Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
1. diagnosis of type 1or type 2 diabetes mellitus for at least a year
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Insulin regime Stable | Injection Multiple Daily | Regular Insulin, Human | Short-Acting Insulin Mealtimes | Insulin, Long-Acting | Intermediate-acting insulin | Basal insulin
Item
2. stable insulin regimen for at least 3 months consisting of multiple daily injections of human regular or rapid acting insulin at meal times and long or intermediate acting insulin as basal. in this protocol multiple daily injections requires at least three injections daily.
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1533685 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0795635 (UMLS CUI [3])
C0356365 (UMLS CUI [4,1])
C0587119 (UMLS CUI [4,2])
C0304870 (UMLS CUI [5])
C0304869 (UMLS CUI [6])
C0650607 (UMLS CUI [7])
Insulin Total Dose U/day
Item
3. total daily insulin dose between 50 and 80 units.
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Thiazolidinediones | Sulfonylureas | alpha-Glucosidase Inhibitors Excluded | Meglitinide Excluded | Pramlintide Excluded | Exenatide Excluded | Dipeptidyl-Peptidase IV Inhibitors Excluded
Item
4. if patient is type 2, can be treated with metformin and/or a thiazolidinedione and/or a sulfonylurea, but other diabetes drugs including α-glucosidase inhibitors, meglitinides, pramlintide exenatide, and dpp-iv's are excluded.
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C1299007 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0065880 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0537551 (UMLS CUI [7,1])
C0332196 (UMLS CUI [7,2])
C0167117 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
C1827106 (UMLS CUI [9,1])
C0332196 (UMLS CUI [9,2])
Hemoglobin A1c measurement
Item
5. hba1c > 7.0% and < 9.0%.
boolean
C0474680 (UMLS CUI [1])
Hypoglycemia Major | Blood Glucose Control Unstable Prolonged
Item
1. recurrent major hypoglycemia or prolonged unstable blood glucose control (as judged by the investigator).
boolean
C0020615 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0005802 (UMLS CUI [2,1])
C2587213 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C0439590 (UMLS CUI [2,4])
Antidiabetics | alpha-Glucosidase Inhibitors | Meglitinide | Pramlintide | exenatide | Dipeptidyl-Peptidase IV Inhibitors | Metformin allowed | Thiazolidinediones allowed | Sulfonylureas allowed
Item
2. use of other diabetes drugs including α-glucosidase inhibitors, meglitinides, pramlintide, exenatide or dpp-iv inhibitors (metformin and/or a thiazolidinedione and/or a sulfonylurea are allowed).
boolean
C0935929 (UMLS CUI [1])
C1299007 (UMLS CUI [2])
C0065880 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
C1827106 (UMLS CUI [6])
C0025598 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C1257987 (UMLS CUI [8,1])
C0683607 (UMLS CUI [8,2])
C0038766 (UMLS CUI [9,1])
C0683607 (UMLS CUI [9,2])
Pharmacotherapy Affecting Blood glucose level | Non-Prescription Drugs Affecting Blood glucose level
Item
3. intend to use any other concomitant drug therapy (prescription or over-the-counter medications) that can affect blood glucose levels.
boolean
C0013216 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0428554 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0428554 (UMLS CUI [2,3])
Glucocorticoids, Systemic | Glucocorticoids
Item
4. have used systemic glucocorticoids within 1 month prior to screening or currently on glucocorticoids.
boolean
C3540777 (UMLS CUI [1])
C0017710 (UMLS CUI [2])
Substance Use Disorders
Item
5. have a history of drug or alcohol abuse within 1 year prior to screening visit.
boolean
C0038586 (UMLS CUI [1])
Cardiovascular Disease Study Subject Participation Status Excluded | Respiration Disorder Study Subject Participation Status Excluded | Liver disease Study Subject Participation Status Excluded | Kidney Disease Study Subject Participation Status Excluded | Gastrointestinal Disease Study Subject Participation Status Excluded | Nervous system disorder Study Subject Participation Status Excluded
Item
6. have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neurological disease that would, in the investigator's opinion, preclude safe participation in the study.
boolean
C0007222 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0035204 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0022658 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0017178 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C0332196 (UMLS CUI [5,3])
C0027765 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C0332196 (UMLS CUI [6,3])
Major surgery | Laparotomy | Thoracotomy | Orthopedic Procedure Open
Item
7. have a history of major surgery, e.g. laparotomy, thoracotomy, open orthopedic procedure, etc. within 3 months prior to screening visit.
boolean
C0679637 (UMLS CUI [1])
C0023038 (UMLS CUI [2])
C0039991 (UMLS CUI [3])
C0524852 (UMLS CUI [4,1])
C0175566 (UMLS CUI [4,2])
Neuropsychiatric syndrome
Item
8. evidence of significant neuropsychiatric disease.
boolean
C3203509 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Clinical Trial | Clinical Trial Surgical | Pharmaceutical Preparations Investigational
Item
9. have participated in a medical, surgical, or pharmaceutical investigational new drug/device study in the last 30 days or ≤ 5 half-lives of the investigational drug, whichever is longer, prior to screening visit.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C0008976 (UMLS CUI [4])
C0008976 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
C0013227 (UMLS CUI [6,1])
C1517586 (UMLS CUI [6,2])
Blood Donation Amount
Item
10. blood donation of 500 ml or more in the last 2 months prior to screening visit.
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Hematological Disease
Item
11. evidence of significant active hematological disease.
boolean
C0018939 (UMLS CUI [1])
Communicable Disease With Fever
Item
12. acute infection with fever.
boolean
C0009450 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Hemoglobin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
13. hemoglobin < 10 g/dl; ast, alt ≥ 1.5 times the upper reference limit at screening.
boolean
C0518015 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Systolic Pressure | Diastolic blood pressure
Item
14. uncontrolled treated/untreated hypertension (systolic blood pressure > 155 mmhg and diastolic blood pressure > 90 mmhg).
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Proliferative retinopathy | Disorder of macula of retina Treatment required for
Item
15. history of proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Mental handicap Preventing Comprehension | Comprehension Unwilling | Language Barrier Preventing Comprehension | Mental handicap Preventing Cooperation | Cooperation Unwilling | Language Barrier Preventing Cooperation
Item
16. mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
boolean
C1306341 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0162340 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0237167 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0162340 (UMLS CUI [3,3])
C1306341 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0392337 (UMLS CUI [4,3])
C0392337 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C0237167 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C0392337 (UMLS CUI [6,3])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
17. any condition that the investigator and/or sponsor feel would interfere with trial participation or evaluation of results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy
Item
18. pregnancy, breast-feeding, intention of becoming pregnant for female patients of child-bearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])