Informed Consent
Item
signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c between 7.0 and 9.0%
boolean
C0474680 (UMLS CUI [1])
Age
Item
18 - 75 years of age
boolean
C0001779 (UMLS CUI [1])
Standard Product Enteral
Item
currently receiving a standard enteral product
boolean
C1442989 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C1304890 (UMLS CUI [1,3])
Tube feeding Duration Anticipated
Item
anticipated duration on tube feeding at least one month
boolean
C0041281 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
Enteral Nutrition Support
Item
100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
boolean
C0014327 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
Life Expectancy
Item
anticipated life expectancy is more than or equal to 6 months
boolean
C0023671 (UMLS CUI [1])
Communicable Diseases Free of
Item
free of infections
boolean
C0009450 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
Absence Change of medication Affecting Blood Glucose
Item
no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose
boolean
C0332197 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0005802 (UMLS CUI [1,4])
Composition Investigational New Drugs Inappropriate | Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient
Item
composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
boolean
C0486616 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C1744706 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])
Composition Investigational New Drugs Inappropriate | Protein Restrictions Due to Medical condition | Fluid restriction Due to Medical condition | Electrolyte Restrictions Due to Medical condition
Item
composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
boolean
C0486616 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0033684 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C3843040 (UMLS CUI [2,4])
C0204700 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C3843040 (UMLS CUI [3,3])
C0013832 (UMLS CUI [4,1])
C0443288 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C3843040 (UMLS CUI [4,4])
Cardiovascular event
Item
significant cardiovascular event less than or equal to 2 weeks prior to study entry
boolean
C1320716 (UMLS CUI [1])
Major surgery
Item
major surgery less than or equal to 2 weeks prior to study entry
boolean
C0679637 (UMLS CUI [1])
Operative Surgical Procedures Planned
Item
pre-planned surgery during the study period
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Malignant Neoplasms | Melanoma | Skin Neoplasms Excluded
Item
active malignancy, including melanoma and excluding cutaneous malignancies
boolean
C0006826 (UMLS CUI [1])
C0025202 (UMLS CUI [2])
C0037286 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Severe dementia
Item
severe dementia
boolean
C3494652 (UMLS CUI [1])
Allergy to adhesive | Hypersensitivity Skin Disinfectants
Item
known allergies to medical grade adhesives and/or skin disinfectants
boolean
C1635164 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0012682 (UMLS CUI [2,3])
Octreotide
Item
taking octreotide
boolean
C0028833 (UMLS CUI [1])
Chronic infectious disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection
Item
chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv
boolean
C0151317 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
Study Subject Participation Status
Item
participation in a concomitant trial
boolean
C2348568 (UMLS CUI [1])