ID

29091

Description

Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00964574

Link

https://clinicaltrials.gov/show/NCT00964574

Keywords

Versions (1)
  1. 2/23/18 2/23/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 23, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00964574

English

Eligibility Diabetes Mellitus, Type 1 NCT00964574

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
Description

Diabetes Mellitus, Insulin-Dependent | Patient need for Insulin regime Basal | Patient need for Insulin regime Bolus

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0557978
UMLS CUI [2,3]
C0650607
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0557978
UMLS CUI [3,3]
C1511237
6.5 <=hba1c <= 11% at visit 1
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
bmi <35 kg/m²
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
provision of signed and dated informed consent prior to any study procedures
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ability and willingness to complete study diaries and questionnaires
Description

Subject Diary Completion | Questionnaires Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
Description

Blood Glucose Self-Monitoring | Insulin Self-injection aid Use of

Data type

boolean

Alias
UMLS CUI [1]
C0005803
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C3880392
UMLS CUI [2,3]
C1524063
a negative pregnancy test for all females of childbearing potential.
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to insulin glulisine, insulin glargine or one of their excipients
Description

Hypersensitivity Insulin Glulisine | Hypersensitivity Insulin Glargine | Hypersensitivity Insulin Glulisine Excipient | Hypersensitivity Insulin Glargine Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1313386
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0907402
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1313386
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0907402
UMLS CUI [4,3]
C0015237
pregnant women
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
active proliferative diabetic retinopathy
Description

Proliferative diabetic retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0154830
impaired hepatic or renal function
Description

Liver Dysfunction | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status Aspect Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1879746
UMLS CUI [1,3]
C1524062
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00964574

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Patient need for Insulin regime Basal | Patient need for Insulin regime Bolus
Item
patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
boolean
C0011854 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0650607 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0557978 (UMLS CUI [3,2])
C1511237 (UMLS CUI [3,3])
Glucohemoglobin measurement
Item
6.5 <=hba1c <= 11% at visit 1
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
bmi <35 kg/m²
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
provision of signed and dated informed consent prior to any study procedures
boolean
C0021430 (UMLS CUI [1])
Subject Diary Completion | Questionnaires Completion
Item
ability and willingness to complete study diaries and questionnaires
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Blood Glucose Self-Monitoring | Insulin Self-injection aid Use of
Item
demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
boolean
C0005803 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C3880392 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
Childbearing Potential Pregnancy test negative
Item
a negative pregnancy test for all females of childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Insulin Glulisine | Hypersensitivity Insulin Glargine | Hypersensitivity Insulin Glulisine Excipient | Hypersensitivity Insulin Glargine Excipient
Item
hypersensitivity to insulin glulisine, insulin glargine or one of their excipients
boolean
C0020517 (UMLS CUI [1,1])
C1313386 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1313386 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0907402 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Proliferative diabetic retinopathy
Item
active proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1])
Liver Dysfunction | Renal Insufficiency
Item
impaired hepatic or renal function
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Study Subject Participation Status Aspect Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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