ID

35800

Description

System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02290067

Link

https://clinicaltrials.gov/show/NCT02290067

Keywords

Versions (1)
  1. 3/24/19 3/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02290067

English

Eligibility Diabetes NCT02290067

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02290067
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 1 or type 2 diabetes and healthy subjects
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C1708335
signed and dated informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
for small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy) or insulin pump therapy (continuous subcutaneous insulin infusion)
Description

Diabetes Mellitus, Insulin-Dependent | Insulin regime With intensity | Insulin pump Therapy | Continuous subcutaneous infusion of insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0522510
UMLS CUI [3,1]
C1140609
UMLS CUI [3,2]
C0087111
UMLS CUI [4]
C0393124
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or lactation period
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe acute illness that in the opinion of the investigating physician might confound the results of the test or which could result in a risk to the patient caused by the test
Description

Acute illness Severe Interferes with Research results | Acute illness Severe Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C4061114
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0683954
UMLS CUI [2,1]
C4061114
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1444641
mental incapacity or language barriers precluding adequate compliance with the test procedures
Description

Mental handicap Excludes Compliance Tests | Language Barriers Exclude Compliance Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C0022885
UMLS CUI [2,1]
C0237167
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C1321605
UMLS CUI [2,4]
C0022885
severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the patient caused by the test
Description

Chronic disease Severe Interferes with Research results | Chronic disease Severe Study Subject Participation Status At risk | Exception Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0683954
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1444641
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011849
legal incompetence or limited legal competence
Description

Legal competency Lacking | Legal competency Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0680554
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0680554
UMLS CUI [2,2]
C0439801
dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)
Description

Coworker Clinical Study Sponsor | Coworker Clinical Research Center

Data type

boolean

Alias
UMLS CUI [1,1]
C0681088
UMLS CUI [1,2]
C2347796
UMLS CUI [2,1]
C0681088
UMLS CUI [2,2]
C0008972
UMLS CUI [2,3]
C1552416
for user performance evaluation: subjects having used the test systems before themselves or having participated in a study with these blood glucose monitoring systems
Description

Study Subject Participation Status | Blood glucose monitoring

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3669205
for system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease- or impaired hypoglycaemia awareness
Description

Coronary heart disease | Myocardial Infarction | Event cerebral | Peripheral arterial occlusive disease | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C0006104
UMLS CUI [4]
C1306889
UMLS CUI [5]
C0342317
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Similar models

Eligibility Diabetes NCT02290067

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02290067
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Healthy Volunteers
Item
subjects with type 1 or type 2 diabetes and healthy subjects
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C1708335 (UMLS CUI [3])
Informed Consent
Item
signed and dated informed consent form
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Insulin regime With intensity | Insulin pump Therapy | Continuous subcutaneous infusion of insulin
Item
for small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy) or insulin pump therapy (continuous subcutaneous insulin infusion)
boolean
C0011854 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C1140609 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0393124 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or lactation period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Acute illness Severe Interferes with Research results | Acute illness Severe Study Subject Participation Status At risk
Item
severe acute illness that in the opinion of the investigating physician might confound the results of the test or which could result in a risk to the patient caused by the test
boolean
C4061114 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C4061114 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
Mental handicap Excludes Compliance Tests | Language Barriers Exclude Compliance Tests
Item
mental incapacity or language barriers precluding adequate compliance with the test procedures
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,4])
C0237167 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0022885 (UMLS CUI [2,4])
Chronic disease Severe Interferes with Research results | Chronic disease Severe Study Subject Participation Status At risk | Exception Diabetes Mellitus
Item
severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the patient caused by the test
boolean
C0008679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0011849 (UMLS CUI [3,2])
Legal competency Lacking | Legal competency Limited
Item
legal incompetence or limited legal competence
boolean
C0680554 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0680554 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Coworker Clinical Study Sponsor | Coworker Clinical Research Center
Item
dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)
boolean
C0681088 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
C0681088 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C1552416 (UMLS CUI [2,3])
Study Subject Participation Status | Blood glucose monitoring
Item
for user performance evaluation: subjects having used the test systems before themselves or having participated in a study with these blood glucose monitoring systems
boolean
C2348568 (UMLS CUI [1])
C3669205 (UMLS CUI [2])
Coronary heart disease | Myocardial Infarction | Event cerebral | Peripheral arterial occlusive disease | Loss of hypoglycemic warning
Item
for system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease- or impaired hypoglycaemia awareness
boolean
C0010068 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C0006104 (UMLS CUI [3,2])
C1306889 (UMLS CUI [4])
C0342317 (UMLS CUI [5])
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