Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Insulin regime Injection Multiple Daily | Insulin regime Continuous subcutaneous infusion of insulin
Item
have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy
boolean
C0011854 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
C0557978 (UMLS CUI [3,1])
C0393124 (UMLS CUI [3,2])
Injection of insulin Absent | Infusion set for insulin pump Absent
Item
willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear
boolean
C0199782 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2242090 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Blood glucose meter | Blood Glucose Self-Monitoring
Item
willing to use only the blood glucose meter(s) provided to them for self-monitoring of blood glucose (smbg) during sensor wear
boolean
C0472226 (UMLS CUI [1])
C0005803 (UMLS CUI [2])
Participation Clinic Session | Blood glucose determination by fingerstick Quantity | Blood draw Quantity
Item
willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration
boolean
C0679823 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C1883016 (UMLS CUI [1,3])
C2022094 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0005834 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Blood glucose determination by fingerstick Quantity Home
Item
willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes)
boolean
C2022094 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0442519 (UMLS CUI [1,3])
Avoidance Acetaminophen
Item
willing to refrain from the use of acetaminophen during the sensor insertion period and for at least 24-hours prior to sensor insertion
boolean
C0870186 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
MRI Scan Absent | CT scan Absent | X-ray Absent
Item
willing not to schedule a magnetic resonance (mri) scan, computed tomography (ct) scan, or x-ray, for the duration of the study
boolean
C0917711 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0034571 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Able to speak English Language | Able to read English Language | Able to write English Language
Item
able to speak, read, and write english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Skin change Excludes Sensor | Dermatologic disorders Exclude Sensor | Psoriasis Extensive | Burns | Sunburn Severe | Eczema Extensive | Cicatrization Extensive | Tattoo Extensive | Dermatitis Herpetiformis
Item
have extensive skin changes/diseases that preclude wearing the sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
boolean
C1399787 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0183210 (UMLS CUI [1,3])
C0037274 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0183210 (UMLS CUI [2,3])
C0033860 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
C0006434 (UMLS CUI [4])
C0038814 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0013595 (UMLS CUI [6,1])
C0205231 (UMLS CUI [6,2])
C0008767 (UMLS CUI [7,1])
C0205231 (UMLS CUI [7,2])
C1366940 (UMLS CUI [8,1])
C0205231 (UMLS CUI [8,2])
C0011608 (UMLS CUI [9])
Hypersensitivity Adhesive Medical
Item
subjects who have a known allergy to medical-grade adhesives
boolean
C0020517 (UMLS CUI [1,1])
C0001516 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
Pregnancy Pregnancy test positive
Item
are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion
boolean
C0032961 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
Hematocrit level
Item
have a hematocrit that is less than 30%, or greater than 55%
boolean
C0518014 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study)
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Condition Interferes with Study Subject Participation Status | Condition High risk Venous blood sample Handling | Hepatitis B | Hepatitis C
Item
have any condition that, in the opinion of the investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis b or c)
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0444255 (UMLS CUI [2,3])
C0037793 (UMLS CUI [2,4])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])