Age
Item
1. age 18 years or older;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin
Item
2. have been diagnosed with type 1 diabetes and are on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy;
boolean
C0011854 (UMLS CUI [1])
C0199782 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0393124 (UMLS CUI [3])
Absence Insulin injection Sensor Site | Absence Insulin Pump Administration Set Sensor Site
Item
3. willing not to inject insulin or wear an insulin pump infusion set within 3 inches from either sensor site;
boolean
C0332197 (UMLS CUI [1,1])
C0199782 (UMLS CUI [1,2])
C0872382 (UMLS CUI [1,3])
C0205145 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0181365 (UMLS CUI [2,2])
C0872382 (UMLS CUI [2,3])
C0205145 (UMLS CUI [2,4])
Participation Clinic Session | Fingerstick Quantity per hour | Blood draw Quantity per hour
Item
4. willing to participate in an 8-hour in-clinic session on study days 5, 10, and 15 and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the 8-hour duration of each of these in-clinic sessions;
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])
C0564385 (UMLS CUI [2,3])
C0005834 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0564385 (UMLS CUI [3,3])
Fingerstick Quantity per day Home environment
Item
5. willing to take a minimum of 6 fingersticks per day during home use;
boolean
C2022094 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0442519 (UMLS CUI [1,4])
Avoidance Acetaminophen
Item
6. willing to refrain from the use of acetaminophen during this study and for at least 24-hours prior to enrollment;
boolean
C0870186 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
Schedule MRI scan Absent | Schedule CT scan Absent | Schedule X-ray Absent
Item
7. willing not to schedule an magnetic resonance (mri) scan, computed tomography (ct) scan, x-ray, for the duration of the study;
boolean
C0030703 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0030703 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0030703 (UMLS CUI [3,1])
C0034571 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Able to speak English Language | Able to read English Language | Able to write English Language
Item
8. 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 changes Extensive Preventing Sensor | Dermatologic disorders Extensive Preventing Sensor | Psoriasis Extensive | Burns | Sunburn Severe | Eczema Extensive | Cicatrization Extensive | Tattoos Extensive | Dermatitis Herpetiformis
Item
1. 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])
C0205231 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0872382 (UMLS CUI [1,4])
C0037274 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0872382 (UMLS CUI [2,4])
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])
Allergy to adhesive
Item
2. subjects who have a known allergy to medical-grade adhesives;
boolean
C1635164 (UMLS CUI [1])
Pregnancy | Pregnancy test positive
Item
3. are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
Hematocrit level
Item
4. have a hematocrit that is less than 30%, or greater than 55%;
boolean
C0518014 (UMLS CUI [1])
Study Subject Participation Status
Item
5. 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])
Condition Interferes with Study Subject Participation Status | Condition At risk Venous blood sampling | Hepatitis B | Hepatitis C
Item
6. 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])
C1444641 (UMLS CUI [2,2])
C0190979 (UMLS CUI [2,3])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])