Eligibility Type 1 Diabetes NCT02073058

1 Formulários

StudyEvent: Eligibility
1. Eligibility Type 1 Diabetes NCT02073058

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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])

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Eligibility Type 1 Diabetes NCT02073058