Age
Item
male or female, age 18-75
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes diagnosed for at least 1 year
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Oral medication Dosage Stable | Pharmaceutical Preparation Single | Pharmaceutical Preparations Combined
Item
treatment with stable doses of oral agents (alone or in combination) for at least 2 months
boolean
C0175795 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0205195 (UMLS CUI [3,2])
Poor glycemic control | Glucohemoglobin measurement | Sulfonylurea Maximum Tolerated Dose | Metformin Maximum Tolerated Dose | Thiazolidinedione Maximum Tolerated Dose
Item
inadequate glycemic control (hemoglobin a1c ≥ 7.5%) on maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione
boolean
C0342299 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
C0038766 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C1257987 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
Insulin use chronic | Therapeutic procedure Gestational Diabetes | hospitalization length of stay
Item
no past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
boolean
C0240016 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
C3694481 (UMLS CUI [3])
Glucohemoglobin measurement
Item
hemoglobin a1c between 7.5% and 12%
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 20 and 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Insulin use chronic | Therapeutic procedure Gestational Diabetes
Item
current or previous chronic use of insulin (other than for treatment of gestational diabetes)
boolean
C0240016 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent | Insulin-Dependent Diabetes Mellitus Suspicion Clinical
Item
history of confirmed (or clinical suspicion of) type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0242114 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Childbearing Potential Sexually active | Childbearing Potential Contraceptive methods Inadequate
Item
female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
current pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication Insulin regime | Insulin regime Indication Lacking
Item
subjects for whom insulin therapy is contraindicated or for whom, in the opinion of the investigator, therapy with insulin is not indicated
boolean
C1301624 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Proliferative diabetic retinopathy Advanced
Item
subjects with advanced proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Night shift worker | Meal Daily Consistent | Meal Plan Unable
Item
subjects who work night shifts or who are unable to stay on a consistent daily meal schedule
boolean
C0555008 (UMLS CUI [1])
C1998602 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C1998602 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Kidney Disease Clinical Significance | Liver disease | Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease Major Clinical Significance | Implementation Study Protocol Difficult | Interpretation Data Difficult
Item
history of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.
boolean
C0022658 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0442893 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C2826293 (UMLS CUI [6,3])
C1708476 (UMLS CUI [7,1])
C2348563 (UMLS CUI [7,2])
C0332218 (UMLS CUI [7,3])
C0459471 (UMLS CUI [8,1])
C1511726 (UMLS CUI [8,2])
C0332218 (UMLS CUI [8,3])
Pharmaceutical Preparations Interferes with Glucose metabolism
Item
subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])