ID

35720

Beskrivning

FreeStyle Libre Pro Use in Primary & Secondary Care; ODM derived from: https://clinicaltrials.gov/show/NCT02434315

Länk

https://clinicaltrials.gov/show/NCT02434315

Nyckelord

Versioner (1)
  1. 2019-03-18 2019-03-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 mars 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT02434315

Engelsk

Eligibility Diabetes Mellitus NCT02434315

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age at least 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
Beskrivning

Insulin regime Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011860
hba1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
age at least 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
Beskrivning

Insulin regime Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011860
hba1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
participant is currently prescribed animal insulin.
Beskrivning

Animal Insulin prescribed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003062
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C0278329
total daily dose of insulin (tdd) is >1.75 iu/kg at entry to the study.
Beskrivning

Insulin Daily Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2348070
concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition.
Beskrivning

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

Datatyp

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
has a pacemaker or any other neurostimulators.
Beskrivning

Artificial cardiac pacemaker | Neurostimulator

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0582124
currently prescribed oral, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period.
Beskrivning

Oral steroid therapy Medical condition | Oral steroid therapy Chronic condition | Intramuscular steroid therapy Medical condition | Intramuscular steroid therapy Chronic condition | Steroid therapy Intravenous Medical condition | Steroid therapy Intravenous Chronic condition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0574135
UMLS CUI [1,2]
C3843040
UMLS CUI [2,1]
C0574135
UMLS CUI [2,2]
C4315615
UMLS CUI [3,1]
C0585373
UMLS CUI [3,2]
C3843040
UMLS CUI [4,1]
C0585373
UMLS CUI [4,2]
C4315615
UMLS CUI [5,1]
C0149783
UMLS CUI [5,2]
C1522726
UMLS CUI [5,3]
C3843040
UMLS CUI [6,1]
C0149783
UMLS CUI [6,2]
C1522726
UMLS CUI [6,3]
C4315615
currently receiving dialysis treatment or planning to receive dialysis during the study.
Beskrivning

Dialysis | Dialysis Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C1301732
women who are pregnant, plan to become pregnant or become pregnant during the study.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
Beskrivning

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

Datatyp

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 / has previously used a sensor based glucose monitoring system (including retrospective glucose monitoring system) within the last 6 months.
Beskrivning

Glucose monitoring system Sensor Based | Glucose monitoring system Retrospective

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3873850
UMLS CUI [1,2]
C0872382
UMLS CUI [1,3]
C1705938
UMLS CUI [2,1]
C3873850
UMLS CUI [2,2]
C1514923
currently using continuous subcutaneous insulin infusion (csii).
Beskrivning

Continuous subcutaneous infusion of insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0393124
known (or suspected) allergy to medical grade adhesives.
Beskrivning

Hypersensitivity MEDICAL ADHESIVE | Hypersensitivity Suspected MEDICAL ADHESIVE

Datatyp

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 is unsuitable to participate due to any other cause/reason.
Beskrivning

Study Subject Participation Status Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Diabetes Mellitus NCT02434315

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age at least 18 years.
boolean
C0001779 (UMLS CUI [1])
Insulin regime Non-Insulin-Dependent Diabetes Mellitus
Item
type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
boolean
C0557978 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age at least 18 years.
boolean
C0001779 (UMLS CUI [1])
Insulin regime Non-Insulin-Dependent Diabetes Mellitus
Item
type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
boolean
C0557978 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
boolean
C0474680 (UMLS CUI [1])
Animal Insulin prescribed
Item
participant is currently prescribed animal insulin.
boolean
C0003062 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
Insulin Daily Dose
Item
total daily dose of insulin (tdd) is >1.75 iu/kg at entry to the study.
boolean
C0021641 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
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, a diagnosed 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])
Artificial cardiac pacemaker | Neurostimulator
Item
has a pacemaker or any other neurostimulators.
boolean
C0030163 (UMLS CUI [1])
C0582124 (UMLS CUI [2])
Oral steroid therapy Medical condition | Oral steroid therapy Chronic condition | Intramuscular steroid therapy Medical condition | Intramuscular steroid therapy Chronic condition | Steroid therapy Intravenous Medical condition | Steroid therapy Intravenous Chronic condition
Item
currently prescribed oral, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period.
boolean
C0574135 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0574135 (UMLS CUI [2,1])
C4315615 (UMLS CUI [2,2])
C0585373 (UMLS CUI [3,1])
C3843040 (UMLS CUI [3,2])
C0585373 (UMLS CUI [4,1])
C4315615 (UMLS CUI [4,2])
C0149783 (UMLS CUI [5,1])
C1522726 (UMLS CUI [5,2])
C3843040 (UMLS CUI [5,3])
C0149783 (UMLS CUI [6,1])
C1522726 (UMLS CUI [6,2])
C4315615 (UMLS CUI [6,3])
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 | Pregnancy, Planned
Item
women who are pregnant, plan to become pregnant or become pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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])
Glucose monitoring system Sensor Based | Glucose monitoring system Retrospective
Item
currently using / has previously used a sensor based glucose monitoring system (including retrospective glucose monitoring system) within the last 6 months.
boolean
C3873850 (UMLS CUI [1,1])
C0872382 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C3873850 (UMLS CUI [2,1])
C1514923 (UMLS CUI [2,2])
Continuous subcutaneous infusion of insulin
Item
currently using continuous subcutaneous insulin infusion (csii).
boolean
C0393124 (UMLS CUI [1])
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
Item
in the investigator's opinion the participant is unsuitable to participate due to any other cause/reason.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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