ID

38945

Descripción

Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations; ODM derived from: https://clinicaltrials.gov/show/NCT01680328

Link

https://clinicaltrials.gov/show/NCT01680328

Palabras clave

Versiones (1)
  1. 14/11/19 14/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT01680328

Inglés

Eligibility Diabetes NCT01680328

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01680328
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
type 1 or type 2 diabetes
Descripción

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
daily injection(s) with anti-diabetic drug (insulin or glucagon like peptide-1 (glp-1) analogues) via pen-injector or vial/syringe for more than 6 months
Descripción

Antidiabetics Injection Daily | Insulin | GLP-1 Analogue | Injection via Pen Injector | Injection via Vial | Injection via Syringe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0021641
UMLS CUI [3]
C3273809
UMLS CUI [4,1]
C1533685
UMLS CUI [4,2]
C1550513
UMLS CUI [4,3]
C4025916
UMLS CUI [5,1]
C1533685
UMLS CUI [5,2]
C1550513
UMLS CUI [5,3]
C0184301
UMLS CUI [6,1]
C1533685
UMLS CUI [6,2]
C1550513
UMLS CUI [6,3]
C0039142
body mass index (bmi) between 18.5 and 30.0 kg/m^2 (both included)
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
caucasians
Descripción

Caucasians

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043157
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
Descripción

Hypersensitivity Needle | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0027551
UMLS CUI [2]
C3846158
previous participation in this trial. participation is defined as: screened
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
Descripción

Investigational New Drugs Influence Pain Perception

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C3714605
injection of more than 40 units of insulin per injection
Descripción

Injection Insulin Unit Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1533685
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C0869039
UMLS CUI [1,4]
C1265611
continuous subcutaneous insulin infusion use within the last 6 months
Descripción

Continuous subcutaneous infusion of insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0393124
continuous glucose monitoring use within the last 6 months
Descripción

Continuous glucose monitoring

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4523945
intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
Descripción

Administration of analgesic | Exception Aspirin Low Dose

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262176
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2608320
known active or in-active skin disease in the injection area or that may affect pain perception
Descripción

Dermatologic disorder Injection Area | Dermatologic disorder Affecting Pain Perception

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0205146
UMLS CUI [2,1]
C0037274
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C3714605
anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. however, not on the day of the injections)
Descripción

Anticoagulant therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0150457
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Similar models

Eligibility Diabetes NCT01680328

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01680328
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities.
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
type 1 or type 2 diabetes
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Antidiabetics Injection Daily | Insulin | GLP-1 Analogue | Injection via Pen Injector | Injection via Vial | Injection via Syringe
Item
daily injection(s) with anti-diabetic drug (insulin or glucagon like peptide-1 (glp-1) analogues) via pen-injector or vial/syringe for more than 6 months
boolean
C0935929 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2])
C3273809 (UMLS CUI [3])
C1533685 (UMLS CUI [4,1])
C1550513 (UMLS CUI [4,2])
C4025916 (UMLS CUI [4,3])
C1533685 (UMLS CUI [5,1])
C1550513 (UMLS CUI [5,2])
C0184301 (UMLS CUI [5,3])
C1533685 (UMLS CUI [6,1])
C1550513 (UMLS CUI [6,2])
C0039142 (UMLS CUI [6,3])
Body mass index
Item
body mass index (bmi) between 18.5 and 30.0 kg/m^2 (both included)
boolean
C1305855 (UMLS CUI [1])
Caucasians
Item
caucasians
boolean
C0043157 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Needle | Other Coding
Item
known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
boolean
C0020517 (UMLS CUI [1,1])
C0027551 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Study Subject Participation Status
Item
previous participation in this trial. participation is defined as: screened
boolean
C2348568 (UMLS CUI [1])
Investigational New Drugs Influence Pain Perception
Item
receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
boolean
C0013230 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C3714605 (UMLS CUI [1,3])
Injection Insulin Unit Quantity
Item
injection of more than 40 units of insulin per injection
boolean
C1533685 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0869039 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Continuous subcutaneous infusion of insulin
Item
continuous subcutaneous insulin infusion use within the last 6 months
boolean
C0393124 (UMLS CUI [1])
Continuous glucose monitoring
Item
continuous glucose monitoring use within the last 6 months
boolean
C4523945 (UMLS CUI [1])
Administration of analgesic | Exception Aspirin Low Dose
Item
intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
boolean
C0262176 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2608320 (UMLS CUI [2,2])
Dermatologic disorder Injection Area | Dermatologic disorder Affecting Pain Perception
Item
known active or in-active skin disease in the injection area or that may affect pain perception
boolean
C0037274 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0037274 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C3714605 (UMLS CUI [2,3])
Anticoagulant therapy
Item
anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. however, not on the day of the injections)
boolean
C0150457 (UMLS CUI [1])
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