Diabetes Mellitus, Insulin-Dependent
Item
diagnosis of type 1a diabetes mellitus based on ada criteria
boolean
C0011854 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus disease length
Item
≤5 years since t1d was diagnosed
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Age | Diabetes Mellitus, Insulin-Dependent
Item
≤ 40 years of age at the time of diagnosis of type 1a diabetes
boolean
C0001779 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
Antibodies Present
Item
presence of antibodies to at least one of the following antigens:
boolean
C0003241 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Insulin Antibodies | GAD-65 Antibodies | IA-2 Antibodies
Item
insulin, gad-65, or ia-2
boolean
C0021644 (UMLS CUI [1])
C0910436 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0380315 (UMLS CUI [3,1])
C0003241 (UMLS CUI [3,2])
fasting C-peptide level Detectable
Item
detectable fasting c-peptide level
boolean
C2208720 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
Insulin C-peptide increased | Meal Mixed Tolerance test
Item
c-peptide increase during screening mixed meal tolerance test with a minimal stimulated value of ≥ 0.2 pmol/ml
boolean
C0861021 (UMLS CUI [1])
C1998602 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
C0201777 (UMLS CUI [2,3])
Antibodies Present | Insulin Antibodies | GAD-65 Antibodies | IA-2 Antibodies
Item
presence of antibodies to at least one of the following antigens: insulin, gad-65, or ia-2. if insulin antibody positive only, determination must be within 2 weeks of insulin initiation
boolean
C0003241 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0021644 (UMLS CUI [2])
C0910436 (UMLS CUI [3,1])
C0003241 (UMLS CUI [3,2])
C0380315 (UMLS CUI [4,1])
C0003241 (UMLS CUI [4,2])
Body mass index
Item
bmi > 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Blood Glucose control Unstable | Hypoglycemia Severe Episode Quantity | Assistance Patient need for
Item
unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days
boolean
C0005802 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0020615 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332189 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C1269765 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Insulin Inhalation
Item
current use of inhalable insulin
boolean
C0021641 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
Immunotherapy Insulin-Dependent Diabetes Mellitus
Item
previous immunotherapy for t1d
boolean
C0021083 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Investigational New Drug Insulin-Dependent Diabetes Mellitus | Investigational Medical Device Insulin-Dependent Diabetes Mellitus
Item
administration of an experimental agent for t1d at any time or use of an experimental device for t1d within 30 days prior to screening, unless approved by the medical monitor
boolean
C0013230 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0011854 (UMLS CUI [2,2])
Organ Transplantation | Islets of Langerhans Transplantation
Item
history of any organ transplant, including islet cell transplant
boolean
C0029216 (UMLS CUI [1])
C0079646 (UMLS CUI [2])