TrialNet and DPT-1 Published Manuscripts - Rev. 09/11/17

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1 TrialNet and DPT-1 Published Manuscripts - Rev. 09/11/ ) * DPT-1 Study Group. The Diabetes Prevention Trial-Type 1 diabetes (DPT-1): Implementation of screening and staging of relatives. Transplant Proc 1995; 27(6):3377. PMID ) * Greenbaum CJ, Schatz DA, Cuthbertson D, Zeidler A, Eisenbarth GS, Krischer JP. Islet Cell Antibody-Positive Relatives With Human Leukocyte Antigen DQA1*0102, DQB1*0602: Identification by the Diabetes Prevention Trial-Type 1. J Clin Endocrinol Metab 2000; 85(3): PMID ) * Chase HP, Cuthbertson DD, Dolan LM, Kaufman F, Krischer JP, Schatz DA, White NH, Wilson DM, Wolfsdorf J, and the Diabetes Prevention Trial - Type 1 Study Group. Firstphase Insulin Release During the Intravenous Glucose Tolerance Test as a Risk Factor for Type 1 Diabetes. J Pediatr 2001; 138: ) * Greenbaum CJ, Cuthbertson D, Krischer JP, and the Diabetes Prevention Trial of Type 1 Diabetes Study Group. Type 1 Diabetes Manifested Solely by 2-h Oral Glucose Tolerance Test Criteria. Diabetes 2001; 50(2): PMID ) * Yu L, Cuthbertson DD, Maclaren N, Jackson R, Palmer JP, Orban T, Eisenbarth GS, Krischer JP, DPT-1 Participating Investigators. Expression of GAD65 and Islet Cell Antibody (ICA512) Autoantibodies Among Cytoplasmic ICA+ Relatives Is Associated With Eligibility for the Diabetes Prevention Trial-Type 1. Diabetes 2001; 50(8): PMID ) * Yu L, Cuthbertson DD, Eisenbarth GS, Krischer JP, DPT1 Participating Investigators. Diabetes Prevention Trial 1: Prevalence of GAD and ICA512 (IA-2) Autoantibodies by Relationship to Proband. Ann N Y Acad Sci 2002; 958: PMID ) * Diabetes Prevention Trial - Type 1 Diabetes Study Group. Effects of Insulin in Relatives of Patients with Type 1 Diabetes Mellitus. N Engl J Med 2002; 346(22): PMID ) * Krischer JP, Cuthbertson DD, Yu L, Orban T, Maclaren N, Jackson R, Winter WE, Schatz DA, Palmer JP, Eisenbarth GS, and the Diabetes Prevention Trial - Type 1 Study Group. Screening Strategies for the Identification of Multiple Antibody Positive Relatives of Individuals with Type 1 Diabetes. J Clin Endocrinol Metab 2003; 88(1): PMID ) Palmer JP, Fleming GA, Greenbaum CJ, Herold KC, Jansa LD, Kolb H, Lachin JM, Polonsky KS, Pozzilli P, Skyler JS, Steffes MW. C-Peptide is the Appropriate Outcome Measure for Type 1 Diabetes Clinical Trials to Preserve Beta-Cell Function: Report of an ADA Workshop. Diabetes 2004; 53(1): PMID ) Lachin JM. The Role of Measurement Reliability in Clinical Trials. Clin Trials 2004; 1(6): PMID Page 1 of 15

2 11) * Krischer JP, Cuthbertson DD, Greenbaum C, Diabetes Prevention Trial-Type 1 Study Group. Male Sex Increases the Risk of Autoimmunity But Not Type 1 Diabetes. Diabetes Care 2004; 27(8): PMID ) * Redondo MJ, Fain PR, Krischer JP, Yu L, Cuthbertson D, Winter WE, Eisenbarth GS, DPT-1 Study Group. Expression of Beta-Cell Autoimmunity Does Not Differ Between Potential Dizygotic Twins and Siblings of Patients with Type 1 Diabetes. J Autoimmun 2004; 23(3): PMID ) Lachin JM. Maximum Information Designs. Clin Trials 2005; 2(5): PMID ) * Diabetes Prevention Trial - Type 1 Diabetes Study Group. Effects of Oral Insulin in Relatives of Patients with Type 1 Diabetes Mellitus. Diabetes Care 2005; 28: ) * Greenbaum CJ, Eisenbarth G, Atkinson M, Yu L, Babu S, Schatz D, Zeidler A, Orban T, Wasserfall C, Cuthbertson D, Krischer J, DPT-1 Study Group. High Frequency of Abnormal Glucose Tolerance in DQA1*0102/DQB1*0602 Relatives Identified as Part of the Diabetes Prevention Trial Type 1 Diabetes. Diabetologia 2005; 48: ) * Rhodes ET, Wolfsdorf JI, Cuthbertson DD, Feldman HA, Ludwig DS, Diabetes Prevention Trial -Type 1 Study Group. Effect of Low-Dose Insulin Treatment on Body Weight and Physical Development in Children and Adolescents at Risk for Type 1 Diabetes. Diabetes Care 2005; 28(8): PMID ) Lachin JM. A Review of Methods for Futility Stopping Based on Conditional Power. Stat Med 2005; 24(18): PMID ) * Sosenko JM, Palmer JP, Greenbaum CJ, Mahon J, Cowie C, Krischer JP, Chase HP, White NH, Buckingham B, Herold KC, Cuthbertson D, Skyler JS, and the Diabetes Prevention Trial-1 Study Group. Patterns of Metabolic Progression to Type 1 Diabetes in the Diabetes Prevention Trial Type 1. Diabetes Care 2006; 29: ) * Tsai EB, Sherry NA, Palmer JP, Herold KC, and the DPT-1 Group. The Rise and Fall of Insulin Secretion in Type 1 Diabetes Mellitus. Diabetologia 2006; 49(2): PMID ) * Redondo MJ, Babu S, Zeidler A, Orban T, Yu L, Greenbaum C, Palmer JP, Cuthbertson D, Eisenbarth GS, Krischer JP, Schatz D, DPT-1 Study Group. Specific HLA DQ Influence on Expression of Anti-Islet Autoantibodies and Progression to Type 1 Diabetes. J Clin Endocrinol Metab 2006; 91(5): PMID ) Lachin JM. Operating Characteristics of Sample Size Re-estimation with Futility Stopping Based on Conditional Power. Stat Med 2006; 25(19): PMID ) * Barker JM, McFann K, Harrison LC, Fourlanos S, Krischer JP, Cuthbertson D, Chase HP, Eisenbarth GS, DPT-1 Study Group. Pre-Type 1 Diabetes Dysmetabolism: Maximal sensitivity achieved with both Oral and Intravenous Glucose Tolerance Testing. J Pediatr 2007; 150(1): e6. PMID , PMCID PMC ) * Sosenko JM, Palmer JP, Greenbaum CJ, Mahon J, Cowie C, Krischer JP, Chase HP, White NH, Buckingham B, Herold KC, Cuthbertson D, Skyler JS, and the Diabetes Prevention Trial-1 Study Group. Increasing the Accuracy of Oral Glucose Tolerance Testing and Extending its Application to Individuals with Normal Glucose Tolerance for the Page 2 of 15

3 Prediction of Type 1 Diabetes: the Diabetes Prevention Trial- Type 1. Diabetes Care 2007; 30(1): PMID ) * Barker JM, McFann KK, Orban T, on behalf of the DPT-1 Study Group. Effect of Oral Insulin on Insulin Autoantibody Levels in the Diabetes Prevention Trial Type 1 Oral Insulin Study. Diabetologia 2007; 50: ) * Xu P, Cuthbertson D, Greenbaum C, Palmer JP, Krischer JP, and Diabetes Prevention Trial-Type 1 Study Group. The Role of Insulin Resistance in Predicting the Progression to Type 1 Diabetes. Diabetes Care 2007; 30: ) * Johnson SB, Baughcum AE, Hood K, Rafkin-Mervis LE, Schatz DA, for the DPT-1 Study Group. Participant and Parent Experiences in the Parenteral Insulin Arm of the Diabetes Prevention Trial for Type 1 Diabetes. Diabetes Care 2007; 30: ) Lachin JM, Younes N. A Composite Design for Transition from a Preliminary to a Full-Scale Study. Stat Med 2007; 26: ) * Sosenko JM, Krischer JP, Palmer JP, Mahon J, Cowie C, Greenbaum CJ, Cuthbertson D, Lachin JM, Skyler JS, and the Diabetes Prevention Trial-1 Study Group. A Risk Score for Type 1 Diabetes Derived from Autoantibody Positive Participants in The Diabetes Prevention Trial-Type 1. Diabetes Care 2008; 31: PMID ) * Sherr J, Sosenko J, Skyler JS, Herold K. Prevention of Type 1 diabetes. The Time Has Come. Nat Clin Pract Endocrinol Metab 2008; 4: (Review). PMID ) * Sosenko JM, Palmer JP, Rafkin-Mervis L, Krischer JP, Cuthbertson D, Matheson D, Skyler JS, and the DPT-1 Study Group. Glucose and C-peptide Changes in the Perionset Period of Type 1 Diabetes in the Diabetes Prevention Trial-Type 1. Diabetes Care 2008; 31: PMID , PMCID PMC ) Skyler JS, and the Type 1 Diabetes TrialNet Study Group. Update on Worldwide Efforts to Prevent Type 1 Diabetes. Ann N Y Acad Sci 2008; 1150: PMID , PMCID PMC , NIHMS NIHMS ) Skyler JS, Greenbaum CJ, Lachin JM, Leschek E, Rafkin-Mervis L, Savage P, Spain L, and the Type 1 Diabetes TrialNet Study Group. Type 1 Diabetes TrialNet An International Collaborative Clinical Trials Network. Ann N Y Acad Sci 2008; 1150: PMID , PMCID PMC , NIHMS NIHMS ) Greenbaum CJ, Mandrup-Poulsen T, Friedenberg-McGee P, Battelino T, Haastert B, Ludvigsson J, Pozzilli P, Lachin JM, Kolb H, and The Type 1 Diabetes TrialNet Research Group, and The European C-peptide Trial Study Group. Mixed-Meal Tolerance Test Versus Glucagon Stimulation Test for the Assessment of B-Cell Function in Therapeutic Trials in Type 1 Diabetes. Diabetes Care 2008; 31: PMID , PMCID PMC ) * Butty V, Campbell C, Mathis D, Benoist C, and the Diabetes Prevention Trial-Type 1 Study Group. Impact of diabetes susceptibility loci on progression from pre-diabetes to diabetes in at-risk individuals of the DPT1 trial. Diabetes 2008; 57(8): PMID , PMCID PMC ) Mahon J, Sosenko JM, Rafkin-Mervis L, Krause-Steinrauf H, Lachin JM, Thompson C, Bingley PJ, Bonifacio E, Palmer JP, Eisenbarth GS, Wolfsdorf J, Skyler JS, for the TrialNet Natural History Committee, and Type 1 Diabetes TrialNet Study Group. The TrialNet Page 3 of 15

4 Natural History Study of the Development of Type 1 Diabetes: Objectives, Design, and Initial Results. Pediatr Diabetes 2009; 10: PMID ) * Johnson SB, Baughcum AE, Rafkin-Mervis LE, Schatz DA, for the DPT-1 Study Group. Participant and Parent Experiences in the Oral Insulin Study of the Diabetes Prevention Trial for Type 1 Diabetes. Pediatr Diabetes 2009; 10: PMID , PMCID PMC ) * Triolo TM, Chase HP, Barker JM, for the DPT-1 Study Group. Diabetic subjects diagnosed through the Diabetes Prevention Trial-Type 1 (DPT-1) are often asymptomatic with normal A1C at diabetes onset. Diabetes Care 2009; 32: PMID , PMCID PMC ) * Sosenko JM, Palmer JP, Rafkin-Mervis L, Krischer JP, Cuthbertson D, Mahon J, Greenbaum CJ, Cowie CC, Skyler JS, and the DPT-1 Study Group. Incident Dysglycemia and the Progression to Type 1 Diabetes among Participants in the Diabetes Prevention Trial-Type 1. Diabetes Care 2009; 32: PMID , PMCID PMC ) Herold KC, Brooks-Worrell B, Palmer JP, Dosch HM, Peakman M, Gottlieb P, Reijonen H, Arif S, Spain LM, Thompson C, Lachin JM, and The Type 1 Diabetes TrialNet Research Group. Validity and Reproducibility of Measurement of Islet Autoreactivity by T-cell Assays in Subjects with Early Type 1 Diabetes. Diabetes 2009; 58: PMID , PMCID PMC ) * Orban T, Sosenko JM, Cuthbertson D, Krischer JP, Skyler JS, Jackson R, Yu L, Palmer JP, Schatz D, Eisenbarth G, and the DPT-1 Study Group. Pancreatic Islet Cell Autoantibodies as Predictors of Type 1 Diabetes in the Diabetes Prevention Trial-Type 1 (DPT-1). Diabetes Care 2009; 32: PMID , PMCID PMC ) 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 D, Wherrett D, Wilson DM, Lachin JM, Skyler JS, and The Type 1 Diabetes TrialNet Anti-CD20 Study Group. Rituximab, B-lymphocyte Depletion and Preservation of Beta-cell Function. N Engl J Med 2009; 361: PMID ) Chase HP, Leschek E, Rafkin-Mervis L, Krause-Steinrauf H, Chritton S, Asare SM, Adams S, Skyler JS, Clare-Salzler M, and the Type 1 Diabetes TrialNet NIP Study Group. Nutritional Intervention to Prevent (NIP) Type 1 Diabetes; A Pilot Trial. ICAN: Infant, Child, & Adolescent Nutrition 2009; 1: ) Bingley PJ, Matthews CL. Type 1 Diabetes TrialNet: Working Together to Prevent, Delay or Slow the Progression of Type 1 Diabetes. Pract Diab Int 2010; 27: ) * Ferrannini E, Mari A, Nofrate V, Sosenko JM, Skyler JS, for the DPT-1 Study Group. Progression to Diabetes in Relatives of Patients with Type 1 Diabetes: Mechanisms and Mode of Onset. Diabetes 2010; 59(3): PMID , PMCID PMC ) * Sosenko JM, Palmer JP, Rafkin LE, Krischer JP, Cuthbertson D, Greenbaum CJ, Eisenbarth GS, Skyler JS, and the DPT-1 Study Group. Trends of Earlier and Later Responses of C-Peptide to Oral Glucose Challenges with Progression to Type 1 Diabetes in Diabetes Prevention Trial-Type 1 Participants. Diabetes Care 2010; 33(3): PMID , PMCID PMC ) Gottlieb PA, Quinlan S, Krause-Steinrauf H, Greenbaum CJ, Wilson DM, Rodriguez H, Schatz DA, Moran AM, Lachin JM, Skyler JS, and the TrialNet MMF/DZB Study Group. Failure to Preserve Beta-Cell Function with Mycophenolate Mofetil and Daclizumab Page 4 of 15

5 Combined Therapy in Patients with New Onset Type 1 Diabetes. Diabetes Care 2010; 33(4): PMID , PMCID PMC ) Petrich de Marquesini LG, Fu J, Connor KJ, Bishop AJ, McLintock NE, Pope C, Wong FS, Dayan CM. IFN-gamma and IL-10 Islet-Antigen-Specific T Cell Responses in Autoantibody-Negative First-Degree Relatives of Patients with Type 1 Diabetes. Diabetologia 2010; 53(7): PMID ) * Sosenko JM, Skyler JS, Krischer JP, Greenbaum CJ, Mahon J, Rafkin-Mervis LE, Cuthbertson D, Cowie C, Herold K, Eisenbarth G, Palmer JP, the Diabetes Prevention Trial-1 Study Group. Glucose Excursions between States of Glycemia with Progression to Type 1 Diabetes in the Diabetes Prevention Trial Type 1 (DPT-1). Diabetes 2010; 59(10): PMID , PMCID PMC ) Grayson BL, Smith ME, Thomas JW, Wang L, Dexheimer P, Jeffrey J, Fain PR, Nanduri P, Eisenbarth GS, Aune TM, Sosenko JM. Genome-Wide Analysis of Copy Number Variation in Type 1 Diabetes. Plos One 2010; 5(11):e TrialNet Ancillary Study PMID , PMCID PMC ) * Xu P, Wu Y, Zhu Y, Dagne G, Johnson G, Cuthbertson D, Krischer J, Skyler J, Sosenko J, and the Diabetes Prevention Trial-1 Study Group. Prognostic Performance of Metabolic Indexes in Predicting Onset of Type 1 Diabetes. Diabetes Care 2010; 33(12): PMID , PMCID PMC ) Lachin J, Friedenberg-McGee P, Greenbaum CJ, Spain L, Palmer J, Pescovitz MD, Gottlieb P, Skyler J, for the Type 1 Diabetes TrialNet Study Group. Sample Size Requirements for Studies of Treatment Effects on Beta-Cell Function in Newly Diagnosed Diabetes. Plos One 2011; 6(11):e PMID , PMCID PMC ) Skyler J, Ricordi C. Perspectives in Diabetes: Stopping Type 1 Diabetes: Attempts to Prevent or Cure Type 1 Diabetes in Man. Diabetes 2011; 60(1):1-8. Published TrialNet and DPT-1 Related Manuscript PMID , PMCID PMC ) * Vehik K, Haller MJ, Beam CA, Schatz DA, Wherrett DK, Sosenko JM, Krischer J, the DPT- 1 Study Group. Islet Autoantibody Seroconversion in the DPT-1 Study: Justification for Repeat Screening Throughout Childhood. Diabetes Care 2011; 34(2): PMID , PMCID PMC ) * Sosenko JM, Mahon J, Rafkin-Mervis L, Lachin JM, Krause-Steinrauf H, Krischer JP, Cuthbertson D, Palmer JP, Thompson C, Greenbaum CJ, Skyler JS, Diabetes Prevention Trial-Type 1 Diabetes (DPT-1) Study Group, Type 1 Diabetes TrialNet Study Group. A Comparison of the Baseline Metabolic Profiles Between Diabetes Prevention Trial-Type 1 and TrialNet Natural History Study Participants. Pediatric Diabetes 2011; 12(2): PMID , PMCID PMC , NIHMS NIHMS ) * Greenbaum CJ, McCulloch-Olson M, Chiu HK, Palmer JP, Brooks-Worrell B. Parenteral Insulin Suppresses T Cell Proliferation to Islet Antigens. Pediatric Diabetes 2011; 12(3 Pt 1): PMID , PMCID PMC , NIHMS NIHMS ) * Vehik K, Cuthbertson D, Ruhling H, Schatz DA, Peakman M, Krischer JP, on behalf of the DPT-1 and TrialNet Study Groups. Long Term Outcome of Individuals Treated with Oral Insulin: Diabetes Prevention Trial-Type 1 (DPT-1) Oral Insulin Trial. Diabetes Care 2011; 34(7): PMID , PMCID PMC ) Wherrett D, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Herold KC, Marks JB, Monzavi R, Moran A, Orban T, Raskin P, Rodrigues H, Schatz D, Wilson DM, Krischer JP, Skyler JS, the TrialNet GAD Study Group. Antigen- Based Therapy with Glutamic Acid Decarboxylase (GAD) Vaccine in Patients with Recent- Page 5 of 15

6 Onset Type 1 Diabetes: A Randomised Double-Masked Controlled Trial. Lancet 2011; 378(9788): PMID , PMCID PMC ) Orban T, Bundy B, Becker DJ, DiMeglio L, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Marks JB, Monzavi R, Moran AM, Raskin P, Rodriguez H, Russell WE, Schatz D, Wherrett D, Wilson DM, Krischer JP, Skyler JS, and the Type 1 Diabetes TrialNet Abatacept Study Group. Co-Stimulation Modulation with Abatacept in Patients with Recent-Onset Type 1 Diabetes: A Randomized Double-Blind, Placebo-Controlled Trial. Lancet 2011; 378(9789): PMID , PMCID PMC , NIHMS NIHMS ) Herold K, Pescovitz M, McGee P, Krause-Steinrauf H, Spain L, Bourcier K, Asare A, Liu Z, Lachin J, Dosch HM, for the Type 1 Diabetes TrialNet Study Group. Increased T Cellular Proliferative Responses to Islet Antigens Identify Clinical Responders to Anti-CD20 Monoclonal Antibody (Rituximab) Therapy in Type 1 Diabetes. J Immunology 2011; 187(4): PMID , PMCID PMC , NIHMS NIHMS ) * Sosenko JM, Skyler JS, Mahon J, Krischer JP, Beam CA, Boulware DC, Greenbaum CJ, Rafkin LE, Cowie C, Cuthbertson D, Palmer JP, the TrialNet and Diabetes Prevention Trial Type 1 Study Groups. The Validation of the Diabetes Prevention Trial-Type 1 Risk Score and the Detection of Pre-Diabetes in the TrialNet Natural History Study. Diabetes Care 2011; 34(8): PMID , PMCID PMC ) * Greenbaum CJ, Buckingham B, Chase HP, Krischer J. Metabolic Tests to Determine Risk for Type 1 Diabetes in Clinical Trials. Diabetes Metab Res Rev 2011; 27(6): PMID , PMCID PMC , NIHMS NIHMS ) Vehik K, Beam CA, Mahon JL, Schatz DA, Haller MJ, Sosenko JM, Skyler JS, Krischer JP, for the TrialNet Natural History Study Group. Development of Autoantibodies in the TrialNet Natural History Study (NHS). Diabetes Care 2011; 34(9): PMID , PMCID PMC ) Yu L, Herold K, Lachin J, Bundy B, Pugliese A, Krischer J, Eisenbarth G, Pescovitz M, Type 1 Diabetes TrialNet Anti-CD20 Study Group. Rituximab Selectively Suppresses Specific Islet Antibodies. Diabetes 2011; 60(10): PMID , PMCID PMC ) Mahon JL, Beam CA, Marcovina SM, Boulware DC, Palmer JP, Winter WE, Skyler JS, Krischer JP, and the Type 1 Diabetes TrialNet Study Group. Comparison of Two Insulin Assays for First-Phase Insulin Release in Type 1 Diabetes Prediction and Prevention Studies. Clin Chim Acta 2011; 412(23-24): PMID , PMCID PMC , NIHMS NIHMS ) * Sosenko JM, Skyler JS, Palmer JP, Krischer JP, Cuthbertson D, Yu L, Schatz DA, Orban T, Eisenbarth G, Diabetes Prevention Trial-Type 1, and Type 1 Diabetes TrialNet Study Groups. A Longitudinal Study of GAD65 and ICA512 Autoantibodies during the Progression to Type 1 Diabetes in Diabetes Prevention Trial-Type 1 (DPT-1) Participants. (Brief Report) Diabetes Care 2011; 34(11): PMID , PMCID PMC ) Pescovitz M, Torgerson TR, Ochs HD, Ocheltree E, McGee P, Krause-Steinrauf H, Lachin JM, Canniff J, Greenbaum C, Herold KC, Skyler JS, Weinberg A, the Type 1 Diabetes TrialNet Study Group. Effect of Rituximab on Human In Vivo Antibody Immune Responses. J Allergy Clin Immunol 2011; 128(6): e5. PMID , PMCID PMC ) Yu L, Boulware DC, Beam CA, John CHutton JC, Wenzlau JM, Greenbaum CJ, Bingley PJ, Krischer JP, Sosenko JM, Skyler JS, Eisenbarth GS, Mahon JL, for the Type 1 Page 6 of 15

7 Diabetes TrialNet Study Group. Zinc Transporter-8 Autoantibodies Improve Prediction of Type 1 Diabetes in Relatives Positive for the Standard Biochemical Autoantibodies. Diabetes Care 2012; 35(6): PMID , PMCID PMC ) * Sosenko JM, Skyler JS, Herold KC, Palmer JP. The Metabolic Progression to Type 1 Diabetes as Indicated by Serial Oral Glucose Tolerance Testing in the Diabetes Prevention Trial-Type 1. Diabetes 2012; 61(6): PMID , PMCID PMC ) * Sosenko JM, Skyler JS, Mahon J, Krischer JP, Beam CA, Boulware DC, Greenbaum CJ, Rafkin LE, Cowie C, Cuthbertson D, Palmer JP, The TrialNet and Diabetes Prevention Trial-Type 1 Study Groups. The Application of the Diabetes Prevention Trial Risk Score (DPTRS) for Identifying a Pre-Clinical State of Type 1 Diabetes. Diabetes Care 2012; 35(7): PMID , PMCID PMC ) 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, Sosenko JM, Type 1 Diabetes TrialNet Study Group. Fall in C-peptide Over First Two Years from Diagnosis: Evidence of At Least Two Distinct Phases from Composite TrialNet Data. Diabetes 2012; 61(8): PMID , PMCID PMC ) Vehik K, Cuthbertson D, Boulware D, Beam CA, Rodriguez H, Legault L, Hyytinen M, Rewers M, Schatz DA, Krischer JP, and the TEDDY, TRIGR, Diabetes Prevention Trial- Type 1, and Type 1 Diabetes TrialNet Natural History Study Groups. Performance of HbA1c as an Early Diagnostic Indicator of Type 1 Diabetes in Children and Youth. Diabetes Care 2012; 35(9): PMID , PMCID PMC ) Long SA, Rieck M, Sanda S, Bollyky JB, Samuels PL, Goland R, Ahmann A, Rabinovitch A, Aggarwal S, Phippard D, Turka LA, Ehlers MR, Bianchine PJ, Boyle KD, Adah SA, Bluestone JA, Buckner JH, Greenbaum CJ, for the Diabetes TrialNet, and the Immune Tolerance Network. Rapamycin/IL-2 Combination Therapy in Patients with Type 1 Diabetes Augments Tregs yet Transiently Impairs B-Cell Function. Diabetes 2012; 61(9): PMID , PMCID PMC ) * Xu P, Beam CA, Cuthbertson D, Sosenko JM, Skyler JS, Krischer JP, and the DPT-1 Study Group.. Prognostic Accuracy of Immunologic and Metabolic Markers for Type 1 Diabetes in a High Risk Population - Receiver Operating Characteristic Analysis. Diabetes Care 2012; 35(10): PMID , PMCID PMC ) * Han DM, Cai X, Wen J, Matheson D, Skyler JS, Kenyon NS, Chen Z: Innate and Adaptive Immune Gene Expression Profiles as Biomarkers in Human Type 1 Diabetes. Clin Exp Immunol ; (TrialNet Ancillary Study PMID , PMCID PMC ) Alkanani AK, Rewers M, Waugh K, Barriga K, Gottlieb PA, Zipris D. Dysregulated Toll-like Receptor-induced Interleukin-1B and Interleukin-6 Responses in Subjects at Risk for the Development of Type 1 Diabetes. Diabetes 2012; 61(10): PMID , PMCID PMC ) Han DM, Cai X, Wen J, Matheson D, Skyler JS, Kenyon NS, Chen Z. Innate and Adaptive Immune Gene Expression Profiles as Biomarkers in Human Type 1 Diabetes. Clin Exp Immunol 2012; 170(2): PMID , PMCID PMC ) Loechelt BJ, Boulware D, Green M, Baden LR, Gottlieb P, Krause-Steinrauf H, Weinberg A, for the Type 1 Diabetes TrialNet Daclizumab/Mycophenolic Acid Study Group. Epstein Barr & Other Herpesvirus Infections in Patients with Early Onset Type 1 Diabetics Treated with Daclizumab & Mycophenolic Mofetil. Clinical Infectious Diseases 2013; 56(2): PMID , PMCID PMC Page 7 of 15

8 78) Larsson HE, Jonsson I, Lernmark A, Ivarsson S, Radtke JR, Hampe CS, and the Diabetes Prediction in Skane (DiPiS), and Type 1 Diabetes TrialNet studies. Decline in Titers of Anti- Idiotypic Antibodies Specific to Autoantibodies to GAD65 (GAD65Ab) Precedes Development of GAD65Ab and Type 1 Diabetes. Plos One 2013; 8(6):e PMID , PMCID PMC ) Diabetes Research in Children Network (DirecNet); Type 1 Diabetes TrialNet Study Groups, Buckingham BA, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Cantwell M. The Effects of Inpatient Hybrid Closed- Loop Therapy Initiated within 1 Week of Type 1 Diabetes Diagnosis. Diabetes Technol Ther 2013; 15(5): PMID , PMCID PMC ) Valle A, Giamporcaro GM, Scavini1 M, Stabilini A, Grogan P, Bianconi E, Sebastiani G, Masini M, Maugeri N, Porretti L, Bonfanti R, Meschi F, De Pellegrin M, Lesma A, Rossini S, Piemonti L, Marchetti P, Dotta F, Bosi E, Battaglia M. Reduced Circulating Neutrophils Precedes and Accompanies Type 1 Diabetes. Diabetes 2013; 62(6): (TrialNet Ancillary Study) PMID , PMCID PMC ) Kroll JL, Beam C, Li S, Viscidi R, Pescovitz M, Weinberg A, the Type 1 Diabetes TrialNet Anti CD-20 Study Group. Reactivation of Latent Viruses in Individuals Receiving Rituximab for New Onset Type 1 Diabetes. J Clin Virol 2013; 57(2): (TrialNet Ancillary Study PMID , PMCID PMC ) Moran A, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Greenbaum CJ, Herold KC, Marks JB, Sanda S, Raskin P, Schatz D, Wherrett DK, Wilson DM, Krischer JP, Skyler JS, Pickersgill L, de Koning E, Ziegler A-G, Boehm B, Badenhoop K, Schloot N, Bak JF, Pozzilli P, Mauricio D, Donath MY, Castano L, Wagner A, Lervang HH, Perrild H, Mandrup-Poulsen T. Interleukin-1 Antagonism in Type 1 Diabetes of Recent Onset: Two Multicenter, Randomized Double-Masked, Placebo-Controlled Trials. Lancet 2013; 381(9881): PMID , PMCID PMC ) Krischer JP, the Type 1 Diabetes TrialNet Study Group. The Use of Intermediate Endpoints in the Design of Type 1 Diabetes Prevention Trials. Diabetologia 2013; 56(9): PMID , PMCID PMC ) * Sosenko JM, Skyler JS, Palmer JP, Krischer JP, Yu L, Mahon J, Beam CA, Boulware DC, Rafkin L, Schatz D, Eisenbarth G, the Type 1 Diabetes TrialNet, and the Diabetes Prevention Trial-Type 1 Study Groups. The Prediction of Type 1 Diabetes by Multiple Autoantibody Levels and Their Incorporation into an Autoantibody Risk Score in Relatives of Type 1 Diabetes Patients. Diabetes Care 2013; 36(9): PMID , PMCID PMC ) * Adl AA, Qian X, Xu P, Vehik K, Krischer JP. Feature Ranking Based on Synergy Networks to Identify Prognostic Markers in DPT-1. EURASIP J Bioinform Syst Biol 2013; 2013(1):12. PMID , PMCID PMC ) McCarlie VW, Hartsfield Jr JK, Blum JS, Gonzalez-Cabezar C, Chin JR, Eckert GJ, Morford L, Pescovitz M, Rodriguez H, Fontaina M, Gregory RL. Total IgA and IgA Reactivity to Antigen I/II Epitopes in HLA-DRB1*04 Positive Subjects. Open J Immuol 2013; 3(3): (TrialNet Ancillary Study PMID , PMCID PMC ) * Adl AA, Qian X, Xu P, Vehik K, Krischer JP. Feature Ranking Based on Synergy Networks to Identify Prognostic Markers in DPT-1. IEEE Xplore 2013; 2013(1): IEEE International Workshop on Genomic Signal Processing and Statistics (GENSIPS), Data Mining and Modeling Methods in Next-Generation Sequencing and Cancer Systems Biology. Washington DC, December 2-4, 2012, IEEE Xplore, p PMID , PMCID PMC Page 8 of 15

9 88) Weinberg A, Boulware D, Dighero B, Orban T, for the Type 1 Diabetes Abatacept Study Team. Effect of Abatacept on Immunogenicity of Vaccines in Individuals with Type 1 Diabetes. Vaccine 2013; 31(42): PMID , PMCID PMC ) * Sosenko JM, Skyler JS, Beam CA, Krischer JP, Greenbaum CJ, Mahon J, Rafkin LE, Matheson D, Herold KC, Palmer JP, and the Type 1 Diabetes TrialNet and the Diabetes Prevention Trial-Type 1 Study Groups. Acceleration of the Loss of the First-Phase Insulin Response during the Progression to Type 1 Diabetes in Diabetes Prevention Trial-Type 1 Participants. Diabetes 2013; 62(12): PMID , PMCID PMC ) Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV, Diabetes Research in Children Network (DirecNet), Type 1 Diabetes TrialNet Study Groups. Effectiveness of Early Intensive Therapy on Beta- Cell Preservation in Type 1 Diabetes. Diabetes Care 2013; 36(12): PMID , PMCID PMC ) Creusot RJ, Trucco M, Clare-Salzler MJ, Fathman CG. It's Time to Bring Dendritic Cell Therapy to Type 1 Diabetes. Diabetes 2014; 63(1): Published TrialNet and DPT-1 Related Manuscript PMID , PMCID PMC ) Pescovitz M, Greenbaum CJ, Bundy B, Becker DJ, Gitelman SE, Goland R, Gottieb PA, Marks JP, Moran AM, Raskin P, Rodriguez H, Schatz DA, Wherrett D, Wilson DM, Krischer JP, Skyler JS and the Type 1 Diabetes TrialNet Anti-CD20 Study Group. B-lymphocyte Depletion with Rituximab and Beta-Cell Function: Two-Year Results. Diabetes Care 2014; 37(2): PMID , PMCID PMC ) Orban T, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Marks JB, Monzavi R, Moran A, Raskin P, Russell WE, Schatz D, Wherrett D, Wilson DM, Krischer JP, Skyler JS, the Type 1 Diabetes TrialNet Abatacept Study Group. Costimulation Modulation with Abatacept in Patients with Recent-Onset Type 1 Diabetes: Follow-up One Year After Cessation of Treatment. Diabetes Care 2014; 37(4): PMID , PMCID PMC ) Sosenko JM, Skyler JS, Mahon J, Krischer JP, Greenbaum CJ, Rafkin LE, Beam CA, Boulware DC, Matheson D, Cuthbertson D, Herold KC, Eisenbarth G, Palmer JP; the Diabetes Type 1 TrialNet, and Diabetes Prevention Trial-Type 1 Study Groups. Use of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS) for Improving the Accuracy of the Risk Classification of Type 1 Diabetes. Diabetes Care 2014; 37(4): PMID , PMCID PMC ) Lin Y, Qian X, Krischer J, Vehik K, Lee H-S, Huang S. A Rule-Based Prognostic Model for Type 1 Diabetes by Identifying and Synthesizing Baseline Profile Patterns. Plos One 2014; 9(6):e PMID , PMCID PMC ) * Xu P, Qian X, Schatz DA, Cuthbertson D, Krischer JP, and the DPT-1 Study Group. Distribution of C-Peptide and its Determinants in North American Children at Risk for Type 1 Diabetes. Diabetes Care 2014; 37(7): PMID , PMCID PMC ) Max Andersen ML, Nielsen LB, Svensson J, Porksen S, Hougaard P, Beam C, Greenbaum C, Becker D, Petersen JS, Hansen L, Mortensen HB. Disease Progression Among 446 Children with Newly Diagnosed Type 1 Diabetes Located in Scandinavia, Europe and North America during the Last 27 Years. Pediatric Diabetes 2014; 15(5): PMID ) Beam CA, Gitelman SE, Palmer J, and the Type 1 Diabetes TrialNet Study Group. Recommendations for the Definition of Clinical Responder in Insulin Preservation Studies. Diabetes 2014; 63(9): PMID , PMCID PMC Page 9 of 15

10 99) Usmani-Brown S, Lebastchi J, Steck AK, Beam C, Herold KC, Ledizet M. Analysis of Beta Cell Death in Type 1 Diabetes by Digital Droplet PCR. Endocrinology 2014; 155(9): TrialNet Ancillary Study PMID , PMCID PMC ) Orban T, Beam CA, Xu P, Moore K, Jiang Q, Deng J, Muller S, Gottlieb P, Spain L, Peakman M, and the Type 1 Diabetes TrialNet Abatacept Study Group. Reduction in CD4 Central Memory T-cell subset in Co-Stimulation Modulator Abatacept-Treated Patients with Recent-Onset Type 1 Diabetes is Associated with Slower C-Peptide Decline. Diabetes 2014; 63(10): PMID , PMCID PMC ) * Arif S, Leete P, Nguyen V, Marks K, Nor NM, Estominho M, Kronenberg-Versteeg D, Bingley PJ, Todd JA, Guy C, Dunger DB, Powrie J, Willlcox A, Foulis AK, Richardson SJ, de Rinaldis E, Morgan NG, Lorenc A, Peakman M. Blood and Islet Phenotypes Indicate Immunological Heterogeneity in Type 1 Diabetes. Diabetes 2014; 63(11): (TrialNet Ancillary Study) PMID , PMCID PMC ) * Sajjadi SJ, Qian X, Zeng B, Adl AA. Network-Based Methods to Identify Highly Discriminating Subsets of Biomarkers. IEEE Xplore 2014; 11(6): IEEE International Workshop on Genomic Signal Processing and Statistics (GENSIPS), Data Mining and Modeling Methods in Next-Generation Sequencing and Cancer Systems Biology. Washington DC, December 2-4, 2012, IEEE Xplore, p PMID , PMCID PNC Journal - In Process ) Sosenko JM, Skyler JS, DiMeglio LA, Beam CA, Krischer JP, Greenbaum CJ, Boulware D, Rafkin LE, Matheson D, Herold KC, Mahon J, Palmer JP, Type 1 Diabetes TrialNet Study Group, Diabetes Prevention Trial-Type 1 Study Group. A New Approach for Diagnosing Type 1 Diabetes in Autoantibody-Positive Individuals Based on Prediction and Natural History. Diabetes Care 2015; 38(2): PMID , PMCID PMC ) Miao D, Steck AK, Zhang L, Guyer KM, Jiang L, Armstrong T, Muller SM, Krischer J, Rewers M, Yu L, Type 1 Diabetes TrialNet Study Group. Electrochemiluminescence Assays for Insulin and Glutamic Acid Decarboxylase Autoantibodies Improve Prediction of Type 1 Diabetes Risk. Diabetes Technol Ther 2015; 17(2): (TrialNet Ancillary Study PMID , PMCID PMC ) * Ismail H, Krischer J, Chase HP, Cuthbertson D, Palmer J. First Test Effect in Intravenous Glucose Tolerance Testing. Pediatric Diabetes 2015; 16(2): Aug 15 Epub ahead of print. PMID , PMCID PMC ) Herold KC, Usmani-Brown S, Ghazi T, Lebastchi J, Beam CA, Bellin MD, Ledizet M, Sosenko JM, Krischer JP, Palmer JP, and the Type 1 Diabetes TrialNet Study Group. Beta Cell Death and Dysfunction during Type 1 Diabetes Development in At-risk Individuals. J Clin Invest 2015; 125(3): (TrialNet Ancillary Study) PMID , PMCID PMC ) Valle A, Barbagiovanni G, Jofra T, Stabilini A, Perol L, Baeyens A, Anand Santosh, Cagnard N, Nicola G, Piaggio E, Battaglia M. Heterogeneous CD3 Expression Levels in Differing T-cell Subsets Correlate with the In Vivo Anti-CD3?mediated T-cell Modulation. J Immunol 2015; 194(3): (TrialNet Ancillary Study) PMID ) Hao W, Greenbaum CJ, Krischer JP, Cuthbertson D, Marks JB, Palmer JP. The Effect of the DPT-1 Intravenous Insulin Infusion & Daily Subcutaneous Insulin on Endogenous Insulin Secretion & Post-Prandial Glucose Tolerance. Diabetes Care 2015; 38(5): PMID , PMCID PMC ) Sosenko JM, Skyler JS, Beam CA, Boulware D, Mahon JL, Krischer JP, Greenbaum CJ, Rafkin LE, Matheson D, Herold KC, Palmer JP, The Diabetes Type 1 TrialNet, and Page 10 of 15

11 Diabetes Prevention Trial-Type 1 Study Groups. The Development and Utility of a Novel Scale that Quantifies the Glycemic Progression toward Type 1 Diabetes over Six Months. Diabetes Care 2015; 38(5): PMID , PMCID PMC ) Smith MJ, Packard TA, O Neill SK, Henry Dunand CJ, Huang M, Fitzgerald-Miller L, Stowell D, Hinman RM, Wilson PC, Gottlieb PA, Cambier JC. Loss of Anergic B Cells in Pre-diabetic and New Onset T1D Patients. Diabetes 2015; 64(5): PMID , PMCID PMC ) Buckingham B, Cheng P, Beck RW, Kollman C, Ruedy KJ, Weinzimer SA, Slover R, Bremer AA, Fuqua J, Tamborlane W, Diabetes Research in Children Network (DirecNet), and Type 1 Diabetes TrialNet Study Groups. CGM Measured Glucose Values Have a Strong Correlation with C-peptide, A1c, and IDAAC, But Do Poorly in Predicting C-peptide Levels in the Two Years Following Onset of Diabetes. Diabetologia 2015; 58(6): PMID , PMCID PMC ) Chase HP, Boulware D, Rodriguez H, Donaldson D, Chritton S, Rafkin-Mervis L, Krischer J, Skyler JS, Clare-Salzler M, Type 1 Diabetes TrialNet Nutritional Intervention to Prevent (NIP) Type 1 Diabetes Study Group. Effect of Docosahexaenoic Acid (DHA) Supplementation on Inflammatory Cytokine Levels in Infants at High Genetic Risk of Type 1 Diabetes. Pediatric Diabetes 2015; 16(4): /12/14 Epub ahead of print. PMID , PMCID PMC ) * Sosenko JM, Skyler JS, Palmer JP, The Diabetes Type 1 TrialNet, and Diabetes Prevention Trial-Type 1 Study Groups. The Development, Validation, and Utility of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS). Curr Diab Rep 2015; 15(8):626. PMID , PMCID PMC ) Loechelt BJ, Green M, Gottlieb PA, Blumberg E, Weinberg A, Quinlan S, Baden LR, Marks J, Type 1 Diabetes TrialNet. Screening and Monitoring of Infectious Complications when Immunosuppression Agents are Studied in the Treatment of Autoimmune Disorders. J Pediatric Infect Dis Soc 2015; 4(3): (2014; June 26 Epub ahead of print). PMID , PMCID PMC ) Bollyky JB, Xu P, Butte AJ, Wilson DM, Beam CA, Greenbaum CJ, Type 1 Diabetes TrialNet Study Group. Heterogeneity in Recent Onset Type 1 Diabetes a Clinical Trial Perspective. Diabetes Metab Res Rev 2015; 31(6): ;Apr 23 Epub ahead of print PMID , PMCID PMC ) Alkanani AK, Hara N, Gottlieb PA, Ir D, Robertson CE, Wagner BD, Frank DN, Zipris D. Alterations in Intestinal Microbiota Correlate with Susceptibility to Type 1 Diabetes. Diabetes 2015; 64(10): June 11 Epub ahead of print. PMID , PMCID PMC ) Wherrett DK, Chiang JL, Delamater AM, DiMeglio LA, Gitelman SE, Gottlieb PA, Herold KC, Lovell DJ, Orchard TJ, Ryan CM, Schatz DA, Wendler DS, Greenbaum CJ, Type 1 Diabetes TrialNet Study Group. Defining Pathways for Development of Disease-Modifying Therapies in Children With Type 1 Diabetes: A Consensus Report. Diabetes Care 2015; 38(10): PMID , PMCID PMC ) Bingley PJ, Rafkin L, Matheson D, Steck A Yu L, Henderson C, Beam C, Boulware D, and the Type 1 Diabetes TrialNet Study Group. Use of Dried Capillary Blood Sampling for Islet Autoantibody Screening in Relatives: a Feasibility Study. Diabetes Technol Ther 2015; 17(12): (PMC available 12/1/16), 2015 Sep 16 Epub ahead of print PMID , PMCID PMC Page 11 of 15

12 119) Chamberlain N, Massad C Oe T, Cantaert T, Herold KC, Meffre E, and the Type 1 Diabetes TrialNet Study Group. Rituximab Does Not Reset Defective Early B-Cell Tolerance Checkpoints. J Clin Invest 2016; 126(1): Dec 7 Epub ahead of print, Accepted November 2015 Old Title: Rituximab Mediated B-Cell Depletion Does Not Reset Early B-Cell Tolerance Checkpoints Defective in Type 1 Diabetes Mellitus Patients PMID , PMCID PMC ) Kryvalap Y, Lo C-W, Manuylova E, Baldzizhar R, Jospe N, Czyzyk J. Antibody Response to Serpin B13 Induces Adaptive Changes in Mouse Pancreatic Islets and Slows Down the Decline in the Residual Beta Cell Function in Children with Recent Onset in Type 1 Diabetes Mellitus. J Biol Chem 2016; 291(1): (PMC available 1/1/17), (TrialNet Biosample Repository), 2015; Nov 17 Epub ahead of print. PMID , PMCID PMC ) Bingley P, Boulware D, Krischer JP, for the Type 1 Diabetes TrialNet Study Group. The Implications of Autoantibodies to a Single Islet Antigen in Relatives with Normal Glucose Tolerance: Development of Other autoantibodies and Progression to Diabetes.. Diabetologia 2016; 59(3): Dec 16 Epub ahead of print, Accepted November 3, 2015 PMID , PMCID PMC ) Pugliese A, Boulware D, Yu L, Babu S, Steck AK, Becker D, Rodriguez H, DiMeglio L, Evans-Molina C, Harrison LC, Schatz D, Palmer JP, Greenbaum C, Eisenbarth GS, Sosenko JM, the Type 1 Diabetes TrialNet Study Group. The HLA-DRB1*15:01- DQA1*01:02-DQB1*06:02 Haplotype Protects Autoantibody-Positive Relatives from Type 1 Diabetes Throughout the Stages of Disease Progression. Diabetes 2016; 65(4): (PMC available 4/1/17), Jan 28 Epub ahead of print Accepted January 25, PMID , PMCID PMC ) Cabrera SM, Wang X, Chen YG, Jia S, Kaldunski ML, Greenbaum CJ, Type 1 Diabetes TrialNet Canakinumab Study Group, Mandrup-Poulsen T, AIDA Study Group, Hessner MJ.. Interleukin-1 Antagonism Moderates the Inflammatory State Associated with Type 1 Diabetes during Clinical Trials Conducted at Disease Onset. Eur J Immunol 2016; 46(4): (PMC available 4/1/17), 2015 Dec 22 Epub ahead of print PMID , PMCID PMC ) Triolo TM, Maahs DM, Pyle L, Slover R, Buckingham B, Cheng P, DiMeglio L, Bremer A, Weinzimer S, Chase HP, Diabetes Research in Children Network (DirecNet), Type 1 Diabetes TrialNet Study Groups. The Effects of Frequency of Sensor Augmented Pump Use on HbA1c and C-Peptide Levels in the First Year of Type 1 Diabetes. Diabetes Care 2016; 39(4):e61-e62. (PMC available 4/1/17), Feb 19 Epub ahead of print Accepted 1/14/16 PMID , PMCID PMC ) Moya R, Robertson HK, Payne D, Narsale A, Koziol J., the Type 1 Diabetes TrialNet Study Group, and Davies JD. A Pilot Study Showing Associations Between Frequency of CD4+ Memory Cell Subsets at Diagnosis and Duration of Partial Remission in Type 1 Diabetes. Clinical Immunology 2016; : (PMC available 5/1/17), 2016; April 22 Epub ahead of print Accepted 4/21/16. PMID , PMCID PMC ) DiMeglio LA, Cheng P, Beck RW, Kollman C, Ruedy KJ, Slover R, Aye T, Weinzimer SA, Bremer AA, Buckingham B, for the Diabetes Research in Children Network (DirecNet), and Type 1 Diabetes TrialNet Study Group. Changes in Beta Cell Function during the Proximate Post-Diagnosis Period in Persons with Type 1 Diabetes. Pediatric Diabetes 2016; 17(4): (PMC available 6/1/17), Feb 27 Epub ahead of print, PMID , PMCID PMC ) Meah FA, DiMeglio LA, Greenbaum CJ, Blum JS, Sosenko JM, Pugliese A, Geyer S, Xu P, Evans-Molina C, Type 1 Diabetes TrialNet Study Group. The Relationship Page 12 of 15

13 Between Body Mass Index and Insulin Resistance and Progression from Single to Multiple Autoantibody Positive and Type 1 Diabetes Among TrialNet Pathway to Prevention Participants. Diabetologia 2016; 59(6): (PMC available 6/1/17), 2016 Mar 19 Epub ahead of print, Accepted March 2016 PMID , PMCID PMC ) Xu P, Krischer JP, on behalf of the TrialNet Natural History Study Group. Prognostic Classification Factors Associated with Development of Multiple Autoantibodies, Dysglycemia and Type 1 Diabetes - A Recursive Partitioning Analysis. Diabetes Care 2016; 39(6): (PMC available 6/1/17), Accepted 3/16/16. PMID , PMCID PMC ) Steck AK, Fouts A, Miao D, Zhao Z, Dong F, Sosenko J, Gottlieb P, Rewers MJ, Yu L, TrialNet Study Group. ECL-IAA and ECL-GADA can Identify High Risk Single Autoantibody Positive Relatives in the TrialNet Pathway to Prevention Study. Diabetes Technol Ther 2016; 18(7): (PMC available 7/1/17), 2016 Mar 18 Epub ahead of print, 2/22/16 Accepted. PMID , PMCID PMC ) Narsale A, Moya R, Robertson HK, the Type 1 Diabetes TrialNet Study Group, and Davies JD. Data on Correlations Between T Cell Subset Frequencies and Length of Partial Remission in Type 1 Diabetes. Data in Brief 2016; 8: Accepted as a Data in Brief with the manuscript entitled "A Pilot Study Showing Associations Between Frequency of CD4+ Memory Cell Subsets at Diagnosis and Duration of Partial Remission in Type 1 Diabetes". Old title: Immune Cell Subsets Frequencies in Patients Newly Diagnosed with Type 1 Diabetes. PMID , PMCID PMC ) * Sosenko JM. Staging the Progression to Type 1 Diabetes with Prediagnostic Markers. Curr Opin Endocrinol Diabetes Obes 2016; 23(4): (PMC available 8/1/17). Review Article PMID , PMCID PMC ) Sims EK, Chaudhry Z, Watkins R Syed F, Blum J, Ouyang F, Perkins S, Mirmira R, Sosenko J, DiMeglio LA, Evans-Molina C, and the Type 1 Diabetes Study Group. Elevations in Fasting Serum Proinsulin: C-peptide Ratio Predate Onset of Type 1 Diabetes. Diabetes Care 2016; 39(9): (PMC available 09/01/17), 2016 July 6 Epub ahead of print, Diabetes Care Accepted 6/10/16. PMID , PMCID PMC ) Hao W, Gitelman S, DiMeglio LA, Boulware D, Greenbaum CJ, for the Type 1 Diabetes TrialNet Study Group. Fall in C-Peptide During First 4 Years from Diagnosis of Type 1 Diabetes: Variable Relation to Age, HbA1c and Insulin Dose. Diabetes Care 2016; 39(10): (PMC available 10/1/17) 2016 July 15 Epub ahead of print, Accepted 6/15/16. PMID , PMCID PMC ) Fouts A, Pyle L, Yu L, Miao D, Michels A, Krischer J, Sosenko J, Gottlieb P, Steck AK, Type 1 Diabetes TrialNet Study Group. Do Electrochemiluminescence Assays Improve Prediction of Time to Type 1 Diabetes in Autoantibody-Positive TrialNet Subjects?. Diabetes Care 2016; 39(10): (PMC available 10/1/17) 2016 Jul 25 Epub ahead of print. Diabetes Care accepted 7/11/16. Manuscript original title: Factors Involved In Predicting Time to Type 1 Diabetes in Autoantibody Positive TrialNet Subjects PMID , PMCID PMC ) Durning SP, Preston-Hurlburt P, Clark PR, Xu D, Herold KC, Type 1 Diabetes TrialNet Study Group. The Receptor for Advanced Glycation Endproducts Drives T Cell Survival and Inflammation in Type 1 Diabetes Mellitus. J Immunol 2016; 197(8): , Sept 21 Epub ahead of print. PMID , PMCID PMC ) Bundy B, Krischer JP, Type 1 Diabetes TrialNet Study Group. A Model Based Approach to Sample Size Estimation in Recent Onset Type 1 Diabetes. Diabetes Page 13 of 15

14 Metab Res Rev 2016; 32(8): (PMC available 11/1/17), 2016 Mar 19 Epub ahead of print Accepted March 2016 PMID , PMCID PMC ) Beam CA, MacCallum C, Herold KC, Wherrett DK, Palmer JP, Ludvigsson J, the Type 1 Diabetes TrialNet Study Group. GAD Vaccine Reduces Insulin Loss in Recently- Diagnosed Type 1 Diabetes: Findings from a Bayesian Meta-Analysis. Diabetologia 2017; 60(1): Oct 4 Epub ahead of print. 8/31/16 Accepted by Diabetologia. PMID , PMCID PMC in process 138) Marwaha AK, Panagiotopoulos J, Biggs C, Staiger S, Long A, Cerosaletti K, Del Bell KL, Hirschfeld AF, Priatel J, Buckner J, Turvey SE, Tan R. Pre-diagnostic Genotyping Identifies T1D Subjects with Impaired Treg IL-2 Signaling and an Elevated Proportion of FOXP3+IL-17+ Cells. Genes Immunity 2017; 18(1): Jan 5 Epub ahead of print, 10/24/16 journal accepted manuscript. PMID , PMCID PMC as supplied by publisher 139) Sosenko JM, Yu L, Skyler JS, Krischer JP, Gottlieb PA, Boulware D, Miao D, Palmer JP, Steck AK, the Type 1 Diabetes TrialNet Study Group. The Use of Electrochemiluminescence (ECL) Assays to Predict Autoantibody and Glycemic Progression Toward Type 1 Diabetes in Individuals with Single Autoantibodies. Diabetes Technol Ther 2017; 19(3): (available 3/1/18), 2017 Feb 8 Epub ahead of print, Accepted 1/5/17. PMID , PMCID PMC ) Ferrara CT, Geyer SM, Liu Y-F, Evans-Molina C, Libman IM, Besser R, Becker DJ, Rodriguez H, Moran A, Gitelman SE, Redondo MJ, Type 1 Diaetes TrialNet Study Group. Excess Body Mass Index in Childhood: A Modifiable Risk Factor for Type 1 Diabetes Development?. Diabetes Care 2017; 40(5): (available 5/1/18). Feb 15 Epub ahead of print. 1/30/17 accepted as Noval Communication. PMID , PMCID PMC ) Liu Y-F, Rafkin L, Matheson D, Henderson C, Boulware D, Besser R, Ferrara C, Yu L, Steck AK, Bingley PJ, the Type 1 Diabetes TrialNet Study Group. Use of Self- Collected Capillary Blood Samples for Islet Autoantibody Screening in Relatives: A Feasibility and Acceptability Study. Diabetic Medicine 2017; 34(7): Accepted 2/6/17. PMID , PMCID PMC in process 142) Sanda S, the Type 1 Diabetes TrialNet Study Group. Increasing ICA512 Autoantibody Titers Predict Development of Abnormal Oral Glucose Tolerance Tests. Pediatric Diabetes Jul 14 Epub ahead of print, Accepted 4/25/17. PMID , PMCID PMC in process 143) Snowhite IV, Allende G, Sosenko J, Pastori RL, Messinger Cayetano S, Pugliese A. Association of Serum MicroRNAs with Islet Autoimmunity, Disease Progression and Metabolic Impairment in Relatives At-Risk for Type 1 Diabetes. Diabetologia 2017; 60(8): May 12 Epub ahead of print. Accepted 3/31/17. PMID , PMCID PMC in process 144) Bosi E, Boulware DC, Becker DJ, Buckner JH, Geyer S, Gottlieb PA, Henderson C, Kinderman A, Sosenko JM, Steck AK, Bingley PJ, Type 1 Diabetes TrialNet Study Grou. Impact of Age and Antibody Type on Progression from Single to Multiple Autoantibodies in Type 1 Diabetes Relatives. J Clin Endocrinol Metab 2017; 102(8): May 22 Epub ahead of print, Accepted 5/17/17. PMID , PMCID PMC ) Battaglia M, Anderson MS, Buckner JH, Geyer SM, Gottlieb PA, Kay TWH, Lernmark A, Muller S, Pugliese A, Roep BO, Greenbaum CJ, Peakman M. Understanding and Preventing Type 1 Diabetes through the Unique Working Model of TrialNet. Page 14 of 15

15 Diabetologia Aug 2 Epub ahead of print. Accepted June 9, Review article that emphasizes the Biorepository and the Mechanistic Studies of TrialNet. PMID , PMCID PMC in process 146) Steck AK, Xu P, Geyer S, Redondo MJ, Antinozzi P, Wentworth JM, Sosenko J, Onengut-Gumuscu S, Chen WM, Rich SS, Pugliese A7; Type 1 Diabetes TrialNet Study Group.. Can non-hla Single Nucleotide Polymorphisms Help Stratify Risk in TrialNet Relatives at Risk for Type 1 Diabetes?. J Clin Endoclin Metab 2017; 102(8): May 17 Epub ahead of print. PMID , PMCID PMC ) * Nathan BM, Boulware D, Geyer S, Atkinson MA, Colman P, Goland R, Russell W, Wentworth J, Wilson DM, Evans-Molina C, Wherrett D, Skyler JS, Moran A, Sosenko JM, Type 1 Diabetes TrialNet and Diabetes Prevention Trial Type 1 Study Groups. Dysglycemia and Index60 as Pre-diagnostic Endpoints for Type 1 Diabetes Prevention Trials. Diabetes Care Accepted for publication 8/8/ ) Ismail HM, Xu P, Libman IM, Becker DJ, Marks JB, Skyler JS, Palmer JP, Sosenko JM, Type 1 Diabetes TrialNet Study Group. The Shape of the Glucose Concentration Curve during an Oral Glucose Tolerance Test Predicts Risk for Type 1 Diabetes. Diabetologia Accepted August 15, ) Redondo MJ, Geyer S, Steck AK, Sosenko J, Anderson M, Antinozzi P, Michels A, Wentworth J, Xu P, Pugliese A, Type 1 Diabetes TrialNet Study Group. TCF7L2 Genetic Variants Contribute to Phenotypic Heterogeneity of Type 1 Diabetes. Diabetes Care Accepted August 17, ) Yip L, Fuhlbrigge R, Atkinson MA, Fathman CG. Impact of Blood Collection and Processing on Peripheral Blood Gene Expression Profiling for Type 1 Diabetes. BMC Genomics 2017; 18(1):636. Accepted 8/18/17 PMID , PMCID PMC Page 15 of 15