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Volumn 39, Issue 7, 2016, Pages 1230-1240

Phase 3 trial of transplantation of human islets in type 1 diabetes complicated by severe hypoglycemia

(25)  Hering, Bernhard J a   Clarke, William R b   Bridges, Nancy D c   Eggerman, Thomas L d   Alejandro, Rodolfo e   Bellin, Melena D a   Chaloner, Kathryn b   Czarniecki, Christine W c   Goldstein, Julia S c   Hunsicker, Lawrence G b   Kaufman, Dixon B f   Korsgren, Olle g   Larsen, Christian P h   Luo, Xunrong i   Markmann, James F j   Naji, Ali k   Oberholzer, Jose l   Posselt, Andrew M m   Rickels, Michael R k   Ricordi, Camillo e   more..


Author keywords

[No Author keywords available]

Indexed keywords

BASILIXIMAB; C PEPTIDE; HEMOGLOBIN A1C; RAPAMYCIN; TACROLIMUS; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN;

EID: 84975832571     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc15-1988     Document Type: Article
Times cited : (494)

References (40)
  • 1
    • 84903156652 scopus 로고    scopus 로고
    • Glycemic goals in diabetes: Tradeoff between glycemic control and iatrogenic hy-poglycemia
    • Cryer PE. Glycemic goals in diabetes: tradeoff between glycemic control and iatrogenic hy-poglycemia. Diabetes 2014;63:2188-2195
    • (2014) Diabetes , vol.63 , pp. 2188-2195
    • Cryer, P.E.1
  • 2
    • 84876796916 scopus 로고    scopus 로고
    • Hy-poglycemia and diabetes: A report of a workgroup of the American Diabetes Association and the Endocrine Society
    • Seaquist ER, Anderson J, Childs B, et al. Hy-poglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 2013;36:1384-1395
    • (2013) Diabetes Care , vol.36 , pp. 1384-1395
    • Seaquist, E.R.1    Anderson, J.2    Childs, B.3
  • 3
    • 41749114957 scopus 로고    scopus 로고
    • Prevalence of impaired awareness of hypo-glycaemia in adults with type 1 diabetes
    • Geddes J, Schopman JE, Zammitt NN, Frier BM. Prevalence of impaired awareness of hypo-glycaemia in adults with type 1 diabetes. Diabet Med 2008;25:501-504
    • (2008) Diabet Med , vol.25 , pp. 501-504
    • Geddes, J.1    Schopman, J.E.2    Zammitt, N.N.3    Frier, B.M.4
  • 4
    • 84864380622 scopus 로고    scopus 로고
    • Improved biomedical and psychological outcomes 1 year after structured education in flexible insulin therapy for people with type 1 diabetes: The U.K. DAFNE experience
    • Hopkins D, Lawrence I, Mansell P, et al. Improved biomedical and psychological outcomes 1 year after structured education in flexible insulin therapy for people with type 1 diabetes: the U.K. DAFNE experience.Diabetes Care 2012; 35:1638-1642
    • (2012) Diabetes Care , vol.35 , pp. 1638-1642
    • Hopkins, D.1    Lawrence, I.2    Mansell, P.3
  • 5
    • 84881505727 scopus 로고    scopus 로고
    • Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: Results from the T1D Exchange clinic registry
    • Weinstock RS, Xing D, Maahs DM, et al.; T1D Exchange Clinic Network. Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: results from the T1D Exchange clinic registry. J Clin Endocrinol Metab 2013;98:3411-3419
    • (2013) J Clin Endocrinol Metab , vol.98 , pp. 3411-3419
    • Weinstock, R.S.1    Xing, D.2    Maahs, D.M.3
  • 6
    • 84927178554 scopus 로고    scopus 로고
    • Hypoglycaemia in diabetes melli-tus: Epidemiology and clinical implications
    • Frier BM. Hypoglycaemia in diabetes melli-tus: epidemiology and clinical implications. Nat Rev Endocrinol 2014;10:711-722
    • (2014) Nat Rev Endocrinol , vol.10 , pp. 711-722
    • Frier, B.M.1
  • 7
    • 84962438836 scopus 로고    scopus 로고
    • Evidence-informed clinical practice recommendations for treatment of type 1 diabetes complicated by problematic hypoglycemia
    • Choudhary P, Rickels MR, Senior PA, et al. Evidence-informed clinical practice recommendations for treatment of type 1 diabetes complicated by problematic hypoglycemia. Diabetes Care 2015;38:1016-1029
    • (2015) Diabetes Care , vol.38 , pp. 1016-1029
    • Choudhary, P.1    Rickels, M.R.2    Senior, P.A.3
  • 8
    • 84962388459 scopus 로고    scopus 로고
    • Interventions that restore awareness of hypoglycemia in adults with type 1 diabetes: A systematic review and meta-analysis
    • Yeoh E, Choudhary P, Nwokolo M, Ayis S, Amiel SA. Interventions that restore awareness of hypoglycemia in adults with type 1 diabetes: a systematic review and meta-analysis. Diabetes Care 2015;38:1592-1609
    • (2015) Diabetes Care , vol.38 , pp. 1592-1609
    • Yeoh, E.1    Choudhary, P.2    Nwokolo, M.3    Ayis, S.4    Amiel, S.A.5
  • 9
    • 84855185039 scopus 로고    scopus 로고
    • Standards of medical care in diabetes-2012
    • American Diabetes Association. Standards of medical care in diabetes-2012. Diabetes Care 2012;35(Suppl. 1):S11-S63
    • (2012) Diabetes Care , vol.35 , pp. S11-S63
  • 10
    • 84909954089 scopus 로고    scopus 로고
    • Outcomes for adults with type 1 diabetes referred with severe hypoglycaemia and/or referred for islet transplantation to a specialist hypoglycaemia service
    • Byrne ML, Hopkins D, Littlejohn W, et al. Outcomes for adults with type 1 diabetes referred with severe hypoglycaemia and/or referred for islet transplantation to a specialist hypoglycaemia service. Horm Metab Res 2015; 47:9-15
    • (2015) Horm Metab Res , vol.47 , pp. 9-15
    • Byrne, M.L.1    Hopkins, D.2    Littlejohn, W.3
  • 11
    • 84942755473 scopus 로고    scopus 로고
    • Current state of type 1 diabetes treatment in the U.S.: Updated data from the T1D Exchange clinic registry
    • Miller KM, Foster NC, Beck RW, et al.; T1D Exchange ClinicNetwork. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care 2015;38:971-978
    • (2015) Diabetes Care , vol.38 , pp. 971-978
    • Miller, K.M.1    Foster, N.C.2    Beck, R.W.3
  • 12
    • 0034721255 scopus 로고    scopus 로고
    • Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free im-munosuppressive regimen
    • Shapiro AM, Lakey JR, Ryan EA, et al. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free im-munosuppressive regimen. N Engl J Med 2000; 343:230-238
    • (2000) N Engl J Med , vol.343 , pp. 230-238
    • Shapiro, A.M.1    Lakey, J.R.2    Ryan, E.A.3
  • 13
    • 13844265752 scopus 로고    scopus 로고
    • Single-donor, marginal-dose islet transplantation in patients with type 1 diabetes
    • Hering BJ, Kandaswamy R, Ansite JD, et al. Single-donor, marginal-dose islet transplantation in patients with type 1 diabetes. JAMA 2005;293:830-835
    • (2005) JAMA , vol.293 , pp. 830-835
    • Hering, B.J.1    Kandaswamy, R.2    Ansite, J.D.3
  • 14
    • 33749070784 scopus 로고    scopus 로고
    • International trial of the Edmonton protocol for islet transplantation
    • Shapiro AM, Ricordi C, Hering BJ, et al. International trial of the Edmonton protocol for islet transplantation. N Engl J Med 2006;355: 1318-1330
    • (2006) N Engl J Med , vol.355 , pp. 1318-1330
    • Shapiro, A.M.1    Ricordi, C.2    Hering, B.J.3
  • 15
    • 84975790050 scopus 로고    scopus 로고
    • Food and Drug Administration Center for Biologics Evaluation and Research. Biological Response Modifiers Advisory Committee (BRMAC) meeting 36 [article online], 2003 Accessed 20 October 2015
    • Food and Drug Administration Center for Biologics Evaluation and Research. Biological Response Modifiers Advisory Committee (BRMAC) meeting 36 [article online], 2003. Available from http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3986T1.htm. Accessed 20 October 2015
  • 16
    • 84975787285 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products [article online], 2009 Accessed 20 October 2015
    • U.S. Food and Drug Administration. Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products [article online], 2009. Available from http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm182440.htm. Accessed 20 October 2015
  • 17
    • 40249120466 scopus 로고    scopus 로고
    • Standards of medical care in diabetesd2008
    • American Diabetes Association. Standards of medical care in diabetesd2008. Diabetes Care 2008;31(Suppl. 1):S12-S54
    • (2008) Diabetes Care , vol.31 , pp. S12-S54
  • 18
    • 77649091668 scopus 로고    scopus 로고
    • American Association of Clinical Endocrinologists medical guidelines for clinical practice for the managementofdiabetes mellitus
    • Rodbard HW, Blonde L, Braithwaite SS, et al.; AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the managementofdiabetes mellitus. Endocr Pract 2007;13(Suppl. 1):1-68
    • (2007) Endocr Pract , vol.13 , pp. 1-68
    • Rodbard, H.W.1    Blonde, L.2    Braithwaite, S.S.3
  • 19
    • 1842527586 scopus 로고    scopus 로고
    • Assessment of the severity of hypoglycemia and glycemic lability in type 1 diabetic subjects undergoing islet transplantation
    • Ryan EA, Shandro T, Green K, et al. Assessment of the severity of hypoglycemia and glycemic lability in type 1 diabetic subjects undergoing islet transplantation. Diabetes 2004;53:955-962
    • (2004) Diabetes , vol.53 , pp. 955-962
    • Ryan, E.A.1    Shandro, T.2    Green, K.3
  • 20
    • 0028958816 scopus 로고
    • Reduced awareness of hypoglycemia in adults with IDDM. A prospective study of hypoglycemic frequency and associated symptoms
    • Clarke WL, Cox DJ, Gonder-Frederick LA, Julian D, Schlundt D, Polonsky W. Reduced awareness of hypoglycemia in adults with IDDM. A prospective study of hypoglycemic frequency and associated symptoms. Diabetes Care 1995;18:517-522
    • (1995) Diabetes Care , vol.18 , pp. 517-522
    • Clarke, W.L.1    Cox, D.J.2    Gonder-Frederick, L.A.3    Julian, D.4    Schlundt, D.5    Polonsky, W.6
  • 21
    • 84975865783 scopus 로고    scopus 로고
    • The NIH CIT Consortium Chemistry Manufacturing Controls Monitoring Committee. Purified human pancreatic islets (PHPI) master production batch recordda standard operating procedure of the NIH Clinical Islet Transplantation Consortium [article online], 2014 Accessed 20 October 2015
    • The NIH CIT Consortium Chemistry Manufacturing Controls Monitoring Committee. Purified human pancreatic islets (PHPI) master production batch recordda standard operating procedure of the NIH Clinical Islet Transplantation Consortium [article online], 2014. Available from http://www.cellr4.org/wp-content/uploads/2014/04/CellR4-CIT-Master-Batch-Record-SOP-Title-page.pdf. Accessed 20 October 2015
  • 22
    • 84879553051 scopus 로고    scopus 로고
    • Multicenter Australian trial of islet transplantation: Improving accessibility and outcomes
    • O'Connell PJ, Holmes-Walker DJ, Goodman D, et al.; Australian Islet Transplant Consortium. Multicenter Australian trial of islet transplantation: improving accessibility and outcomes. Am J Transplant 2013;13:1850-1858
    • (2013) Am J Transplant , vol.13 , pp. 1850-1858
    • O'Connell, P.J.1    Holmes-Walker, D.J.2    Goodman, D.3
  • 23
    • 84888344174 scopus 로고    scopus 로고
    • Attainment of metabolic goals in the integrated UK islet transplant program with locally isolated and transported preparations
    • Brooks AM, Walker N, Aldibbiat A, et al. Attainment of metabolic goals in the integrated UK islet transplant program with locally isolated and transported preparations. Am J Transplant 2013;13:3236-3243
    • (2013) Am J Transplant , vol.13 , pp. 3236-3243
    • Brooks, A.M.1    Walker, N.2    Aldibbiat, A.3
  • 24
    • 84862521903 scopus 로고    scopus 로고
    • HLA class i sensitization in islet transplant recipients: Report from the Collaborative Islet Transplant Registry
    • Naziruddin B, Wease S, Stablein D, et al. HLA class I sensitization in islet transplant recipients: report from the Collaborative Islet Transplant Registry. Cell Transplant 2012;21: 901-908
    • (2012) Cell Transplant , vol.21 , pp. 901-908
    • Naziruddin, B.1    Wease, S.2    Stablein, D.3
  • 25
    • 84879141468 scopus 로고    scopus 로고
    • 2012 annual literature review of donor-specific HLA antibodies after organ transplantation
    • Kaneku H. 2012 annual literature review of donor-specific HLA antibodies after organ transplantation. Clin Transpl 2012;207-217
    • (2012) Clin Transpl , pp. 207-217
    • Kaneku, H.1
  • 26
  • 27
    • 0025602096 scopus 로고
    • Gluca-gon catecholamine and pancreatic polypeptide secretion in type i diabetic recipients of pancreas allografts
    • Diem P, Redmon JB, Abid M, et al. Gluca-gon, catecholamine and pancreatic polypeptide secretion in type I diabetic recipients of pancreas allografts. J Clin Invest 1990;86:2008-2013
    • (1990) J Clin Invest , vol.86 , pp. 2008-2013
    • Diem, P.1    Redmon, J.B.2    Abid, M.3
  • 28
    • 0030904145 scopus 로고    scopus 로고
    • Pancreas transplantation restores epinephrine response and symptom recognition during hypoglycemia in patients with long-standing type i diabetes and autonomic neuropathy
    • Kendall DM, Rooney DP, Smets YF, Salazar Bolding L, Robertson RP. Pancreas transplantation restores epinephrine response and symptom recognition during hypoglycemia in patients with long-standing type I diabetes and autonomic neuropathy. Diabetes 1997;46:249-257
    • (1997) Diabetes , vol.46 , pp. 249-257
    • Kendall, D.M.1    Rooney, D.P.2    Smets, Y.F.3    Salazar Bolding, L.4    Robertson, R.P.5
  • 30
    • 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, Lim EM, 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    Lim, E.M.4    Davis, E.A.5    Jones, T.W.6
  • 31
    • 84880274350 scopus 로고    scopus 로고
    • Threshold-based insulin-pump interruption for reduction of hy-poglycemia
    • Bergenstal RM, Klonoff DC, Garg SK, et al.; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hy-poglycemia. 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
  • 32
    • 84868112851 scopus 로고    scopus 로고
    • Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: A systematic review and meta-analysis
    • Yeh HC, Brown TT, Maruthur N, et al. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med 2012;157:336-347
    • (2012) Ann Intern Med , vol.157 , pp. 336-347
    • Yeh, H.C.1    Brown, T.T.2    Maruthur, N.3
  • 33
    • 0028608981 scopus 로고
    • Reversal of hypoglycemia unawareness, but not defective glucose counterregulation, in IDDM
    • Dagogo-Jack S, Rattarasarn C, Cryer PE. Reversal of hypoglycemia unawareness, but not defective glucose counterregulation, in IDDM. Diabetes 1994;43:1426-1434
    • (1994) Diabetes , vol.43 , pp. 1426-1434
    • Dagogo-Jack, S.1    Rattarasarn, C.2    Cryer, P.E.3
  • 34
    • 0028237872 scopus 로고
    • Restoration of hypoglycaemia awareness in patients with long-duration insulin-dependent diabetes
    • Cranston I, Lomas J, Maran A, Macdonald I, Amiel SA. Restoration of hypoglycaemia awareness in patients with long-duration insulin-dependent diabetes. Lancet 1994;344:283-287
    • (1994) Lancet , vol.344 , pp. 283-287
    • Cranston, I.1    Lomas, J.2    Maran, A.3    MacDonald, I.4    Amiel, S.A.5
  • 35
    • 0027444659 scopus 로고
    • Me-ticulous prevention of hypoglycemia normalizes the glycemic thresholds and magnitude of most of neuroendocrine responses to, symptoms of, and cognitive function during hypoglyce-mia in intensively treated patients with short-term IDDM
    • Fanelli CG, Epifano L, Rambotti AM, et al. Me-ticulous prevention of hypoglycemia normalizes the glycemic thresholds and magnitude of most of neuroendocrine responses to, symptoms of, and cognitive function during hypoglyce-mia in intensively treated patients with short-term IDDM. Diabetes 1993;42:1683-1689
    • (1993) Diabetes , vol.42 , pp. 1683-1689
    • Fanelli, C.G.1    Epifano, L.2    Rambotti, A.M.3
  • 36
    • 84904963066 scopus 로고    scopus 로고
    • Recovery of hypoglycemia awareness in longstanding type 1 diabetes: A multicenter 2 3 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS)
    • Little SA, Leelarathna L, Walkinshaw E, et al. Recovery of hypoglycemia awareness in longstanding type 1 diabetes: a multicenter 2 3 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS). Diabetes Care 2014;37:2114-2122
    • (2014) Diabetes Care , vol.37 , pp. 2114-2122
    • Little, S.A.1    Leelarathna, L.2    Walkinshaw, E.3
  • 37
    • 84896714687 scopus 로고    scopus 로고
    • A psy-choeducational program to restore hypoglycemia awareness: The DAFNE-HART pilot study
    • de Zoysa N, Rogers H, Stadler M, et al. A psy-choeducational program to restore hypoglycemia awareness: the DAFNE-HART pilot study. Diabetes Care 2014;37:863-866
    • (2014) Diabetes Care , vol.37 , pp. 863-866
    • De Zoysa, N.1    Rogers, H.2    Stadler, M.3
  • 38
    • 84899114951 scopus 로고    scopus 로고
    • Frequency of morning keto-sis after overnight insulin suspension using an automated nocturnal predictive low glucose suspend system
    • Beck RW, Raghinaru D, Wadwa RP, Chase HP, Maahs DM, Buckingham BA; In Home Closed Loop Study Group. Frequency of morning keto-sis after overnight insulin suspension using an automated nocturnal predictive low glucose suspend system. Diabetes Care 2014;37:1224-1229
    • (2014) Diabetes Care , vol.37 , pp. 1224-1229
    • Beck, R.W.1    Raghinaru, D.2    Wadwa, R.P.3    Chase, H.P.4    Maahs, D.M.5    Buckingham, B.A.6
  • 39
    • 84926287781 scopus 로고    scopus 로고
    • Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: An open-label randomised controlled crossover trial
    • Haidar A, Legault L, Messier V, Mitre TM, Leroux C, Rabasa-Lhoret R. Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: an open-label randomised controlled crossover trial. Lancet Diabetes Endocri-nol 2015;3:17-26
    • (2015) Lancet Diabetes Endocri-nol , vol.3 , pp. 17-26
    • Haidar, A.1    Legault, L.2    Messier, V.3    Mitre, T.M.4    Leroux, C.5    Rabasa-Lhoret, R.6
  • 40
    • 84958036791 scopus 로고    scopus 로고
    • Reportfrom IPITA-TTS opinion leaders meeting on the future of beta-cell replacement
    • Bartlett ST, Markmann JF, Johnson P, et al. Reportfrom IPITA-TTS opinion leaders meeting on the future of beta-cell replacement. Transplantation 2016;100(Suppl. 2):S1-S44
    • (2016) Transplantation , vol.100 , pp. S1-S44
    • Bartlett, S.T.1    Markmann, J.F.2    Johnson, P.3


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