ID

37307

Description

Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System; ODM derived from: https://clinicaltrials.gov/show/NCT02073058

Link

https://clinicaltrials.gov/show/NCT02073058

Keywords

  1. 7/15/19 7/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 15, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 1 Diabetes NCT02073058

Eligibility Type 1 Diabetes NCT02073058

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject must be at least 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
Description

Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
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.
Description

Patient need for Insulin regime | Insulin pump | Insulin injection multiple daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0557978
UMLS CUI [2]
C1140609
UMLS CUI [3,1]
C0199782
UMLS CUI [3,2]
C0439064
UMLS CUI [3,3]
C0332173
4. subject must be able to read and understand english.
Description

Able to read English Language | Language comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
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.
Description

Adherence Instructions Study Site | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C1442085
UMLS CUI [1,3]
C2825164
UMLS CUI [2]
C0525058
6. subject must be available to participate in all study visits.
Description

Participation Trial Visits All

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C1704705
UMLS CUI [1,3]
C0444868
7. subject must be willing and able to provide written signed and dated informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
Description

Allergy to adhesive | Hypersensitivity Isopropyl Alcohol

Data type

boolean

Alias
UMLS CUI [1]
C1635164
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0022237
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).
Description

Pregnancy | Trying to conceive | Contraceptive methods Unwilling | Contraceptive methods Unable

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0420843
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0558080
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C1299582
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.
Description

Skin lesion Application site | Cicatrization Application site | Erythema Application site | Communicable Disease Application site | Edema Application site | Interference Device placement | Interference Glucose measurement interstitial

Data type

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0229986
UMLS CUI [2,1]
C0008767
UMLS CUI [2,2]
C0229986
UMLS CUI [3,1]
C0041834
UMLS CUI [3,2]
C0229986
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0229986
UMLS CUI [5,1]
C0013604
UMLS CUI [5,2]
C0229986
UMLS CUI [6,1]
C0521102
UMLS CUI [6,2]
C0021107
UMLS CUI [7,1]
C0521102
UMLS CUI [7,2]
C0337438
UMLS CUI [7,3]
C0596790
4. subject currently is participating in another clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
5. subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
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:
Description

Medical condition Interferes with Clinical Trial | Medical condition At risk Patient safety | Medical condition At risk Research Personnel

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0035173
• history of hiv, hepatitis b or c
Description

HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
7. subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding.
Description

Medical condition Increases Bleeding risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C3251812
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.
Description

X-ray Appointment Scheduled | MRI Appointment Scheduled | CT Appointment Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0034571
UMLS CUI [1,2]
C0003629
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0003629
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C0040405
UMLS CUI [3,2]
C0003629
UMLS CUI [3,3]
C0205539
9. subject is unsuitable for participation due to any other cause as determined by the investigator.
Description

Study Subject Participation Status Inappropriate | Etiology Any

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1552551

Similar models

Eligibility Type 1 Diabetes NCT02073058

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])

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