메뉴 건너뛰기




Volumn 38, Issue 4, 2015, Pages 716-722

Insulin pump risks and benefits: A clinical appraisal of pump safety standards, adverse event reporting, and research needs

Author keywords

[No Author keywords available]

Indexed keywords

INSULIN; INSULIN GLULISINE;

EID: 84939808599     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc15-0168     Document Type: Article
Times cited : (115)

References (30)
  • 1
    • 0017834105 scopus 로고
    • Continuous subcutaneous insulin infusion: An approach to achieving normoglycaemia
    • Pickup JC, Keen H, Parsons JA, Alberti KG. Continuous subcutaneous insulin infusion: An approach to achieving normoglycaemia. BMJ 1978;1:204-207.
    • (1978) BMJ , vol.1 , pp. 204-207
    • Pickup, J.C.1    Keen, H.2    Parsons, J.A.3    Alberti, K.G.4
  • 2
    • 84882416690 scopus 로고    scopus 로고
    • Insulin pumps
    • Pickup J. Insulin pumps. Diabetes Technol Ther 2013;15(Suppl. 1):S24-S28.
    • (2013) Diabetes Technol Ther , vol.15 , pp. S24-S28
    • Pickup, J.1
  • 3
    • 84884610823 scopus 로고    scopus 로고
    • Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: A randomized clinical trial
    • Ly TT, Nicholas JA, Retterath A, LimEM, Davis EA, Jones TW. Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: A randomized clinical trial. JAMA 2013;310: 1240-1247.
    • (2013) JAMA , vol.310 , pp. 1240-1247
    • Ly, T.T.1    Nicholas, J.A.2    Retterath, A.3    LimE, M.4    Davis, E.A.5    Jones, T.W.6
  • 4
    • 84880274350 scopus 로고    scopus 로고
    • Thresholdbased insulin-pump interruption for reduction of hypoglycemia
    • ASPIRE In-Home Study Group
    • Bergenstal RM, Klonoff DC, Garg SK, et al.; ASPIRE In-Home Study Group. Thresholdbased insulin-pump interruption for reduction of hypoglycemia. N Engl J Med 2013; 369:224-232.
    • (2013) N Engl J Med , vol.369 , pp. 224-232
    • Bergenstal, R.M.1    Klonoff, D.C.2    Garg, S.K.3
  • 5
    • 84900459379 scopus 로고    scopus 로고
    • Consensus statement by the American association of clinical endocrinologists/American college of endocrinology insulin pumpmanagement task force
    • Grunberger G, Abelseth JM, Bailey TS, et al. Consensus statement by the American Association of Clinical Endocrinologists/American College of Endocrinology Insulin PumpManagement Task Force. Endocr Pract 2014;20:463-489.
    • (2014) Endocr Pract , vol.20 , pp. 463-489
    • Grunberger, G.1    Abelseth, J.M.2    Bailey, T.S.3
  • 6
    • 84962160671 scopus 로고    scopus 로고
    • Diabetes UK. Insulin pumptherapy. Position statement (updated September 2011). Available from, Accessed 24 December
    • Diabetes UK. Insulin pumptherapy. Also known as continuous subcutaneous insulin infusion (CSII). Position statement (updated September 2011). Available from www.diabetes.org.uk/Documents/Position%20statements/Position-Statment-Insulin-pump-therapy090911.pdf. Accessed 24 December 2014.
    • (2014) Also Known as Continuous Subcutaneous Insulin Infusion (CSII)
  • 7
    • 77955743980 scopus 로고    scopus 로고
    • The use of insulin pumps in youth with type 1 diabetes
    • Maahs DM, Horton LA, Chase HP. The use of insulin pumps in youth with type 1 diabetes. Diabetes Technol Ther 2010;12(Suppl. 1):S59-S65.
    • (2010) Diabetes Technol Ther , vol.12 , pp. S59-S65
    • Maahs, D.M.1    Horton, L.A.2    Chase, H.P.3
  • 9
    • 84962165953 scopus 로고    scopus 로고
    • Close concerns
    • [Internet], Available from, Accessed 24 December 2014
    • Close Concerns.Medtronic issues class II recall for MiniMed Paradigm and 530G systems [Internet], 2014. Available from www.closeconcerns.com/knowledgebase/r/846b6e3d. Accessed 24 December 2014.
    • (2014) Medtronic Issues Class II Recall for MiniMed Paradigm and 530G Systems
  • 10
    • 85020810710 scopus 로고    scopus 로고
    • Infusion pumps total product life cycle
    • US Food and Drug Administration.[Internet], Available from, Accessed 22 January 2015
    • US Food and Drug Administration. Infusion pumps total product life cycle. Guidance for industry and FDA staff [Internet], 2014. Available from www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM209337.pdf. Accessed 22 January 2015.
    • (2014) Guidance for Industry and FDA Staff
  • 12
    • 3543094702 scopus 로고    scopus 로고
    • US Food and Drug Administration. (K97-1) [Internet], Available from, Accessed 25 October 2014
    • US Food and Drug Administration. Deciding when to submit a 510(k) for a change to an existing device (K97-1) [Internet], 1997. Available from www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm. Accessed 25 October 2014.
    • (1997) Deciding When to Submit a 510(k) for a Change to An Existing Device
  • 13
    • 0010448659 scopus 로고
    • Council of the European Union. [Internet], Available from, Accessed 25 October 2014
    • Council of the European Union. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [Internet], 1993. Available from http://eur-lex.europa.eu/legal-content/en/ALL/;ELX-SESSIONID5YJQGJLGd1JrpT98QbJKC8KMcchrTtQfzj1fjznyTjVv1p2vfp6bh!283099387?uri5CELEX:31993L0042. Accessed 25 October 2014.
    • (1993) Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices
  • 14
    • 84857885489 scopus 로고    scopus 로고
    • Regulation of medical devices in the United States and european union
    • Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. N Engl J Med 2012;366:848-855.
    • (2012) N Engl J Med , vol.366 , pp. 848-855
    • Kramer, D.B.1    Xu, S.2    Kesselheim, A.S.3
  • 15
    • 84962194058 scopus 로고    scopus 로고
    • European commission dg health and consumers (SANCO)
    • [Internet], Available from, Accessed 11 November 2014
    • European Commission DG Health and Consumers (SANCO). Guidelines on aMedical Devices Vigilance System [Internet], 2013. Available from http://ec.europa.eu/health/medical-devices/files/meddev/2-12-1-ol-en.pdf Accessed 11 November 2014.
    • (2013) Guidelines on AMedical Devices Vigilance System
  • 16
    • 44449108280 scopus 로고    scopus 로고
    • Adolescent use of insulin and patient-controlled analgesia pump technology: A 10-year food and drug administration retrospective study of adverse events
    • Cope JU, Morrison AE, Samuels-Reid J. Adolescent use of insulin and patient-controlled analgesia pump technology: A 10-year Food and Drug Administration retrospective study of adverse events. Pediatrics 2008;121: e1133-e1138.
    • (2008) Pediatrics , vol.121 , pp. e1133-e1138
    • Cope, J.U.1    Morrison, A.E.2    Samuels-Reid, J.3
  • 17
    • 84973273591 scopus 로고    scopus 로고
    • Absorption kinetics of insulin following subcutaneous bolus administration with different bolus durations
    • Regittnig W, Urschitz M, Lehki B, et al. Absorption kinetics of insulin following subcutaneous bolus administration with different bolus durations. Diabetes 2013;62(Suppl. 1):A247.
    • (2013) Diabetes , vol.62 , pp. A247
    • Regittnig, W.1    Urschitz, M.2    Lehki, B.3
  • 18
    • 77956140821 scopus 로고    scopus 로고
    • Insulin pump therapy: What is the evidence for using different types of boluses for coverage of prandial insulin requirements?
    • Heinemann L. Insulin pump therapy: what is the evidence for using different types of boluses for coverage of prandial insulin requirements? J Diabetes Sci Tech 2009;3:1490-1500.
    • (2009) J Diabetes Sci Tech , vol.3 , pp. 1490-1500
    • Heinemann, L.1
  • 19
    • 84962144278 scopus 로고    scopus 로고
    • US Food and Drug Administration. [Internet], Available from, Accessed 25 October 2014
    • US Food and Drug Administration. Human factors and medical devices [Internet], 2014. Available from www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/. Accessed 25 October 2014.
    • (2014) Human Factors and Medical Devices
  • 20
    • 84885935507 scopus 로고    scopus 로고
    • Prevalence and risk factors of lipohypertrophy in insulin-injecting patients with diabetes
    • Blanco M, Hernandez MT, Strauss KW, Amaya M. Prevalence and risk factors of lipohypertrophy in insulin-injecting patients with diabetes. Diabetes Metab 2013;39:445-453.
    • (2013) Diabetes Metab , vol.39 , pp. 445-453
    • Blanco, M.1    Hern, M.T.2    Strauss, K.W.3    Amaya, M.4
  • 21
    • 84869080901 scopus 로고    scopus 로고
    • Insulin infusion set: The Achilles heel of continuous subcutaneous insulin infusion
    • Heinemann L, Krinelke L. Insulin infusion set: the Achilles heel of continuous subcutaneous insulin infusion. J Diabetes Sci Tech 2012;6:954-964.
    • (2012) J Diabetes Sci Tech , vol.6 , pp. 954-964
    • Heinemann, L.1    Krinelke, L.2
  • 22
    • 0022458650 scopus 로고
    • Malfunction of continuous subcutaneous insulin infusion systems: A oneyear prospective study of 127 patients
    • Mecklenburg RS, Guinn TS, Sannar CA, Blumenstein BA. Malfunction of continuous subcutaneous insulin infusion systems: A oneyear prospective study of 127 patients. Diabetes Care 1986;9:351-355.
    • (1986) Diabetes Care , vol.9 , pp. 351-355
    • Mecklenburg, R.S.1    Guinn, T.S.2    Sannar, C.A.3    Blumenstein, B.A.4
  • 23
    • 84896403138 scopus 로고    scopus 로고
    • A contrast between children and adolescents with excellent and poor control: The T1D exchange clinic registry experience
    • T1D Exchange Clinic Network
    • Campbell MS, Schatz DA, Chen V, et al.; T1D Exchange Clinic Network. A contrast between children and adolescents with excellent and poor control: the T1D Exchange clinic registry experience. Pediatr Diabetes 2014;15: 110-117.
    • (2014) Pediatr Diabetes , vol.15 , pp. 110-117
    • Campbell, M.S.1    Schatz, D.A.2    Chen, V.3
  • 24
    • 84891840841 scopus 로고    scopus 로고
    • Differences in the management of type 1 diabetes among adults under excellent control compared with those under poor control in the T1D exchange clinic registry
    • T1D Exchange Clinic Network
    • Simmons JH, Chen V, Miller KM, et al.; T1D Exchange Clinic Network. Differences in the management of type 1 diabetes among adults under excellent control compared with those under poor control in the T1D Exchange Clinic Registry. Diabetes Care 2013; 36:3573-3577.
    • (2013) Diabetes Care , vol.36 , pp. 3573-3577
    • Simmons, J.H.1    Chen, V.2    Miller, K.M.3
  • 26
    • 84973255891 scopus 로고    scopus 로고
    • Insulin pumps (CSII) and cardiovascular diseases and mortality in the Swedish national diabetes register
    • Gudbjornsdottir S, Eliasson B, Svensson AM, et al. Insulin pumps (CSII) and cardiovascular diseases and mortality in the Swedish national diabetes register. Diabetologia 2014; 57(Suppl.1):A196.
    • (2014) Diabetologia , vol.57 , pp. A196
    • Gudbjornsdottir, S.1    Eliasson, B.2    Svensson, A.M.3
  • 28
    • 70949107024 scopus 로고    scopus 로고
    • Insulin pump failures are still frequent: A prospective study over 6 years from 2001 to 2007
    • Guilhem I, Balkau B, Lecordier F, et al. Insulin pump failures are still frequent: A prospective study over 6 years from 2001 to 2007. Diabetologia 2009;52:2662-2664.
    • (2009) Diabetologia , vol.52 , pp. 2662-2664
    • Guilhem, I.1    Balkau, B.2    Lecordier, F.3
  • 29
    • 79960850769 scopus 로고    scopus 로고
    • Factors associated with increased risk of insulin pump discontinuation in pediatric patients with type 1 diabetes
    • de Vries L, Grushka Y, Lebenthal Y, Shalitin S, Phillip M. Factors associated with increased risk of insulin pump discontinuation in pediatric patients with type 1 diabetes. Pediatr Diabetes 2011;12:506-512.
    • (2011) Pediatr Diabetes , vol.12 , pp. 506-512
    • De Vries, L.1    Grushka, Y.2    Lebenthal, Y.3    Shalitin, S.4    Phillip, M.5
  • 30
    • 77954436411 scopus 로고    scopus 로고
    • Discontinuation of insulin pump treatment in children, adolescents, and young adults
    • DPVScience- Initiative and the German working group for insulin pump treatment in pediatric patients
    • Hofer SE, Heidtmann B, Raile K, et al.; DPVScience- Initiative and the German working group for insulin pump treatment in pediatric patients. Discontinuation of insulin pump treatment in children, adolescents, and young adults. A multicenter analysis based on the DPV database in Germany and Austria. Pediatr Diabetes 2010;11:116-121.
    • (2010) A Multicenter Analysis Based on the DPV Database in Germany and Austria. Pediatr Diabetes , vol.11 , pp. 116-121
    • Hofer, S.E.1    Heidtmann, B.2    Raile, K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.