ID

29052

Description

International Navigator Hypoglycaemia Study; ODM derived from: https://clinicaltrials.gov/show/NCT00843609

Link

https://clinicaltrials.gov/show/NCT00843609

Keywords

Versions (1)
  1. 2/22/18 2/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00843609

English

Eligibility Diabetes Mellitus, Type 1 NCT00843609

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject with type 1 diabetes (> 1year since diagnosis)
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
csii or mdi
Description

Continuous subcutaneous infusion of insulin | Injection of insulin Daily Dose Multiple

Data type

boolean

Alias
UMLS CUI [1]
C0393124
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C2348070
UMLS CUI [2,3]
C0439064
hba1c at inclusion < 7.5 %
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
no concomitant diseases that influence metabolic control
Description

Absence Comorbidity Influence Metabolic Control

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009488
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C1513158
no current use of cgm
Description

Blood glucose monitoring Continuous Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1820407
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has known allergy to medical grade adhesives
Description

Hypersensitivity Adhesives Medical

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001516
UMLS CUI [1,3]
C0205476
subject has a medical condition, which in the investigator's opinion, may compromise patient safety
Description

Medical condition compromises Patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
Description

Study Subject Participation Status | Glucose monitoring device Affecting Glucose measurement | Glucose monitoring device Affecting Blood glucose management | Investigational New Drugs Affecting Glucose measurement | Investigational New Drugs Affecting Blood glucose management

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0202048
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0337438
UMLS CUI [3,1]
C0202048
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1638311
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0337438
UMLS CUI [5,1]
C0013230
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1638311
subject is currently using another cgm device or has used real-time continuous glucose monitoring in the previous 4 weeks
Description

Blood glucose monitoring Continuous | Medical Device Other | Blood glucose monitoring Continuous Real Time

Data type

boolean

Alias
UMLS CUI [1,1]
C1820407
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0025080
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C1820407
UMLS CUI [3,2]
C0549178
UMLS CUI [3,3]
C1550177
subject is receiving peritoneal dialysis solutions containing icodextrin
Description

Peritoneal dialysis solution Containing Icodextrin

Data type

boolean

Alias
UMLS CUI [1,1]
C0353714
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0538727
female subject who is pregnant or planning to become pregnant within the planned study duration
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00843609

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
subject with type 1 diabetes (> 1year since diagnosis)
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Continuous subcutaneous infusion of insulin | Injection of insulin Daily Dose Multiple
Item
csii or mdi
boolean
C0393124 (UMLS CUI [1])
C0199782 (UMLS CUI [2,1])
C2348070 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
Glucohemoglobin measurement
Item
hba1c at inclusion < 7.5 %
boolean
C0202054 (UMLS CUI [1])
Absence Comorbidity Influence Metabolic Control
Item
no concomitant diseases that influence metabolic control
boolean
C0332197 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C1513158 (UMLS CUI [1,4])
Blood glucose monitoring Continuous Absent
Item
no current use of cgm
boolean
C1820407 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Adhesives Medical
Item
subject has known allergy to medical grade adhesives
boolean
C0020517 (UMLS CUI [1,1])
C0001516 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
Medical condition compromises Patient safety
Item
subject has a medical condition, which in the investigator's opinion, may compromise patient safety
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
Study Subject Participation Status | Glucose monitoring device Affecting Glucose measurement | Glucose monitoring device Affecting Blood glucose management | Investigational New Drugs Affecting Glucose measurement | Investigational New Drugs Affecting Blood glucose management
Item
subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
boolean
C2348568 (UMLS CUI [1])
C0202048 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0337438 (UMLS CUI [2,3])
C0202048 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1638311 (UMLS CUI [3,3])
C0013230 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0337438 (UMLS CUI [4,3])
C0013230 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1638311 (UMLS CUI [5,3])
Blood glucose monitoring Continuous | Medical Device Other | Blood glucose monitoring Continuous Real Time
Item
subject is currently using another cgm device or has used real-time continuous glucose monitoring in the previous 4 weeks
boolean
C1820407 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0025080 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1820407 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
C1550177 (UMLS CUI [3,3])
Peritoneal dialysis solution Containing Icodextrin
Item
subject is receiving peritoneal dialysis solutions containing icodextrin
boolean
C0353714 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0538727 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
female subject who is pregnant or planning to become pregnant within the planned study duration
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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