Diabetes Mellitus, Insulin-Dependent
Item
subject must have a diagnosis of type 1 diabetes mellitus based on the ada criteria
boolean
C0011854 (UMLS CUI [1])
Screening Required | At initial diagnosis Insulin-Dependent Diabetes Mellitus
Item
subject must be screened between 2 and 20 weeks from initial t1dm diagnosis
boolean
C0220908 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C4071762 (UMLS CUI [2,1])
C0011854 (UMLS CUI [2,2])
Age
Item
subject must be between the ages of 12 and 35 (inclusive)
boolean
C0001779 (UMLS CUI [1])
Autoantibodies Quantity Diabetes Related | Anti-GAD antibody | IA-2 antibody
Item
subject must have at least one diabetes-related autoantibody present (either gad or ia-2)
boolean
C0004358 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0011847 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C1167897 (UMLS CUI [2])
C0528414 (UMLS CUI [3])
Beta-Cell Function | C-peptide measurement
Item
subject must have some beta cell function as determined by c-peptide testing
boolean
C4055385 (UMLS CUI [1])
C0202100 (UMLS CUI [2])
Compliance behavior Diabetes mellitus management | Maintenance Blood glucose normal
Item
subject must be willing to comply with "intensive diabetes management" as directed by the investigator with the goal of maintaining blood glucose as close to normal as possible
boolean
C1321605 (UMLS CUI [1,1])
C0948092 (UMLS CUI [1,2])
C0024501 (UMLS CUI [2,1])
C0580545 (UMLS CUI [2,2])
Protocol Compliance
Item
subject must be willing to comply with the schedule of study visits and protocol requirements
boolean
C0525058 (UMLS CUI [1])
Body mass index
Item
subject has body mass index (bmi) ≥ 30
boolean
C1305855 (UMLS CUI [1])
Retinal Disease
Item
subject has evidence of retinopathy at baseline
boolean
C0035309 (UMLS CUI [1])
Serum lipids high Abnormal
Item
subject has abnormally high lipid levels
boolean
C0428465 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Abnormal blood pressure
Item
subject has abnormal blood pressure
boolean
C0005826 (UMLS CUI [1])
Serum creatinine abnormal
Item
subject has abnormal serum creatinine
boolean
C0438243 (UMLS CUI [1])
Proteinuria
Item
subject has evidence of clinically significant proteinuria
boolean
C0033687 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
subject has diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Communicable Disease Severe Treated
Item
subject is being treated for severe active infection of any type
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
a female subject who is breast-feeding, pregnant, or intends to become pregnant during the study
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Medical condition Uncontrolled | Relationship Absent Diabetes Mellitus | Hematological Disease | Kidney Diseases | Liver diseases | Nervous system disorder | Heart Diseases | Respiration Disorders
Item
subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. hematologic, renal, hepatic, neurologic, cardiac, or respiratory)
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,3])
C0018939 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0018799 (UMLS CUI [7])
C0035204 (UMLS CUI [8])
Hypersensitivity Products Bovine | Hypersensitivity Products Porcine
Item
subject is allergic to bovine or porcine products
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C3667982 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C3665571 (UMLS CUI [2,3])
Malignant Neoplasms | Remission Absent
Item
subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years
boolean
C0006826 (UMLS CUI [1])
C0544452 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])