ID

43052

Description

Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus.; ODM derived from: https://clinicaltrials.gov/show/NCT00063128

Link

https://clinicaltrials.gov/show/NCT00063128

Keywords

Versions (2)
  1. 8/29/16 8/29/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00063128

English

Eligibility Diabetes Mellitus, Type 1 NCT00063128

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
you are at least 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
you have had type 1 diabetes for at least 2 years.
Description

Insulin-Dependent Diabetes Mellitus disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
you are injecting insulin lispro (humalog), an insulin lispro mixture (humalog mixture), regular human insulin mixture (humulin mixture) before meals using a syringe or injection pen, not an insulin pump.
Description

Injection ante cibus | Insulin Lispro | Humalog | Insulin Lispro Mixture | Humalog Mixture | Regular Human Insulin Mixture | Humulin Mixture | Syringe | Pen - injection | Insulin pump

Data type

boolean

Alias
UMLS CUI [1,1]
C1828121
UMLS CUI [1,2]
C1550738
UMLS CUI [2]
C0293359
UMLS CUI [3]
C0528249
UMLS CUI [4,1]
C0293359
UMLS CUI [4,2]
C0439962
UMLS CUI [5,1]
C0528249
UMLS CUI [5,2]
C0439962
UMLS CUI [6,1]
C0795635
UMLS CUI [6,2]
C0439962
UMLS CUI [7,1]
C3538423
UMLS CUI [7,2]
C0439962
UMLS CUI [8]
C0039142
UMLS CUI [9]
C3273588
UMLS CUI [10]
C1140609
if you are female and could become pregnant, you test negative for pregnancy based on blood test at the beginning of the study, do not intend to become pregnant, and agree to use a form of birth control approved by the investigator during the study.
Description

Pregnancy Pregnancy blood test Negative | Pregnancy, Planned | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0850355
UMLS CUI [1,3]
C1513916
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0700589
you have not smoked for at least 1 year, and you agree not to smoke or use smokeless tobacco during the study.
Description

Tobacco use Duration | Readiness to stop tobacco use | Smokeless Tobacco Use of

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C3873643
UMLS CUI [3,1]
C0040338
UMLS CUI [3,2]
C1524063
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
you have used an experimental drug during the last 30 days or have ever taken part in a study of any type of inhaled insulin.
Description

Investigational New Drugs | Study Subject Participation Status | Insulin Inhalation

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0205535
you have a history of asthma or allergies.
Description

Asthma | Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0020517
you have a chronic cough.
Description

Chronic cough

Data type

boolean

Alias
UMLS CUI [1]
C0010201
you have had a kidney transplant, are on dialysis, or have poor kidney function.
Description

Kidney Transplantation | Dialysis | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
UMLS CUI [3]
C1565489
you have a history of chest pain, heart attack, or you have a heart condition that limits your physical activity due to discomfort.
Description

Chest Pain | Myocardial Infarction | Heart condition Limiting Physical activity Due to Discomfort

Data type

boolean

Alias
UMLS CUI [1]
C0008031
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C3842523
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0026606
UMLS CUI [3,4]
C0678226
UMLS CUI [3,5]
C0231218
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00063128

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
you are at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus disease length
Item
you have had type 1 diabetes for at least 2 years.
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Injection ante cibus | Insulin Lispro | Humalog | Insulin Lispro Mixture | Humalog Mixture | Regular Human Insulin Mixture | Humulin Mixture | Syringe | Pen - injection | Insulin pump
Item
you are injecting insulin lispro (humalog), an insulin lispro mixture (humalog mixture), regular human insulin mixture (humulin mixture) before meals using a syringe or injection pen, not an insulin pump.
boolean
C1828121 (UMLS CUI [1,1])
C1550738 (UMLS CUI [1,2])
C0293359 (UMLS CUI [2])
C0528249 (UMLS CUI [3])
C0293359 (UMLS CUI [4,1])
C0439962 (UMLS CUI [4,2])
C0528249 (UMLS CUI [5,1])
C0439962 (UMLS CUI [5,2])
C0795635 (UMLS CUI [6,1])
C0439962 (UMLS CUI [6,2])
C3538423 (UMLS CUI [7,1])
C0439962 (UMLS CUI [7,2])
C0039142 (UMLS CUI [8])
C3273588 (UMLS CUI [9])
C1140609 (UMLS CUI [10])
Pregnancy Pregnancy blood test Negative | Pregnancy, Planned | Contraceptive methods
Item
if you are female and could become pregnant, you test negative for pregnancy based on blood test at the beginning of the study, do not intend to become pregnant, and agree to use a form of birth control approved by the investigator during the study.
boolean
C0032961 (UMLS CUI [1,1])
C0850355 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0032992 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Tobacco use Duration | Readiness to stop tobacco use | Smokeless Tobacco Use of
Item
you have not smoked for at least 1 year, and you agree not to smoke or use smokeless tobacco during the study.
boolean
C0543414 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C3873643 (UMLS CUI [2])
C0040338 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Study Subject Participation Status | Insulin Inhalation
Item
you have used an experimental drug during the last 30 days or have ever taken part in a study of any type of inhaled insulin.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0021641 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
Asthma | Hypersensitivity
Item
you have a history of asthma or allergies.
boolean
C0004096 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
Chronic cough
Item
you have a chronic cough.
boolean
C0010201 (UMLS CUI [1])
Kidney Transplantation | Dialysis | Renal Insufficiency
Item
you have had a kidney transplant, are on dialysis, or have poor kidney function.
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
Chest Pain | Myocardial Infarction | Heart condition Limiting Physical activity Due to Discomfort
Item
you have a history of chest pain, heart attack, or you have a heart condition that limits your physical activity due to discomfort.
boolean
C0008031 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C3842523 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0026606 (UMLS CUI [3,3])
C0678226 (UMLS CUI [3,4])
C0231218 (UMLS CUI [3,5])
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