Randomized summer camp crossover trial in 5-to 9-year-old children: Outpatient wearable artificial pancreas is feasible and safe

Simone Del Favero, Federico Boscari, Mirko Messori, Ivana Rabbone, Riccardo Bonfanti, Alberto Sabbion, Dario Iafusco, Riccardo Schiaffini, Roberto Visentin, Roberta Calore, Yenny Leal Moncada, Silvia Galasso, Alfonso Galderisi, Valeria Vallone, Federico Di Palma, Eleonora Losiouk, Giordano Lanzola, Davide Tinti, Andrea Rigamonti, Marco MariglianoAngela Zanfardino, Novella Rapini, Angelo Avogaro, Daniel Chernavvsky, Lalo Magni, Claudio Cobelli, Daniela Bruttomesso

Research output: Contribution to journalArticlepeer-review

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-yearold 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 sensoraugmented pump (SAP). RESULTS Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25th-75thpercentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P 5 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.

Original languageEnglish
Pages (from-to)1180-1185
Number of pages6
JournalDiabetes Care
Volume39
Issue number7
DOIs
Publication statusPublished - Jul 1 2016

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialised Nursing

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