Age
Item
1. age 18 to 70 years;
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length
Item
2. have been diagnosed with type 1 diabetes at least 3 years;
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin
Item
3. have been treated on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy for at last 6 months;
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0393124 (UMLS CUI [2])
Administration of insulin Method unchanged
Item
4. willing not to switch method of insulin delivery (i.e., mdi to csii, or csii to mdi) while enrolled in this study;
boolean
C0199782 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Hemoglobin A1c measurement | HbA1c Point-of-Care Testing
Item
5. baseline a1c within 6.5% to 10.0% (may be determined by poc measurement, e.g., dca 2000 to assess this inclusion criterion);
boolean
C0474680 (UMLS CUI [1])
C0019018 (UMLS CUI [2,1])
C1319069 (UMLS CUI [2,2])
Insulin injection Multiple Daily | Insulin Dose Stable | Lantus Dose Stable | Insulin, Short-Acting | Humalog | NovoLog | Apidra
Item
6. patients on mdi should be on a stable dose of peak-less insulin (e.g., lantus) once or twice a day along with any rapid acting prandial insulin analog (e.g., humalog, novolog, or apidra);
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0876064 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0356365 (UMLS CUI [4])
C0528249 (UMLS CUI [5])
C0939412 (UMLS CUI [6])
C1654827 (UMLS CUI [7])
Absence Insulin injection Sensor Site | Absence Insulin Pump Administration Set Sensor Site
Item
7. willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;
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])
Use of Blood glucose meters | Blood Glucose Self-Monitoring
Item
8. willing to use only the blood glucose meter(s) provided to them for self-monitoring of blood glucose (smbg) during sensor wear;
boolean
C1524063 (UMLS CUI [1,1])
C0472226 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2])
Fingerstick Quantity per day Home environment | Fingerstick Quantity Calibration | Fingerstick Quantity Comparison
Item
9. willing to take a minimum of 4 fingersticks per day during home use (2 for calibration purposes, 2 for comparative purposes);
boolean
C2022094 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0442519 (UMLS CUI [1,4])
C2022094 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0006751 (UMLS CUI [2,3])
C2022094 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1707455 (UMLS CUI [3,3])
Avoidance Acetaminophen
Item
10. 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])
Schedule MRI scan Absent | Schedule CT scan Absent | Schedule X-ray Absent
Item
11. willing not to schedule a magnetic resonance (mri) scan, computed tomography (ct) scan, or 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
12. 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 | Allergy to adhesive | Pregnancy | Pregnancy test positive | Pregnancy, Planned | Hematocrit level | Study Subject Participation Status | Investigational New Drugs | Continuous glucose monitoring | Condition Interferes with Study Subject Participation Status | Condition At risk Venous blood sampling | Hepatitis B | Hepatitis C
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; 2. subjects who have a known allergy to medical-grade adhesives; 3. are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion or are planning to become pregnant during the course of study; 4. have a hematocrit that is less than 30%, or greater than 55%; 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); 6. have used cgm for 6 or more weeks (combined) during the 3 months prior to enrollment; 7. 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
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])
C1635164 (UMLS CUI [10])
C0032961 (UMLS CUI [11])
C0240802 (UMLS CUI [12])
C0032992 (UMLS CUI [13])
C0518014 (UMLS CUI [14])
C2348568 (UMLS CUI [15])
C0013230 (UMLS CUI [16])
C4523945 (UMLS CUI [17])
C0348080 (UMLS CUI [18,1])
C0521102 (UMLS CUI [18,2])
C2348568 (UMLS CUI [18,3])
C0348080 (UMLS CUI [19,1])
C1444641 (UMLS CUI [19,2])
C0190979 (UMLS CUI [19,3])
C0019163 (UMLS CUI [20])
C0019196 (UMLS CUI [21])