Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
subject (or parent/guardian) willing and able to sign an informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Age
Item
age 8-25 (inclusive) years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
recently diagnosed with t1dm
boolean
C0011854 (UMLS CUI [1])
Basal insulin C-peptide measurement
Item
basal c-peptide ≥ 0.2 pmol/ml
boolean
C0650607 (UMLS CUI [1,1])
C0202100 (UMLS CUI [1,2])
Autoantibody Relationship Diabetes Mellitus | Autoantibody positive Quantity
Item
positive for at least one diabetes-related autoantibody
boolean
C0004358 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0853878 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Subject Diary Completion
Item
ability and consent to comply with completion of patient diary
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Serum Hematologic Test Normal | Serum chemistry test Normal
Item
no significant abnormalities in serum hematology, serum chemistry
boolean
C0229671 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0236613 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Normal urinalysis
Item
no significant abnormalities in urinalysis
boolean
C0749920 (UMLS CUI [1])
ECG normal
Item
no significant abnormalities in ecg
boolean
C0522054 (UMLS CUI [1])
Childbearing Potential Pregnancy Absent | Childbearing Potential Breast Feeding Absent
Item
for women of child bearing potential, non-pregnant, non-lactating female patients
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Immunoglobulin A deficiency
Item
iga deficient subjects
boolean
C0162538 (UMLS CUI [1])
Vaccines | Vaccines, Attenuated
Item
subjects who have received an active/ live virus vaccine within 4 weeks of the screening date
boolean
C0042210 (UMLS CUI [1])
C0042211 (UMLS CUI [2])
Steroid therapy | Immunosuppressive Agents | Cytostatic Agents
Item
subjects who have received treatment with corticosteroid medication within 2 months prior to screening or any immunosuppressant or cytostatic agent within 6 months prior to screening
boolean
C0149783 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0010858 (UMLS CUI [3])
Immediate hypersensitivity Severe Plasma Product | Anaphylaxis Plasma Product
Item
individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products
boolean
C0020523 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4521445 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C4521445 (UMLS CUI [2,2])
Comorbidity Clinical Significance
Item
clinically significant intercurrent illnesses
boolean
C0009488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Influence Glucose tolerance
Item
current use of any medication known to influence glucose tolerance
boolean
C0013227 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0178665 (UMLS CUI [1,3])
Metformin | Sulfonylureas | Glinides | Thiazolidinediones | exenatide | liraglutide | Dipeptidyl-Peptidase IV Inhibitors | Amylin
Item
current or prior (within the last 60 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, dpp-iv inhibitors or amylin.
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C3537178 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
C1456408 (UMLS CUI [6])
C1827106 (UMLS CUI [7])
C0063684 (UMLS CUI [8])