ID

20590

Beschreibung

Semi-automatic Response System(SARS)in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01058733

Link

https://clinicaltrials.gov/show/NCT01058733

Stichworte

Versionen (1)
  1. 05.03.17 05.03.17 -
Hochgeladen am

5. März 2017

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT01058733

Englisch

Eligibility Diabetes Mellitus NCT01058733

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women aged 20-70 years with type 2 diabetes
Beschreibung

Age | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
lasting more than one year who had used the online communication system for diabetes management at the web site https://www.bi odang.com for more than six months
Beschreibung

Diabetes mellitus management Communication System Web Site

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948092
UMLS CUI [1,2]
C0868936
UMLS CUI [1,3]
C2349146
baseline hba1c level was 6-10%
Beschreibung

Glycosylated hemoglobin A Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
patients who able and willing to complete glucose-monitoring diaries on a web chart as instructed.
Beschreibung

Glucose measurement by monitoring device Web Site Patient Diary Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202048
UMLS CUI [1,2]
C2349146
UMLS CUI [1,3]
C3890583
UMLS CUI [1,4]
C0205197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who required intensive insulin therapy (multiple insulin injections or insulin pump therapy) or who were unwilling to use self-monitoring of blood glucose (smbg)
Beschreibung

Insulin regime Patient need for | Administration of insulin multiple | Insulin pump Therapeutic procedure | Blood Glucose Self-Monitoring Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0439064
UMLS CUI [3,1]
C1140609
UMLS CUI [3,2]
C0087111
UMLS CUI [4,1]
C0005803
UMLS CUI [4,2]
C0558080
acute metabolic complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar non-ketotic hyperglycaemia, lactic acidosis)
Beschreibung

metabolic complications Diabetes Mellitus | Diabetic Ketoacidosis | NON-KETOTIC HYPEROSMOLAR HYPERGLYCEMIA | Acidosis, Lactic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1393263
UMLS CUI [1,2]
C0011849
UMLS CUI [2]
C0011880
UMLS CUI [3]
C0242019
UMLS CUI [4]
C0001125
serum creatinine concentration >2.0 mg/dl at screening
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
active liver disease or alt or ast activities >2.5 times the upper limit of normal
Beschreibung

Liver diseases | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
acute illness, chronic infection, heart failure of nyha class iii or iv
Beschreibung

Illness | Chronic infectious disease | Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0151317
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
recent myocardial infarction or stroke during the past six months
Beschreibung

Myocardial Infarction | Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
pregnancy or gdm, or any other factor likely to limit protocol compliance or reporting of adverse events
Beschreibung

Pregnancy | Gestational Diabetes | Factor Protocol Compliance Limited | Reporting Adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0085207
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0700287
UMLS CUI [4,2]
C0877248
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Ähnliche Modelle

Eligibility Diabetes Mellitus NCT01058733

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent
Item
men or women aged 20-70 years with type 2 diabetes
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Diabetes mellitus management Communication System Web Site
Item
lasting more than one year who had used the online communication system for diabetes management at the web site https://www.bi odang.com for more than six months
boolean
C0948092 (UMLS CUI [1,1])
C0868936 (UMLS CUI [1,2])
C2349146 (UMLS CUI [1,3])
Glycosylated hemoglobin A Percentage
Item
baseline hba1c level was 6-10%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Glucose measurement by monitoring device Web Site Patient Diary Completion
Item
patients who able and willing to complete glucose-monitoring diaries on a web chart as instructed.
boolean
C0202048 (UMLS CUI [1,1])
C2349146 (UMLS CUI [1,2])
C3890583 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Insulin regime Patient need for | Administration of insulin multiple | Insulin pump Therapeutic procedure | Blood Glucose Self-Monitoring Unwilling
Item
patients who required intensive insulin therapy (multiple insulin injections or insulin pump therapy) or who were unwilling to use self-monitoring of blood glucose (smbg)
boolean
C0557978 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0199782 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C1140609 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0005803 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
metabolic complications Diabetes Mellitus | Diabetic Ketoacidosis | NON-KETOTIC HYPEROSMOLAR HYPERGLYCEMIA | Acidosis, Lactic
Item
acute metabolic complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar non-ketotic hyperglycaemia, lactic acidosis)
boolean
C1393263 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0011880 (UMLS CUI [2])
C0242019 (UMLS CUI [3])
C0001125 (UMLS CUI [4])
Creatinine measurement, serum
Item
serum creatinine concentration >2.0 mg/dl at screening
boolean
C0201976 (UMLS CUI [1])
Liver diseases | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
active liver disease or alt or ast activities >2.5 times the upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Illness | Chronic infectious disease | Heart failure New York Heart Association Classification
Item
acute illness, chronic infection, heart failure of nyha class iii or iv
boolean
C0221423 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
Myocardial Infarction | Cerebrovascular accident
Item
recent myocardial infarction or stroke during the past six months
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Pregnancy | Gestational Diabetes | Factor Protocol Compliance Limited | Reporting Adverse event
Item
pregnancy or gdm, or any other factor likely to limit protocol compliance or reporting of adverse events
boolean
C0032961 (UMLS CUI [1])
C0085207 (UMLS CUI [2])
C1521761 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0700287 (UMLS CUI [4,1])
C0877248 (UMLS CUI [4,2])
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