ID

19381

Description

Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose; ODM derived from: https://clinicaltrials.gov/show/NCT00145353

Lien

https://clinicaltrials.gov/show/NCT00145353

Mots-clés

Versions (1)
  1. 27/12/2016 27/12/2016 -
Téléchargé le

27 décembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT00145353

Anglais

Eligibility Type 1 Diabetes Mellitus NCT00145353

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening.
Description

insulin treatment Insulin-Dependent Diabetes Mellitus | Basal insulin Bolus Dosing Unit Daily Frequency

Type de données

boolean

Alias
UMLS CUI [1,1]
C0745343
UMLS CUI [1,2]
C0011854
UMLS CUI [2,1]
C0650607
UMLS CUI [2,2]
C1705509
UMLS CUI [2,3]
C0332173
UMLS CUI [2,4]
C0376249
age: 18-60 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
bmi: 18-27.5
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
no nefro- or neuropathy; i.e. s-creatinin below 120 μmol/l and normal monofilament examination
Description

Kidney Diseases | Neuropathy | Creatinine measurement, serum | Monofilament pressure perception test Normal

Type de données

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0442874
UMLS CUI [3]
C0201976
UMLS CUI [4,1]
C1609492
UMLS CUI [4,2]
C0205307
written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women or patients planning to become pregnant during the investigation period
Description

Pregnancy | Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
reduced eyesight; i.e. visus > 0.3 evaluated at the latest eye exam.
Description

Deteriorating vision | Visual Acuity Ophthalmic examination and evaluation

Type de données

boolean

Alias
UMLS CUI [1]
C0558171
UMLS CUI [2,1]
C0042812
UMLS CUI [2,2]
C0200149
patient lacking the ability to sens insulin sensitivity
Description

Insulin Sensitivity Ability Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0920563
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0332268
serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.
Description

Comorbidity Serious | Heart Diseases | Hepatic Insufficiency Severe | lung; insufficiency Severe | Mental disorders Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018799
UMLS CUI [3,1]
C1306571
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C1401064
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205082
suspicion of abuse or non-compliance
Description

Substance Use Disorders Suspicion | Compliance behavior Limited Suspicion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0242114
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0242114
participation in another clinical trial
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT00145353

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
insulin treatment Insulin-Dependent Diabetes Mellitus | Basal insulin Bolus Dosing Unit Daily Frequency
Item
type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening.
boolean
C0745343 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2,1])
C1705509 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0376249 (UMLS CUI [2,4])
Age
Item
age: 18-60 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi: 18-27.5
boolean
C1305855 (UMLS CUI [1])
Kidney Diseases | Neuropathy | Creatinine measurement, serum | Monofilament pressure perception test Normal
Item
no nefro- or neuropathy; i.e. s-creatinin below 120 μmol/l and normal monofilament examination
boolean
C0022658 (UMLS CUI [1])
C0442874 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1609492 (UMLS CUI [4,1])
C0205307 (UMLS CUI [4,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned
Item
pregnant women or patients planning to become pregnant during the investigation period
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Deteriorating vision | Visual Acuity Ophthalmic examination and evaluation
Item
reduced eyesight; i.e. visus > 0.3 evaluated at the latest eye exam.
boolean
C0558171 (UMLS CUI [1])
C0042812 (UMLS CUI [2,1])
C0200149 (UMLS CUI [2,2])
Insulin Sensitivity Ability Lacking
Item
patient lacking the ability to sens insulin sensitivity
boolean
C0920563 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Comorbidity Serious | Heart Diseases | Hepatic Insufficiency Severe | lung; insufficiency Severe | Mental disorders Severe
Item
serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
C1306571 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1401064 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Substance Use Disorders Suspicion | Compliance behavior Limited Suspicion
Item
suspicion of abuse or non-compliance
boolean
C0038586 (UMLS CUI [1,1])
C0242114 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0242114 (UMLS CUI [2,3])
Study Subject Participation Status
Item
participation in another clinical trial
boolean
C2348568 (UMLS CUI [1])
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