1. Lachin JM, McGee PL, Greenbaum CJ, Palmer J, Pescovitz MD, Gottlieb P and Skyler J. Sample size requirements for studies of treatment effects on beta-cell function in newly diagnosed type 1 diabetes. PLoS One. 2011;6:e26471.
2. National Diabetes Data Group. Diabetes in America, Second edition.
3. National Diabetes Statistics Report. Centers for Diease Control, National Center for Cronic Disease Prevention and Health Promotion, Division of Diabetes Translation.
4. Maahs DM, West NA, Lawrence JM and Mayer-Davis EJ. Epidemiology of type 1 diabetes. Endocrinol Metab Clin North Am. 2010;39:481-497.
5. Imperatore G, Boyle JP, Thompson TJ, Case D, Dabelea D, Hamman RF, Lawrence JM, Liese AD, Liu LL, Mayer-Davis EJ, Rodriguez BL and Standiford D. Projections of type 1 and type 2 diabetes burden in the U.S. population aged <20 years through 2050: dynamic modeling of incidence, mortality, and population growth. Diabetes care. 2012;35:2515-2520.
6. Atkinson MA and Maclaren NK. The pathogenesis of insulin-dependent diabetes mellitus. N Engl J Med. 1994;331:1428-1436.
7. Harrison LC, Chu SX, DeAizpurua HJ, Graham M, Honeyman MC and Colman PG. Islet-reactive T cells are a marker of preclinical insulin-dependent diabetes. J Clin Invest. 1992;89:1161-1165.
8. Roep BO. The role of T-cells in the pathogenesis of Type 1 diabetes: from cause to cure. Diabetologia. 2003;46:305-321.
9. O'Meara NM, Sturis J, Herold KC, Ostrega DM and Polonsky KS. Alterations in the patterns of insulin secretion before and after diagnosis of IDDM. Diabetes care. 1995;18:568-571.
10. Eisenbarth GS, Srikanta S, Jackson R, Rabinowe S, Dolinar R, Aoki T and Morris MA. Anti-thymocyte globulin and prednisone immunotherapy of recent onset type 1 diabetes mellitus. Diabetes Res. 1985;2:271-6.
11. Herold KC, Gitelman SE, Masharani U, Hagopian W, Bisikirska B, Donaldson D, Rother K, Diamond B, Harlan DM and Bluestone JA. A single course of anti-CD3 monoclonal antibody hOKT3gamma1(Ala-Ala) results in improvement in C-peptide responses and clinical parameters for at least 2 years after onset of type 1 diabetes. Diabetes. 2005;54:1763-1769.
12. Palmer JP, Fleming GA, Greenbaum CJ, Herold KC, Jansa LD, Kolb H, Lachin JM, Polonsky KS, Pozzilli P and Skyler JS. C-Peptide Is the Appropriate Outcome Measure for Type 1 Diabetes Clinical Trials to Preserve β-Cell Function Report of an ADA Workshop, 21–22 October 2001. Diabetes. 2004;53:250-264.
13. Nathan DM, Zinman B, Cleary PA, Backlund J-YC, Genuth S, Miller R, Orchard TJ and Trial C. Modern-day clinical course of type 1 diabetes mellitus after 30 years’ duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005). Archives of Internal Medicine. 2009;169:1307.
14. Chatenoud L and Bluestone JA. CD3-specific antibodies: a portal to the treatment of autoimmunity. Nat Rev Immunol. 2007;7:622-632.
15. Herold KC, Gitelman SE, Ehlers MR, Gottlieb PA, Greenbaum CJ, Hagopian W, Boyle KD, Keyes-Elstein L, Aggarwal S, Phippard D, Sayre PH, McNamara J and Bluestone JA. Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders. Diabetes. 2013;62:3766-3774.
16. Couri CE, Oliveira MC, Stracieri AB, Moraes DA, Pieroni F, Barros GM, Madeira MIA, Malmegrim KC, Foss-Freitas MC and Simões BP. C-peptide levels and insulin independence following autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. Jama. 2009;301:1573-1579.
17. Salomon B and Bluestone JA. Complexities of CD28/B7: CTLA-4 costimulatory pathways in autoimmunity and transplantation. Annu Rev Immunol. 2001;19:225-252.
18. Salomon B, Lenschow DJ, Rhee L, Ashourian N, Singh B, Sharpe A and Bluestone JA. B7/CD28 costimulation is essential for the homeostasis of the CD4+CD25+ immunoregulatory T cells that control autoimmune diabetes. Immunity. 2000;12:431-440.
19. Bettini ML, Pan F, Bettini M, Finkelstein D, Rehg JE, Floess S, Bell BD, Ziegler SF, Huehn J, Pardoll DM and Vignali DAA. Loss of epigenetic modification driven by the Foxp3 transcription factor leads to regulatory T cell insufficiency. Immunity. 2012;36:717-730.
20. Tang Q, Adams JY, Penaranda C, Melli K, Piaggio E, Sgouroudis E, Piccirillo CA, Salomon BL and Bluestone JA. Central role of defective interleukin-2 production in the triggering of islet autoimmune destruction. Immunity. 2008;28:687-697.
21. D'Alise AM, Ergun A, Hill JA, Mathis D and Benoist C. A cluster of coregulated genes determines TGF-beta-induced regulatory T-cell (Treg) dysfunction in NOD mice. Proc Natl Acad Sci U S A. 2011;108:8737-8742.
22. Grinberg-Bleyer Y, Baeyens A, You S, Elhage R, Fourcade G, Gregoire S, Cagnard N, Carpentier W, Tang Q, Bluestone J, Chatenoud L, Klatzmann D, Salomon BL and Piaggio E. IL-2 reverses established type 1 diabetes in NOD mice by a local effect on pancreatic regulatory T cells. J Exp Med. 2010;207:1871-1878.
23. Tang Q, Henriksen KJ, Bi M, Finger EB, Szot G, Ye J, Masteller EL, McDevitt H, Bonyhadi M and Bluestone JA. In vitro-expanded antigen-specific regulatory T cells suppress autoimmune diabetes. J Exp Med. 2004;199:1455-1465.
24. Marek-Trzonkowska N, Myśliwiec M, Dobyszuk A, Grabowska M, Derkowska I, Juścińska J, Owczuk R, Szadkowska A, Witkowski P and Młynarski W. Therapy of type 1 diabetes with CD4(+)CD25(high)CD127-regulatory T cells prolongs survival of pancreatic islets - results of one year follow-up. Clinical Immunology. 2014;153:23-30.
25. Marek-Trzonkowska N, Mysliwiec M, Dobyszuk A, Grabowska M, Techmanska I, Juscinska J, Wujtewicz MA, Witkowski P, Mlynarski W, Balcerska A, Mysliwska J and Trzonkowski P. Administration of CD4+CD25highCD127- regulatory T cells preserves beta-cell function in type 1 diabetes in children. Diabetes care. 2012;35:1817-20.
26. Trzonkowski P, Bieniaszewska M, Juscinska J, Dobyszuk A, Krzystyniak A, Marek N, Mysliwska J and Hellmann A. First-in-man clinical results of the treatment of patients with graft versus host disease with human ex vivo expanded CD4+CD25+CD127- T regulatory cells. Clin Immunol. 2009;133:22-26.
27. Bluestone JA, Buckner JH, Fitch M, Gitelman SE, Gupta S, Hellerstein MK, Herold KC, Lares A, Lee MR, Li K, Liu W, Long SA, Masiello LM, Nguyen V, Putnam AL, Rieck M, Sayre PH and Tang Q. Type 1 diabetes immunotherapy using polyclonal regulatory T cells. Sci Transl Med. 2015;7:315ra189.
28. Tang Q and Lee K. Regulatory T-cell therapy for transplantation: how many cells do we need? Curr Opin Organ Transplant. 2012;17:349-354.
29. Dabelea D, Bell RA, D'Agostino RB, Imperatore G, Johansen JM, Linder B, Liu LL, Loots B, Marcovina S, Mayer-Davis EJ, Pettitt DJ and Waitzfelder B. Incidence of diabetes in youth in the United States. JAMA. 2007;297:2716-2724.
30. Harjutsalo V, Sjoberg L and Tuomilehto J. Time trends in the incidence of type 1 diabetes in Finnish children: a cohort study. Lancet. 2008;371:1777-1782.
31. DIAMOND_Project_Group. Incidence and trends of childhood Type 1 diabetes worldwide 1990-1999. Diabet Med. 2006;23:857-66.
32. Eurodiab A. Variation and trends in incidence of childhood diabetes in Europe. Lancet. 2000;355:873-876.
33. Haller MJ, Atkinson MA and Schatz D. Type 1 diabetes mellitus: etiology, presentation, and management. Pediatric Clinics of North America. 2005;52:1553-1578.
34. Bluestone JA, Herold K and Eisenbarth G. Genetics, pathogenesis and clinical interventions in type 1 diabetes. Nature. 2010;464:1293-1300.
35. Leslie RDG, Williams R and Pozzilli P. Clinical review: Type 1 diabetes and latent autoimmune diabetes in adults: one end of the rainbow. J Clin Endocrinol Metab. 2006;91:1654-1659.
36. Greenbaum CJ, Beam CA, Boulware D, Gitelman SE, Gottlieb PA, Herold KC, Lachin JM, McGee P, Palmer JP, Pescovitz MD, Krause-Steinrauf H, Skyler JS and Sosenko JM. Fall in C-peptide during first 2 years from diagnosis: evidence of at least two distinct phases from composite Type 1 Diabetes TrialNet data. Diabetes. 2012;61:2066-2073.
37. Pescovitz MD, Greenbaum CJ, Krause-Steinrauf H, Becker DJ, Gitelman SE, Goland R, Gottlieb PA, Marks JB, McGee PF, Moran AM, Raskin P, Rodriguez H, Schatz DA, Wherrett D, Wilson DM, Lachin JM and Skyler JS. Rituximab, B-lymphocyte depletion, and preservation of beta-cell function. N Engl J Med. 2009;361:2143-2152.
38. Sherry N, Hagopian W, Ludvigsson J, Jain SM, Wahlen J, Ferry RJ, Bode B, Aronoff S, Holland C, Carlin D, King KL, Wilder RL, Pillemer S, Bonvini E, Johnson S, Stein KE, Koenig S, Herold KC and Daifotis AG. Teplizumab for treatment of type 1 diabetes (Protege study): 1-year results from a randomised, placebo-controlled trial. Lancet. 2011;378:487-497.
39. American_Diabetes_Association. Standards of Medical Care in Diabetes. Chapter 12. Children and Adolescents. Diabetes care. 2017;40:S105-s113.
40. Silverstein J, Klingensmith G, Copeland K, Plotnick L, Kaufman F, Laffel L, Deeb L, Grey M, Anderson B, Holzmeister LA and Clark N. Care of children and adolescents with type 1 diabetes: a statement of the American Diabetes Association. Diabetes Care. 2005;28:186-212.
41. American_Diabetes_Association. Standards of Medical Care in Diabetes. Chapter 2. Classification and Diagnosis of Diabetes. Diabetes care. 2017;40:S11-s24.
42. The US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Published May 28, 2009 (Version 4.03, June 14, 2010). 2010.
43. Bugelski PJ, Volk A, Walker MR, Krayer JH, Martin P and Descotes J. Critical review of preclinical approaches to evaluate the potential of immunosuppressive drugs to influence human neoplasia. International journal of toxicology. 2010;29:435-466.
44. Corthay A. Does the immune system naturally protect against cancer? Frontiers in immunology. 2014;5.
45. Grulich AE, van Leeuwen MT, Falster MO and Vajdic CM. Incidence of cancers in people with HIV/AIDS compared with immunosuppressed transplant recipients: a meta-analysis. The Lancet. 2007;370:59-67.