Age
Item
1. subject must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
2. subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Patient need for Insulin regime | Insulin pump | Insulin injection multiple daily
Item
3. subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment.
boolean
C0686904 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
C1140609 (UMLS CUI [2])
C0199782 (UMLS CUI [3,1])
C0439064 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
Able to read English Language | Language comprehension English Language
Item
4. subject must be able to read and understand english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Adherence Instructions Study Site | Protocol Compliance
Item
5. in the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
boolean
C1510802 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
Participation Trial Visits All
Item
6. subject must be available to participate in all study visits.
boolean
C0679823 (UMLS CUI [1,1])
C1704705 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Informed Consent
Item
7. subject must be willing and able to provide written signed and dated informed consent.
boolean
C0021430 (UMLS CUI [1])
Allergy to adhesive | Hypersensitivity Isopropyl Alcohol
Item
1. subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
boolean
C1635164 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0022237 (UMLS CUI [2,2])
Pregnancy | Trying to conceive | Contraceptive methods Unwilling | Contraceptive methods Unable
Item
2. subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).
boolean
C0032961 (UMLS CUI [1])
C0420843 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Skin lesion Application site | Cicatrization Application site | Erythema Application site | Communicable Disease Application site | Edema Application site | Interference Device placement | Interference Glucose measurement interstitial
Item
3. subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
boolean
C0037284 (UMLS CUI [1,1])
C0229986 (UMLS CUI [1,2])
C0008767 (UMLS CUI [2,1])
C0229986 (UMLS CUI [2,2])
C0041834 (UMLS CUI [3,1])
C0229986 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0229986 (UMLS CUI [4,2])
C0013604 (UMLS CUI [5,1])
C0229986 (UMLS CUI [5,2])
C0521102 (UMLS CUI [6,1])
C0021107 (UMLS CUI [6,2])
C0521102 (UMLS CUI [7,1])
C0337438 (UMLS CUI [7,2])
C0596790 (UMLS CUI [7,3])
Study Subject Participation Status
Item
4. subject currently is participating in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
Blood Donation
Item
5. subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
boolean
C0005794 (UMLS CUI [1])
Medical condition Interferes with Clinical Trial | Medical condition At risk Patient safety | Medical condition At risk Research Personnel
Item
6. subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. such conditions include but are not limited to:
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0035173 (UMLS CUI [3,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
• history of hiv, hepatitis b or c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Medical condition Increases Bleeding risk
Item
7. subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding.
boolean
C3843040 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C3251812 (UMLS CUI [1,3])
X-ray Appointment Scheduled | MRI Appointment Scheduled | CT Appointment Scheduled
Item
8. subject has x-ray, mri or ct appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
boolean
C0034571 (UMLS CUI [1,1])
C0003629 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0024485 (UMLS CUI [2,1])
C0003629 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0040405 (UMLS CUI [3,1])
C0003629 (UMLS CUI [3,2])
C0205539 (UMLS CUI [3,3])
Study Subject Participation Status Inappropriate | Etiology Any
Item
9. subject is unsuitable for participation due to any other cause as determined by the investigator.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])