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

Diabetes Care

Volumn 39, Issue 7, 2016, Pages 1180-1185

  Del Favero, Simone ^a   Boscari, Federico ^a   Messori, Mirko ^b   Rabbone, Ivana ^c   Bonfanti, Riccardo ^d   Sabbion, Alberto ^e   Iafusco, Dario ^f   Schiaffini, Riccardo ^g   Visentin, Roberto ^a   Calore, Roberta ^a   Moncada, Yenny Leal ^a   Galasso, Silvia ^a   Galderisi, Alfonso ^a   Vallone, Valeria ^a   Di Palma, Federico ^b   Losiouk, Eleonora ^b   Lanzola, Giordano ^b   Tinti, Davide ^c   Rigamonti, Andrea ^d   Marigliano, Marco ^e   Zanfardino, Angela ^f   Rapini, Novella ^h   Avogaro, Angelo ^a   Chernavvsky, Daniel ⁱ   Magni, Lalo ^b   Cobelli, Claudio ^a   Bruttomesso, Daniela ^a   more..

^a UNIVERSITY OF PADOVA   (Italy)

^b UNIVERSITY OF PAVIA   (Italy)

^c UNIVERSITY OF TURIN   (Italy)

^d SAN RAFFAELE HOSPITAL   (Italy)

^e UNIVERSITY HOSPITAL OF VERONA   (Italy)

^f SECOND UNIVERSITY OF NAPLES   (Italy)

^g BAMBINO GESÙ CHILDREN S HOSPITAL   (Italy)

^h TOR VERGATA UNIVERSITY HOSPITAL   (Italy)

ⁱ UNIVERSITY OF VIRGINIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTIFICIAL PANCREAS; BIOSENSOR; CHILD; CLINICAL ARTICLE; CONFERENCE PAPER; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEVICE SAFETY; FEASIBILITY STUDY; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN PUMP; MALE; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SENSOR AUGMENTED PUMP; ALGORITHM; ANALYSIS; DIABETES MELLITUS, TYPE 1; INSULIN INFUSION; PRESCHOOL CHILD;

ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; INSULIN;

ALGORITHMS; BLOOD GLUCOSE; CHILD; CHILD, PRESCHOOL; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; FEASIBILITY STUDIES; FEMALE; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN INFUSION SYSTEMS; MALE; PANCREAS, ARTIFICIAL;

EID: 84992229896     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc15-2815     Document Type: Article

References (16)

1. Dauber A, Corcia L, Safer J, Agus MS, Einis S, Steil GM. Closed-loop insulin therapy improves glycemic control in children aged <7 years: a randomized controlled trial. Diabetes Care 2013;36:222-227
2. Elleri D, Allen JM, Tauschmann M, et al. Feasibility of overnight closed-loop therapy in young children with type 1 diabetes aged 3-6 years: comparison between diluted and standard insulin strength. BMJ Open Diabetes Res Care 2014;2:e000040
3. Russell SJ, Hillard MA, Balliro C, et al. Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial. Lancet Diabetes Endocrinol 2016;4:233-243
4. Patek SD, Magni L, Dassau E, et al.; International Artificial Pancreas (iAP) Study Group. Modular closed-loop control of diabetes. IEEE Trans Biomed Eng 2012;59:2986-2999
5. Toffanin C, Messori M, Di Palma F, De Nicolao G, Cobelli C, Magni L Artificial pancreas: model predictive control design from clinical experience. J Diabetes Sci Technol 2013;7: 1470-1483
6. Keith-Hynes P, Mize B, Robert A, Place J. The Diabetes Assistant: a smartphone-based system for real-time control of blood glucose. Electronics (Basel) 2014;3:609-623
7. Ruan Y, Elleri D, Allen JM, et al. Pharmacokinetics of diluted (U20) insulin aspart compared with standard (U100) in children aged 3-6 years with type 1 diabetes during closed-loop insulin delivery: a randomised clinical trial. Diabetologia 2015;58:687-690
8. Kovatchev BP, Cox DJ, Gonder-Frederick L, Clarke WL. Methods for quantifying self-monitoring blood glucose profiles exemplified by an examination of blood glucose patterns in patients with type 1 and type 2 diabetes. Diabetes Technol Ther 2002;4:295-303
9. Senn S. Cross-over trials in Statistics in Medicine: the first '25' years. Stat Med 2006; 25:3430-3442
10. Kropff J, Del Favero S, Place J, et al.; AP@home consortium. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol 2015;3:939-947
11. Ly TT, Breton MD, Keith-Hynes P, et al. Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. Diabetes Care 2014;37:2310-2316
12. Danne T, Battelino T, Jarosz-Chobot P, et al.; PedPump Study Group. Establishing glycaemic control with continuous subcutaneous insulin infusion in children and adolescents with type 1 diabetes: experience of the PedPump Study in 17 countries. Diabetologia 2008;51: 1594-1601
13. Matyka KA, Crowne EC, Havel PJ, Macdonald IA, Matthews D, Dunger DB. Counterregulation during spontaneous nocturnal hypoglycemia in prepubertal children with type 1 diabetes. Diabetes Care 1999;22:1144-1150
14. Breton M, Farret A, Bruttomesso D, et al.; International Artificial Pancreas Study Group. Fully integrated artificial pancreas in type 1 diabetes: modular closed-loop glucose control maintains near normoglycemia. Diabetes 2012; 61:2230-2237
15. Del Favero S, Place J, Kropff J, et al.; AP@home Consortium. Multicenter outpatient dinner/overnight reduction of hypoglycemia and increased time of glucose in target with a wearable artificial pancreas using modular model predictive control in adults with type 1 diabetes. Diabetes Obes Metab 2015; 17:468-476
16. Thabit H, Tauschmann M, Allen JM, et al.; APCam Consortium; AP@home Consortium. Home use of an artificial Beta cell in type 1 diabetes. N Engl J Med 2015;373:2129-2140