التفاصيل البيبلوغرافية
| العنوان: |
Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe. |
| المؤلفون: |
Del Favero, Simone, Boscari, Federico, Messori, Mirko, Rabbone, Ivana, Bonfanti, Riccardo, Sabbion, Alberto, Iafusco, Dario, Schiaffini, Riccardo, Visentin, Roberto, Calore, Roberta, Moncada, Yenny Leal, Galasso, Silvia, Galderisi, Alfonso, Vallone, Valeria, Di Palma, Federico, Losiouk, Eleonora, Lanzola, Giordano, Tinti, Davide, Rigamonti, Andrea, Marigliano, Marco |
| المصدر: |
Diabetes Care; Jul2016, Vol. 39 Issue 7, p1180-1185, 6p, 1 Chart, 1 Graph |
| مصطلحات موضوعية: |
ARTIFICIAL pancreases, ARTIFICIAL organs, DRUG efficacy, MEDICATION safety, JUVENILE diseases, THERAPEUTICS, BLOOD sugar analysis, INSULIN therapy, HYPOGLYCEMIC agents, ALGORITHMS, COMPARATIVE studies, CROSSOVER trials, HYPOGLYCEMIA, INSULIN pumps, TYPE 1 diabetes, RESEARCH methodology, MEDICAL cooperation, RESEARCH, PILOT projects, EVALUATION research, RANDOMIZED controlled trials, PREVENTION |
| مستخلص: |
Objective: The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5- to 9-year-old 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 sensor-augmented pump (SAP).Results: Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25(th)-75(th) percentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P = 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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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