ID

33102

Descripción

Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT00906529

Link

https://clinicaltrials.gov/show/NCT00906529

Palabras clave

Versiones (1)
  1. 27/11/18 27/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00906529

Inglés

Eligibility Type 2 Diabetes NCT00906529

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
existing diagnosis of type 2 diabetes.
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
admitted to a non-telemetry, non-icu medicine inpatient bed.
Descripción

Inpatient Bed | Telemetry Absent | Intensive care unit Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021562
UMLS CUI [1,2]
C0004916
UMLS CUI [2,1]
C0039451
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021708
UMLS CUI [3,2]
C0332197
willing and able to give informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
hgba1c of any value will be accepted.
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
admitted to a telemetry, icu, or non-medicine inpatient bed (e.g., surgery, neurosurgery, obstetrics/gynecology, psychiatry).
Descripción

Inpatient Bed | Telemetry | Intensive care unit | Surgery | Neurosurgery | Obstetrics | Gynecology | Psychiatry

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021562
UMLS CUI [1,2]
C0004916
UMLS CUI [2]
C0039451
UMLS CUI [3]
C0021708
UMLS CUI [4]
C0038896
UMLS CUI [5]
C1552762
UMLS CUI [6]
C0028775
UMLS CUI [7]
C0587481
UMLS CUI [8]
C0587494
diabetic ketoacidosis (arterial ph <7.24, serum bicarbonate <15, positive serum ketones, anion gap >12)
Descripción

Diabetic Ketoacidosis | Pulmonary arterial hypertension | Serum bicarbonate measurement | Serum ketones Positive | Anion gap measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C2973725
UMLS CUI [3]
C0428301
UMLS CUI [4,1]
C0036812
UMLS CUI [4,2]
C1514241
UMLS CUI [5]
C0201889
hyperosmolar hyperglycemic state (blood glucose >200 mg/dl, serum osmolarity >320 mosm/kg)
Descripción

Hyperosmolar Hyperglycemic State | Blood glucose measurement | Serum Osmolarity measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3888846
UMLS CUI [2]
C0392201
UMLS CUI [3,1]
C0229671
UMLS CUI [3,2]
C0201804
inability to cooperate with study personnel.
Descripción

Compliance behavior Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1299582
known allergy or intolerance to detemir or novolog.
Descripción

Hypersensitivity Detemir | Intolerance to Detemir | Hypersensitivity NovoLog | Intolerance to NovoLog

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0537270
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0537270
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0939412
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0939412
admission to the hospital >24 hours from entry into the study.
Descripción

Hospital admission

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0184666
admission to the hospital for inpatient hospice care.
Descripción

Hospital admission Full care by hospice

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0421320
admission/continued admission to the hospital for procurement of a guardian.
Descripción

Hospital admission Procurement Guardian

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C1709695
UMLS CUI [1,3]
C1274041
admission/continued admission to the hospital for rehabilitation.
Descripción

Hospital admission Rehabilitation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0034991
patients admitted with the diagnosis of acute coronary syndrome.
Descripción

Acute Coronary Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948089
patients admitted with the diagnosis of acute cerebrovascular accident.
Descripción

Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038454
patients currently pregnant or breast-feeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients not fluent in english or spanish as it will be difficult to obtained written informed consent in another language.
Descripción

Lacking Able to speak fluently English Language | Lacking Able to speak fluently Spanish Language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564241
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0564241
UMLS CUI [2,3]
C0037750
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Similar models

Eligibility Type 2 Diabetes NCT00906529

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
existing diagnosis of type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Inpatient Bed | Telemetry Absent | Intensive care unit Absent
Item
admitted to a non-telemetry, non-icu medicine inpatient bed.
boolean
C0021562 (UMLS CUI [1,1])
C0004916 (UMLS CUI [1,2])
C0039451 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021708 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
willing and able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hgba1c of any value will be accepted.
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Inpatient Bed | Telemetry | Intensive care unit | Surgery | Neurosurgery | Obstetrics | Gynecology | Psychiatry
Item
admitted to a telemetry, icu, or non-medicine inpatient bed (e.g., surgery, neurosurgery, obstetrics/gynecology, psychiatry).
boolean
C0021562 (UMLS CUI [1,1])
C0004916 (UMLS CUI [1,2])
C0039451 (UMLS CUI [2])
C0021708 (UMLS CUI [3])
C0038896 (UMLS CUI [4])
C1552762 (UMLS CUI [5])
C0028775 (UMLS CUI [6])
C0587481 (UMLS CUI [7])
C0587494 (UMLS CUI [8])
Diabetic Ketoacidosis | Pulmonary arterial hypertension | Serum bicarbonate measurement | Serum ketones Positive | Anion gap measurement
Item
diabetic ketoacidosis (arterial ph <7.24, serum bicarbonate <15, positive serum ketones, anion gap >12)
boolean
C0011880 (UMLS CUI [1])
C2973725 (UMLS CUI [2])
C0428301 (UMLS CUI [3])
C0036812 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0201889 (UMLS CUI [5])
Hyperosmolar Hyperglycemic State | Blood glucose measurement | Serum Osmolarity measurement
Item
hyperosmolar hyperglycemic state (blood glucose >200 mg/dl, serum osmolarity >320 mosm/kg)
boolean
C3888846 (UMLS CUI [1])
C0392201 (UMLS CUI [2])
C0229671 (UMLS CUI [3,1])
C0201804 (UMLS CUI [3,2])
Compliance behavior Unable
Item
inability to cooperate with study personnel.
boolean
C1321605 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity Detemir | Intolerance to Detemir | Hypersensitivity NovoLog | Intolerance to NovoLog
Item
known allergy or intolerance to detemir or novolog.
boolean
C0020517 (UMLS CUI [1,1])
C0537270 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0537270 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0939412 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0939412 (UMLS CUI [4,2])
Hospital admission
Item
admission to the hospital >24 hours from entry into the study.
boolean
C0184666 (UMLS CUI [1])
Hospital admission Full care by hospice
Item
admission to the hospital for inpatient hospice care.
boolean
C0184666 (UMLS CUI [1,1])
C0421320 (UMLS CUI [1,2])
Hospital admission Procurement Guardian
Item
admission/continued admission to the hospital for procurement of a guardian.
boolean
C0184666 (UMLS CUI [1,1])
C1709695 (UMLS CUI [1,2])
C1274041 (UMLS CUI [1,3])
Hospital admission Rehabilitation
Item
admission/continued admission to the hospital for rehabilitation.
boolean
C0184666 (UMLS CUI [1,1])
C0034991 (UMLS CUI [1,2])
Acute Coronary Syndrome
Item
patients admitted with the diagnosis of acute coronary syndrome.
boolean
C0948089 (UMLS CUI [1])
Cerebrovascular accident
Item
patients admitted with the diagnosis of acute cerebrovascular accident.
boolean
C0038454 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patients currently pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Lacking Able to speak fluently English Language | Lacking Able to speak fluently Spanish Language
Item
patients not fluent in english or spanish as it will be difficult to obtained written informed consent in another language.
boolean
C0332268 (UMLS CUI [1,1])
C0564241 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0564241 (UMLS CUI [2,2])
C0037750 (UMLS CUI [2,3])
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