Diabetes Mellitus, Insulin-Dependent
Item
1. participants who meet the american diabetes association type 1 diabetes mellitus (t1dm) criteria
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Enrollment
Item
2. diagnosis of t1dm within 100 days of enrollment
boolean
C0011854 (UMLS CUI [1])
C1516879 (UMLS CUI [2])
Diabetes Related Autoantibody positive
Item
3. positive for at least one diabetes-related autoantibody, including but not limited to:
boolean
C0011847 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0853878 (UMLS CUI [1,3])
Glutamate Decarboxylase
Item
1. glutamate decarboxylase (gad-65)
boolean
C0017785 (UMLS CUI [1])
Insulin Insulin regime Exogenous
Item
2. insulin, if obtained within 10 days of the onset of exogenous insulin therapy
boolean
C0021641 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
C0205228 (UMLS CUI [1,3])
Insulinoma antigen 2, human
Item
3. insulinoma antigen-2 (ia-2)
boolean
C1568433 (UMLS CUI [1])
zinc transporter
Item
4. zinc transporter- (znt)
boolean
C1608304 (UMLS CUI [1])
islet cell antibody
Item
5. islet-cell antibodies (ica).
boolean
C0063900 (UMLS CUI [1])
Insulin C-peptide measurement Peak Stimulated | Meal Mixed Tolerance test
Item
4. peak stimulated c-peptide level >= 0.2 pmol/ml following a mixed-meal tolerance test (mmtt) conducted at least 21 days from diagnosis and within 37 days of randomization
boolean
C0202100 (UMLS CUI [1,1])
C0444505 (UMLS CUI [1,2])
C1948023 (UMLS CUI [1,3])
C1998602 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C0201777 (UMLS CUI [2,3])
Informed Consent | Assent Minor
Item
5. signed informed consent (and informed assent of minor, if applicable).
boolean
C0021430 (UMLS CUI [1])
C1879749 (UMLS CUI [2,1])
C0026193 (UMLS CUI [2,2])
severe reaction Monoclonal Antibodies human | severe reaction Antibodies, Monoclonal, Humanized | severe reaction Monoclonal Antibodies mouse | anaphylaxis Monoclonal Antibodies human | anaphylaxis Antibodies, Monoclonal, Humanized | anaphylaxis Monoclonal Antibodies mouse
Item
1. severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
boolean
C3242604 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
C0086418 (UMLS CUI [1,3])
C3242604 (UMLS CUI [2,1])
C2985546 (UMLS CUI [2,2])
C3242604 (UMLS CUI [3,1])
C0003250 (UMLS CUI [3,2])
C0026809 (UMLS CUI [3,3])
C0002792 (UMLS CUI [4,1])
C0003250 (UMLS CUI [4,2])
C0086418 (UMLS CUI [4,3])
C0002792 (UMLS CUI [5,1])
C2985546 (UMLS CUI [5,2])
C0002792 (UMLS CUI [6,1])
C0003250 (UMLS CUI [6,2])
C0026809 (UMLS CUI [6,3])
Malignant Neoplasms | Cardiovascular Diseases Serious Uncontrolled | nervous system disorder | Lung diseases | Kidney Diseases | Gastrointestinal Diseases | Dyslipidemias Significant
Item
2. history of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
boolean
C0006826 (UMLS CUI [1])
C0007222 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0242339 (UMLS CUI [7,1])
C0750502 (UMLS CUI [7,2])
Bacterial Infections Serious | Virus Diseases | Mycoses | Opportunistic Infections
Item
3. any history of recent serious bacterial, viral, fungal, or other opportunistic infections
boolean
C0004623 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C0029118 (UMLS CUI [4])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
4. have serologic evidence of current or past hiv (human immunodeficiency virus), hepatitis b, or hepatitis c
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
QUANTIFERON-TB GOLD Test Positive | H/O: tuberculosis | Tuberculosis infection
Item
5. positive quantiferon tuberculosis (tb) test, history of tb, or active tb infection
boolean
C1875713 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0455460 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
Epstein-Barr Virus Infections | Epstein-Barr Virus Viral Load Measurement whole blood
Item
6. active infection with epstein-barr virus (ebv) as defined by ebv viral load >=10,000 copies per ml of whole blood
boolean
C0149678 (UMLS CUI [1])
C3274388 (UMLS CUI [2,1])
C0370231 (UMLS CUI [2,2])
Cytomegalovirus Infections | Cytomegalovirus Viral Load Measurement whole blood
Item
7. active infection with cytomegalovirus (cmv) as defined by cmv viral load >= 10,000 copies per ml of whole blood
boolean
C0010823 (UMLS CUI [1])
C3274383 (UMLS CUI [2,1])
C0370231 (UMLS CUI [2,2])
Liver diseases | Elevated liver enzymes | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement
Item
8. diagnosis of liver disease or elevated hepatic enzymes, as defined by alanine aminotransferase (alt), aspartate aminotransferase (ast), or both > 1.5 x the upper limit of age-determined normal (uln) or total bilirubin > uln
boolean
C0023895 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201913 (UMLS CUI [5])
Therapeutic procedure Causing Diabetes Mellitus, Insulin-Dependent Changed status Significant | Therapeutic procedure Causing Immunity Changed status Significant
Item
9. current or prior treatment that is known to cause a significant, ongoing change in the course of t1d or immunologic status
boolean
C0087111 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0011854 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C0750502 (UMLS CUI [1,5])
C0087111 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0020964 (UMLS CUI [2,3])
C0443172 (UMLS CUI [2,4])
C0750502 (UMLS CUI [2,5])
Pharmaceutical Preparations Therapeutic procedure Hyperglycemia | Insulin | Metformin | Sulfonylurea | Glinide | Thiazolidinediones | exenatide | liraglutide | Dipeptidyl-Peptidase IV Inhibitors | Amylin
Item
10. current or prior (within last 30 days) use of drugs other than insulin to treat hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, dpp-iv inhibitors, or amylin)
boolean
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0020456 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C3536898 (UMLS CUI [4])
C2266929 (UMLS CUI [5])
C1257987 (UMLS CUI [6])
C0167117 (UMLS CUI [7])
C1456408 (UMLS CUI [8])
C1827106 (UMLS CUI [9])
C0063684 (UMLS CUI [10])
Pharmaceutical Preparations Affecting glucose tolerance | Atypical antipsychotic | Phenytoin | Niacin
Item
11. current use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0178665 (UMLS CUI [1,3])
C1276996 (UMLS CUI [2])
C0031507 (UMLS CUI [3])
C0027996 (UMLS CUI [4])
Hematological abnormality
Item
12. any of the following hematologic abnormalities, confirmed by repeat tests:
boolean
C0850715 (UMLS CUI [1])
White Blood Cell Count procedure
Item
1. white blood count <3,000/microl or >14,000/microl
boolean
C0023508 (UMLS CUI [1])
Lymphocyte Count measurement
Item
2. lymphocyte count <500/microl
boolean
C0200635 (UMLS CUI [1])
Platelet Count measurement | Hemoglobin measurement
Item
3. platelet count <150,000 /microl hemoglobin <.5 g/dl
boolean
C0032181 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Neutrophil count
Item
4. neutrophil count <2,000 cells/microl.
boolean
C0200633 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
13. females who are pregnant, lactating, or planning on pregnancy during the 2- year study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Autoimmune Diseases | Thyroid Diseases Stable | Celiac Disease
Item
14. history or diagnoses of other autoimmune diseases with the exception of stable thyroid or celiac disease
boolean
C0004364 (UMLS CUI [1])
C0040128 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0007570 (UMLS CUI [3])
Substance abuse problem
Item
15. history of alcohol, drug or chemical abuse within 1 year prior to screening
boolean
C0740858 (UMLS CUI [1])
Compliance behavior Limited
Item
16. any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial Risk Increased
Item
17. prior participation in a clinical trial that could increase risks associated with this clinical trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0442805 (UMLS CUI [2,3])
Vaccines, Attenuated | Chickenpox Vaccine | Measles Vaccine | Mumps Vaccine | Rubella virus vaccine | Live Attenuated Influenza Vaccine | Bacillus Calmette-Guerin | Smallpox
Item
18. receipt of live vaccine (e.g. varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus calmette-guérin, and small pox) in the 6 weeks before randomization
boolean
C0042211 (UMLS CUI [1])
C0078048 (UMLS CUI [2])
C0025010 (UMLS CUI [3])
C0026782 (UMLS CUI [4])
C0035923 (UMLS CUI [5])
C3272757 (UMLS CUI [6])
C0085957 (UMLS CUI [7])
C0037354 (UMLS CUI [8])
Serum fasting LDL cholesterol measurement Lipid level High
Item
19. high lipid levels (fasting low-density lipoprotein (ldl) cholesterol >=160 mg/dl).
boolean
C0582830 (UMLS CUI [1,1])
C0428460 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])