ID

29030

Description

A Study for Patients With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00447213

Link

https://clinicaltrials.gov/show/NCT00447213

Keywords

Versions (1)
  1. 2/21/18 2/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00447213

English

Eligibility Diabetes Mellitus, Type 1 NCT00447213

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus for at least 24 months
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
Description

Injection of insulin | Insulin Lispro | Insulin Aspart | Regular Insulin | Mixture

Data type

boolean

Alias
UMLS CUI [1]
C0199782
UMLS CUI [2]
C0293359
UMLS CUI [3]
C1708521
UMLS CUI [4]
C0021641
UMLS CUI [5]
C0439962
hba1c equal or less than 11 %
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study
Description

Non-smoker | Stopped smoking Duration | Tobacco use Discontinue Agreement | Smokeless Tobacco Use of

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0425310
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0543414
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0680240
UMLS CUI [4,1]
C0040338
UMLS CUI [4,2]
C1524063
satisfactory lung function results to meet the requirement of the study
Description

Pulmonary function tests Satisfactory

Data type

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0205410
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously received any form of inhaled insulin
Description

Insulin Inhaled

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0001559
require a daily total insulin dosage greater than 100 u
Description

Patient need for Insulin Dosage Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0332173
have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
Description

Asthma | Chronic Obstructive Airway Disease | Lung diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0024115
history or presence of liver disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
history or presence of kidney disease
Description

Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00447213

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus for at least 24 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Injection of insulin | Insulin Lispro | Insulin Aspart | Regular Insulin | Mixture
Item
injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
boolean
C0199782 (UMLS CUI [1])
C0293359 (UMLS CUI [2])
C1708521 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
C0439962 (UMLS CUI [5])
Glucohemoglobin measurement
Item
hba1c equal or less than 11 %
boolean
C0202054 (UMLS CUI [1])
Non-smoker | Stopped smoking Duration | Tobacco use Discontinue Agreement | Smokeless Tobacco Use of
Item
nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study
boolean
C0337672 (UMLS CUI [1])
C0425310 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0543414 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0680240 (UMLS CUI [3,3])
C0040338 (UMLS CUI [4,1])
C1524063 (UMLS CUI [4,2])
Pulmonary function tests Satisfactory
Item
satisfactory lung function results to meet the requirement of the study
boolean
C0024119 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Insulin Inhaled
Item
previously received any form of inhaled insulin
boolean
C0021641 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
Patient need for Insulin Dosage Daily
Item
require a daily total insulin dosage greater than 100 u
boolean
C0686904 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
Asthma | Chronic Obstructive Airway Disease | Lung diseases
Item
have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
boolean
C0004096 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
Liver disease
Item
history or presence of liver disease
boolean
C0023895 (UMLS CUI [1])
Kidney Disease
Item
history or presence of kidney disease
boolean
C0022658 (UMLS CUI [1])
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