Nocturnal glucose control with an artificial pancreas at a diabetes camp

New England Journal of Medicine

Volumn 368, Issue 9, 2013, Pages 824-833

  Phillip, Moshe ^a,b   Battelino, Tadej ^c   Atlas, Eran ^a   Kordonouri, Olga ^d   Bratina, Natasa ^c   Miller, Shahar ^a   Biester, Torben ^d   Stefanija, Magdalena Avbelj ^c   Muller, Ido ^a   Nimri, Revital ^a   Danne, Thomas ^d  

^a SCHNEIDER CHILDREN S MEDICAL CENTER OF ISRAEL   (Israel)

^b TEL AVIV UNIVERSITY   (Israel)

^c UNIVERSITY CHILDREN S HOSPITAL   (Slovenia)

^d Diabetes Center for Children and Adolescents   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

GLYCOSYLATED HEMOGLOBIN; INSULIN;

ADULT; ADVERSE OUTCOME; ARTICLE; ARTIFICIAL PANCREAS; BLOOD GLUCOSE MONITORING; CHILD; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEVICE SAFETY; DIZZINESS; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN PUMP; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NOCTURNAL HYPOGLYCEMIA; OUTCOME ASSESSMENT; PATIENT SAFETY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SCHOOL CHILD;

EID: 84874368884     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1206881     Document Type: Article

References (35)

1. Pickup JC. Insulin-pump therapy for type 1 diabetes mellitus. N Engl J Med 2012;366:1616-24.
2. Phillip M, Battelino T, Rodriguez H, et al. Use of insulin pump therapy in the pediatric age-group: consensus statement from the European Society for Paediatric Endocrinology, the Lawson Wilkins Pediatric Endocrine Society, and the International Society for Pediatric and Adolescent Diabetes, endorsed by the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2007;30:1653-62.
3. Phillip M, Danne T, Shalitin S, et al. Use of continuous glucose monitoring in children and adolescents. Pediatr Diabetes 2012;13:215-28.
4. Deiss D, Hartmann R, Hoeffe J, Kordonouri O. Assessment of glycemic control by continuous glucose monitoring system in 50 children with type 1 diabetes starting on insulin pump therapy. Pediatr Diabetes 2004;5:117-21.
5. Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care 2011;34:795-800.
6. Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 2010;363:311-20. [Erratum, N Engl J Med 2010;363:1092.]
7. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
8. The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Prolonged nocturnal hypoglycemia is common during 12 months of continuous glucose monitoring in children and adults with type 1 diabetes. Diabetes Care 2010;33:1004-8.
9. Davis EA, Keating B, Byrne GC, Russell M, Jones TW. Hypoglycemia: incidence and clinical predictors in a large population-based sample of children and adolescents with IDDM. Diabetes Care 1997;20:22-5.
10. Sovik O, Thordarson H. Dead-in-bed syndrome in young diabetic patients. Diabetes Care 1999;22:Suppl 2:B40-B42. [Erratum, Diabetes Care 1999;22:1389.]
11. Hovorka R, Allen J, Elleri D, et al. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet 2010;375:743-51.
12. Elleri D, Allen JM, Nodale M, et al. Automated overnight closed-loop glucose control in young children with type 1 diabetes. Diabetes Technol Ther 2011;13:419-24.
13. Hovorka R, Kumareswaran K, Harris J, et al. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies. BMJ 2011;342:d1855.
14. Kovatchev B, Cobelli C, Renard E, et al. Multinational study of subcutaneous model-predictive closed-loop control in type 1 diabetes mellitus: summary of the results. J Diabetes Sci Technol 2010;4:1374-81.
15. Atlas E, Nimri R, Miller S, Grunberg EA, Phillip M. MD-Logic Artificial Pancreas system: a pilot study in adults with type 1 diabetes. Diabetes Care 2010;33:1072-6.
16. Miller S, Nimri R, Atlas E, Grunberg EA, Phillip M. Automatic learning algorithm for the MD-Logic Artificial Pancreas system. Diabetes Technol Ther 2011;13:983-90.
17. Nimri R, Atlas E, Ajzensztejn M, Miller S, Oron T, Phillip M. Feasibility study of automated overnight closed-loop glucose control under MD-Logic Artificial Pancreas in patients with type 1 diabetes: the DREAM Project. Diabetes Technol Ther 2012;14:728-35.
18. Ciambra R, Locatelli C, Suprani T, Pocecco M. Management of diabetes at summer camps. Acta Biomed 2005;76:Suppl 3:81-4.
19. Gunasekera H, Ambler G. Safety and efficacy of blood glucose management practices at a diabetes camp. J Paediatr Child Health 2006;42:643-8.
20. Miller AR, Nebesio TD, DiMeglio LA. Insulin dose changes in children attending a residential diabetes camp. Diabet Med 2011;28:480-6.
21. Robertson K, Adolfsson P, Scheiner G, Hanas R, Riddell MC. Exercise in children and adolescents with diabetes. Pediatr Diabetes 2009;10:Suppl 12:154-68.
22. Guidance for industry and Food and Drug Administration staff: the content of investigational device exemption (IDE) and premarket approval (PMA) applications for artificial pancreas device systems. Rockville, MD: Food and Drug Administration, 2011 (http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM259305.pdf).
23. Magni L, Raimondo DM, Man CD, et al. Evaluating the efficacy of closed-loop glucose regulation via control-variability grid analysis. J Diabetes Sci Technol 2008;2:630-5.
24. Kovatchev BP, Gonder-Frederick LA, Cox DJ, Clarke WL. Evaluating the accuracy of continuous glucose monitoring systems: continuous glucose-error grid analysis illustrated by TheraSense Freestyle Navigator data. Diabetes Care 2004;27:1922-8.
25. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988;75:800-2.
26. Kovatchev BP, Otto E, Cox D, Gonder-Frederick L, Clarke W. Evaluation of a new measure of blood glucose variability in diabetes. Diabetes Care 2006;29:2433-8.
27. McCall AL, Cox DJ, Crean J, Gloster M, Kovatchev BP. A novel analytical method for assessing glucose variability: using CGMS in type 1 diabetes mellitus. Diabetes Technol Ther 2006;8:644-53.
28. Mauras N, Beck R, Xing D, et al. A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years. Diabetes Care 2012;35:204-10.
29. Barnard K, Thomas S, Royle P, Noyes K, Waugh N. Fear of hypoglycemia in parents of young children with type 1 diabetes: a systematic review. BMC Pediatr 2010;10:50.
30. Monaghan MC, Hilliard ME, Cogen FR, Streisand R. Nighttime caregiving behaviors among parents of young children with Type 1 diabetes: associations with illness characteristics and parent functioning. Fam Syst Health 2009;27:28-38.
31. Elleri D, Acerini CL, Allen JM, et al. Parental attitudes towards overnight closed-loop glucose control in children with type 1 diabetes. Diabetes Technol Ther 2010;12:35-9.
32. Hughes CS, Patek SD, Breton MD, Kovatchev BP. Hypoglycemia prevention via pump attenuation and red-yellow-green "traffic" lights using continuous glucose monitoring and insulin pump data. J Diabetes Sci Technol 2010;4:1146-55.
33. The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008;359:1464-76.
34. Hovorka R, Nodale M, Haidar A, Wilinska ME. Assessing performance of closed-loop insulin delivery system by continuous glucose monitoring: drawbacks and way forward. Diabetes Technol Ther 2012 October 9 (Epub ahead of print).
35. Keenan DB, Mastrototaro JJ, Zisser H, et al. Accuracy of the Enlite 6-day glucose sensor with guardian and Veo calibration algorithms. Diabetes Technol Ther 2012;14:225-31.