ID

19442

Description

Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control; ODM derived from: https://clinicaltrials.gov/show/NCT00688363

Link

https://clinicaltrials.gov/show/NCT00688363

Keywords

Versions (1)
  1. 1/3/17 1/3/17 -
Uploaded on

January 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00688363

English

Eligibility Type 2 Diabetes NCT00688363

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2-diabetes (ada/who-criteria)
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
conventional insulin therapy ( 1-3 daily injections of basal- and/or mixed insulin also in combination with oral agents.)
Description

Insulin regime conventional | Basal insulin | Insulin Mixed | oral medication | Daily Injection Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0439858
UMLS CUI [2]
C0650607
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0205430
UMLS CUI [4]
C0175795
UMLS CUI [5,1]
C0332173
UMLS CUI [5,2]
C1828121
UMLS CUI [5,3]
C1265611
age:> 40 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bmi:> 20 kg/m²
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired liver function, defined as > 2 times upper limit of normal
Description

Liver Dysfunction | Increased liver function

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0232743
impaired renal function defined liver enzymes as serum-creatinine > 1.3 mg/dl
Description

Renal Insufficiency | Measurement of liver enzyme | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0428321
UMLS CUI [3]
C0201976
gastro-intestinal diseases (disturbances, diagnoses)
Description

Gastrointestinal Diseases | Gastrointestinal Disturbances

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0232459
inability to perform study-related activities according to the present protocol
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
pregnancy not certainly excluded
Description

Pregnancy Possible

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332149
abuse of alcohol and/or other drugs
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
participation in other clinical trials during the past 3 month
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
threat to general state of health
Description

Risk General health

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0424575
intensified insulin therapy (at least 3 times rapid-acting insulin)
Description

Insulin regime intense | Rapid Acting Insulin Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0522510
UMLS CUI [2,1]
C0356365
UMLS CUI [2,2]
C0376249
frequent blood glucose self monitoring during the past 3 months (more than one 4-point glucose profile per week or more than one blood glucose/ urinary glucose test per day )
Description

Blood Glucose Self-Monitoring frequent | Blood glucose test per day Quantity | Urine glucose test per day Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0332183
UMLS CUI [2,1]
C0392201
UMLS CUI [2,2]
C0439505
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0004076
UMLS CUI [3,2]
C0439505
UMLS CUI [3,3]
C1265611
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Similar models

Eligibility Type 2 Diabetes NCT00688363

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2-diabetes (ada/who-criteria)
boolean
C0011860 (UMLS CUI [1])
Insulin regime conventional | Basal insulin | Insulin Mixed | oral medication | Daily Injection Quantity
Item
conventional insulin therapy ( 1-3 daily injections of basal- and/or mixed insulin also in combination with oral agents.)
boolean
C0557978 (UMLS CUI [1,1])
C0439858 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2])
C0021641 (UMLS CUI [3,1])
C0205430 (UMLS CUI [3,2])
C0175795 (UMLS CUI [4])
C0332173 (UMLS CUI [5,1])
C1828121 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Age
Item
age:> 40 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi:> 20 kg/m²
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver Dysfunction | Increased liver function
Item
impaired liver function, defined as > 2 times upper limit of normal
boolean
C0086565 (UMLS CUI [1])
C0232743 (UMLS CUI [2])
Renal Insufficiency | Measurement of liver enzyme | Creatinine measurement, serum
Item
impaired renal function defined liver enzymes as serum-creatinine > 1.3 mg/dl
boolean
C1565489 (UMLS CUI [1])
C0428321 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Gastrointestinal Diseases | Gastrointestinal Disturbances
Item
gastro-intestinal diseases (disturbances, diagnoses)
boolean
C0017178 (UMLS CUI [1])
C0232459 (UMLS CUI [2])
Protocol Compliance Unable
Item
inability to perform study-related activities according to the present protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy Possible
Item
pregnancy not certainly excluded
boolean
C0032961 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Substance Use Disorders
Item
abuse of alcohol and/or other drugs
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in other clinical trials during the past 3 month
boolean
C2348568 (UMLS CUI [1])
Risk General health
Item
threat to general state of health
boolean
C0035647 (UMLS CUI [1,1])
C0424575 (UMLS CUI [1,2])
Insulin regime intense | Rapid Acting Insulin Frequency
Item
intensified insulin therapy (at least 3 times rapid-acting insulin)
boolean
C0557978 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0356365 (UMLS CUI [2,1])
C0376249 (UMLS CUI [2,2])
Blood Glucose Self-Monitoring frequent | Blood glucose test per day Quantity | Urine glucose test per day Quantity
Item
frequent blood glucose self monitoring during the past 3 months (more than one 4-point glucose profile per week or more than one blood glucose/ urinary glucose test per day )
boolean
C0005803 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])
C0392201 (UMLS CUI [2,1])
C0439505 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0004076 (UMLS CUI [3,1])
C0439505 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
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