ID

15283

Descripción

Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01697657

Link

https://clinicaltrials.gov/show/NCT01697657

Palabras clave

  1. 24/5/16 24/5/16 -
Subido en

24 de mayo de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Diabetes NCT01697657

Eligibility Diabetes NCT01697657

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01697657
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes
Descripción

type 1 diabetes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
fasting c-peptide below lower limit of normal fasting range
Descripción

fasting c-peptide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2208720
duration of type 1 diabetes for at least 12 months
Descripción

duration of diabetes

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0872146
UMLS CUI [1,2]
C0011854
current treatment: basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
Descripción

current treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
hba1c maximum 9.0% (using biorad variant method)
Descripción

hba1c

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
able and willing to perform self-monitoring of blood glucose
Descripción

blood glucose

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202042
basal insulin requirement at least 30% of the total daily insulin dose
Descripción

basal insulin requirement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0650607
bmi (body mass index) maximum 35 kg/m^2
Descripción

BMI

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
proliferative retinopathy or maculopathy requiring acute treatment
Descripción

retinopathy or maculopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035309
UMLS CUI [2]
C0730362
total daily insulin dose above 1.4 iu/kg/day
Descripción

insulin dose

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021641
known unawareness of hypoglycaemia
Descripción

unawareness of hypoglycaemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342317
impaired hepatic function
Descripción

impaired hepatic function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
impaired renal function
Descripción

impaired renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
cardiac problems
Descripción

cardiac problems

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262402
uncontrolled, treated/untreated hypertension
Descripción

hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
known or suspected allergy to trial product or related products
Descripción

allergy to trial product

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006

Similar models

Eligibility Diabetes NCT01697657

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01697657
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
type 1 diabetes
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
fasting c-peptide
Item
fasting c-peptide below lower limit of normal fasting range
boolean
C2208720 (UMLS CUI [1])
duration of diabetes
Item
duration of type 1 diabetes for at least 12 months
boolean
C0872146 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
current treatment
Item
current treatment: basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
boolean
C0087111 (UMLS CUI [1])
hba1c
Item
hba1c maximum 9.0% (using biorad variant method)
boolean
C0019018 (UMLS CUI [1])
blood glucose
Item
able and willing to perform self-monitoring of blood glucose
boolean
C0202042 (UMLS CUI [1])
basal insulin requirement
Item
basal insulin requirement at least 30% of the total daily insulin dose
boolean
C0650607 (UMLS CUI [1])
BMI
Item
bmi (body mass index) maximum 35 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
retinopathy or maculopathy
Item
proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0035309 (UMLS CUI [1])
C0730362 (UMLS CUI [2])
insulin dose
Item
total daily insulin dose above 1.4 iu/kg/day
boolean
C0021641 (UMLS CUI [1])
unawareness of hypoglycaemia
Item
known unawareness of hypoglycaemia
boolean
C0342317 (UMLS CUI [1])
impaired hepatic function
Item
impaired hepatic function
boolean
C0232741 (UMLS CUI [1])
impaired renal function
Item
impaired renal function
boolean
C0232804 (UMLS CUI [1])
cardiac problems
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
hypertension
Item
uncontrolled, treated/untreated hypertension
boolean
C0020538 (UMLS CUI [1])
allergy to trial product
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])

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