ID

33661

Description

Performance Evaluation of Blood Glucose Monitoring Systems; ODM derived from: https://clinicaltrials.gov/show/NCT01504620

Link

https://clinicaltrials.gov/show/NCT01504620

Keywords

  1. 12/18/18 12/18/18 -
  2. 12/18/18 12/18/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 18, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus NCT01504620

Eligibility Diabetes Mellitus NCT01504620

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy subjects or patients with type 1 or type 2 diabetes
Description

Healthy Volunteers | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0011860
screening glucose levels fall into required glucose ranges
Description

Glucose level Within Range Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0337438
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C1514721
UMLS CUI [1,4]
C1514873
screening hematocrit values between 36 % to 55 %
Description

Hematocrit level

Data type

boolean

Alias
UMLS CUI [1]
C0518014
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of hypotension during blood draws
Description

Hypotension During Blood draw

Data type

boolean

Alias
UMLS CUI [1,1]
C0020649
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0005834
intake of drugs known to interfere with blood glucose readings
Description

Pharmaceutical Preparations Interfere with Blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0392201
biochemical safety parameters outside of reference ranges
Description

Safety Parameter Biochemical Irregular

Data type

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C0549193
UMLS CUI [1,3]
C0205474
UMLS CUI [1,4]
C0205271
hb < 11 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
lack of compliance
Description

Compliance behavior Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
history of frequent hypoglycemia
Description

Hypoglycemia Frequent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0332183

Similar models

Eligibility Diabetes Mellitus NCT01504620

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
healthy subjects or patients with type 1 or type 2 diabetes
boolean
C1708335 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Glucose level Within Range Required
Item
screening glucose levels fall into required glucose ranges
boolean
C0337438 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C1514721 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
Hematocrit level
Item
screening hematocrit values between 36 % to 55 %
boolean
C0518014 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypotension During Blood draw
Item
history of hypotension during blood draws
boolean
C0020649 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Pharmaceutical Preparations Interfere with Blood glucose measurement
Item
intake of drugs known to interfere with blood glucose readings
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0392201 (UMLS CUI [1,3])
Safety Parameter Biochemical Irregular
Item
biochemical safety parameters outside of reference ranges
boolean
C0036043 (UMLS CUI [1,1])
C0549193 (UMLS CUI [1,2])
C0205474 (UMLS CUI [1,3])
C0205271 (UMLS CUI [1,4])
Hemoglobin measurement
Item
hb < 11 g/dl
boolean
C0518015 (UMLS CUI [1])
Compliance behavior Lacking
Item
lack of compliance
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Hypoglycemia Frequent
Item
history of frequent hypoglycemia
boolean
C0020615 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])

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