ID

35718

Beschreibung

Abbott Sensor Based Glucose Monitoring System Paediatric Study; ODM derived from: https://clinicaltrials.gov/show/NCT02388815

Link

https://clinicaltrials.gov/show/NCT02388815

Stichworte

Versionen (1)
  1. 18.03.19 18.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT02388815

Englisch

Eligibility Diabetes Mellitus NCT02388815

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 4 years, ≤17 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
each participant has an identified caregiver of ≥18 years
Beschreibung

Caregiver | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0085537
UMLS CUI [2]
C0001779
type 1 or type 2 diabetes using insulin administered by injections or csii
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Administration of insulin | Continuous subcutaneous infusion of insulin

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0199782
UMLS CUI [4]
C0393124
currently testing blood glucose, on average at least 2 times per day
Beschreibung

Blood glucose measurement times/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392201
UMLS CUI [1,2]
C0439511
in the investigator's opinion, technically capable of using device (participant and/or caregiver).
Beschreibung

Study Subject Using device | Caregiver Using device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1828349
UMLS CUI [2,1]
C0085537
UMLS CUI [2,2]
C1828349
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition
Beschreibung

Comorbidity compromises Patient safety | Cystic Fibrosis | Mental Disorders, Severe | Eating Disorder | Eating Disorder Suspected | Medical condition Long-term Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2]
C0010674
UMLS CUI [3]
C4046029
UMLS CUI [4]
C0013473
UMLS CUI [5,1]
C0013473
UMLS CUI [5,2]
C0750491
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0443252
UMLS CUI [6,3]
C0205318
currently prescribed oral steroid therapy for any acute or chronic condition
Beschreibung

Oral steroid therapy Medical condition | Oral steroid therapy Chronic condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0574135
UMLS CUI [1,2]
C3843040
UMLS CUI [2,1]
C0574135
UMLS CUI [2,2]
C4315615
currently receiving dialysis treatment or planning to receive dialysis during the study
Beschreibung

Dialysis | Dialysis Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C1301732
female participant known to be pregnant
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management
Beschreibung

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

Datentyp

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]
C0013230
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0337438
UMLS CUI [4,1]
C0202048
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1638311
UMLS CUI [5,1]
C0013230
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1638311
currently using a continuous glucose monitoring (cgm) device
Beschreibung

Continuous glucose monitoring Device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4523945
UMLS CUI [1,2]
C0025080
known (or suspected) allergy to medical grade adhesives
Beschreibung

Hypersensitivity MEDICAL ADHESIVE | Hypersensitivity Suspected MEDICAL ADHESIVE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0726995
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0726995
in the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered)
Beschreibung

Study Subject Participation Status Inappropriate | Caregiver Inappropriate Participation Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0085537
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0679823
UMLS CUI [2,4]
C0008976
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Ähnliche Modelle

Eligibility Diabetes Mellitus NCT02388815

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 4 years, ≤17 years
boolean
C0001779 (UMLS CUI [1])
Caregiver | Age
Item
each participant has an identified caregiver of ≥18 years
boolean
C0085537 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Administration of insulin | Continuous subcutaneous infusion of insulin
Item
type 1 or type 2 diabetes using insulin administered by injections or csii
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0199782 (UMLS CUI [3])
C0393124 (UMLS CUI [4])
Blood glucose measurement times/day
Item
currently testing blood glucose, on average at least 2 times per day
boolean
C0392201 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
Study Subject Using device | Caregiver Using device
Item
in the investigator's opinion, technically capable of using device (participant and/or caregiver).
boolean
C0681850 (UMLS CUI [1,1])
C1828349 (UMLS CUI [1,2])
C0085537 (UMLS CUI [2,1])
C1828349 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Comorbidity compromises Patient safety | Cystic Fibrosis | Mental Disorders, Severe | Eating Disorder | Eating Disorder Suspected | Medical condition Long-term Uncontrolled
Item
concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition
boolean
C0009488 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0010674 (UMLS CUI [2])
C4046029 (UMLS CUI [3])
C0013473 (UMLS CUI [4])
C0013473 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C3843040 (UMLS CUI [6,1])
C0443252 (UMLS CUI [6,2])
C0205318 (UMLS CUI [6,3])
Oral steroid therapy Medical condition | Oral steroid therapy Chronic condition
Item
currently prescribed oral steroid therapy for any acute or chronic condition
boolean
C0574135 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0574135 (UMLS CUI [2,1])
C4315615 (UMLS CUI [2,2])
Dialysis | Dialysis Planned
Item
currently receiving dialysis treatment or planning to receive dialysis during the study
boolean
C0011946 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Pregnancy
Item
female participant known to be pregnant
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status | Glucose monitoring device Affecting Glucose measurement | Investigational New Drugs Affecting Glucose measurement | Glucose monitoring device Affecting Blood glucose management | Investigational New Drugs Affecting Blood glucose management
Item
participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management
boolean
C2348568 (UMLS CUI [1])
C0202048 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0337438 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0337438 (UMLS CUI [3,3])
C0202048 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1638311 (UMLS CUI [4,3])
C0013230 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1638311 (UMLS CUI [5,3])
Continuous glucose monitoring Device
Item
currently using a continuous glucose monitoring (cgm) device
boolean
C4523945 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
Hypersensitivity MEDICAL ADHESIVE | Hypersensitivity Suspected MEDICAL ADHESIVE
Item
known (or suspected) allergy to medical grade adhesives
boolean
C0020517 (UMLS CUI [1,1])
C0726995 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0726995 (UMLS CUI [2,3])
Study Subject Participation Status Inappropriate | Caregiver Inappropriate Participation Clinical Trial
Item
in the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered)
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0085537 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
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