età pediatrica: Prima esperienza Italiana. Giornale Italiano di Diabetologia e Metabolismo. 2016 Sep 1;36(3):125-133.
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. / Il pancreas artificiale in età pediatrica : Prima esperienza Italiana. In: Giornale Italiano di Diabetologia e Metabolismo. 2016 ; Vol. 36, No. 3. pp. 125-133.
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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.",
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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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