ID

29031

Beskrivning

A Study for Patients With Diabetes Mellitus (IOPA); ODM derived from: https://clinicaltrials.gov/show/NCT00420095

Länk

https://clinicaltrials.gov/show/NCT00420095

Nyckelord

Versioner (2)
  1. 2018-02-21 2018-02-21 -
  2. 2018-02-21 2018-02-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 februari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00420095

Engelsk

Eligibility Diabetes Mellitus, Type 1 NCT00420095

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically diagnosed type 1or type 2 diabetes for at least 2 months
Beskrivning

Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
aged between 18 and 70 (inclusive)
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study
Beskrivning

Insulin Mix | Insulin Dosage Frequency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1720722
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0439603
have glycosylated hemoglobin (hb1ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at visit 1
Beskrivning

Glycosylated haemoglobin increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0239940
compliance with diet and insulin therapy and performs regular blood glucose monitoring
Beskrivning

Compliance behavior Diet therapy | Compliance behavior Insulin regime | Blood Glucose Self-Monitoring Regular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0012159
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0557978
UMLS CUI [3,1]
C0005803
UMLS CUI [3,2]
C0205272
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have used oral antidiabetic agents within 30 days prior to entry into the study
Beskrivning

Antidiabetics Oral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
receive a total daily dose of insulin >2 units/kilogram
Beskrivning

Insulin U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0456683
have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
Beskrivning

Hypoglycemia Severe Episode Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
have a body mass index >35 kilograms per square meter (kg/m2)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
receive chronic systemic glucocorticoid therapy
Beskrivning

Systemic Glucocorticoids chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C0205191
Tillbaka till toppen

Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00420095

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
clinically diagnosed type 1or type 2 diabetes for at least 2 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Age
Item
aged between 18 and 70 (inclusive)
boolean
C0001779 (UMLS CUI [1])
Insulin Mix | Insulin Dosage Frequency
Item
have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study
boolean
C0021641 (UMLS CUI [1,1])
C1720722 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2,3])
Glycosylated haemoglobin increased
Item
have glycosylated hemoglobin (hb1ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at visit 1
boolean
C0239940 (UMLS CUI [1])
Compliance behavior Diet therapy | Compliance behavior Insulin regime | Blood Glucose Self-Monitoring Regular
Item
compliance with diet and insulin therapy and performs regular blood glucose monitoring
boolean
C1321605 (UMLS CUI [1,1])
C0012159 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
C0005803 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral
Item
have used oral antidiabetic agents within 30 days prior to entry into the study
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Insulin U/day
Item
receive a total daily dose of insulin >2 units/kilogram
boolean
C0021641 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Hypoglycemia Severe Episode Quantity
Item
have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Body mass index
Item
have a body mass index >35 kilograms per square meter (kg/m2)
boolean
C1305855 (UMLS CUI [1])
Systemic Glucocorticoids chronic
Item
receive chronic systemic glucocorticoid therapy
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Tillbaka till toppen 

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