ID

39031

Descripción

Testing the Effect of the InsuPad Device in Daily Life Conditions; ODM derived from: https://clinicaltrials.gov/show/NCT01594801

Link

https://clinicaltrials.gov/show/NCT01594801

Palabras clave

Versiones (1)
  1. 22/11/19 22/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetics Mellitus Type 1 NCT01594801

Inglés

Eligibility Diabetics Mellitus Type 1 NCT01594801

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects aged 18 to 75 years (including 18 and 75 years old).
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
type 1 or type 2 diabetes mellitus subjects with daily short-acting prandial insulin intake of > 60 iu/day.
Descripción

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Short-Acting Insulin Mealtime IU/day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0356365
UMLS CUI [3,2]
C0587119
UMLS CUI [3,3]
C0439465
hba1c >=6.0% and =< 8%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
use of short-acting prandial insulin analogues with multiple daily injections. the analog insulin brands to be used will be either insulin lispro (humalog, liprolog) or insulin aspart (novorapid) or insulin glulisin (apidra).
Descripción

Short-Acting Insulin Analogue Mealtime | Injection multiple Daily | Insulin Lispro | Humalog | Insulin Aspart | NovoLog | Insulin Glulisine | Apidra

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0356365
UMLS CUI [1,2]
C0243071
UMLS CUI [1,3]
C0587119
UMLS CUI [2,1]
C1533685
UMLS CUI [2,2]
C0439064
UMLS CUI [2,3]
C0332173
UMLS CUI [3]
C0293359
UMLS CUI [4]
C0528249
UMLS CUI [5]
C1708521
UMLS CUI [6]
C0939412
UMLS CUI [7]
C1313386
UMLS CUI [8]
C1654827
subject agrees to sign consent form before any study-specific tests or procedures are to be performed.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
study subject is willing to perform at least 5 blood glucose measurements per day for at least 3 months, willing to comply with study procedures and to keep a detailed patient log book.
Descripción

Blood glucose measurement times/day | Protocol Compliance | Subject Diary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392201
UMLS CUI [1,2]
C0439511
UMLS CUI [2]
C0525058
UMLS CUI [3]
C3890583
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
Descripción

Fibrosis Excessive | Lipohypertrophy | Eczema Injection site

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0016059
UMLS CUI [1,2]
C0442802
UMLS CUI [2]
C1262113
UMLS CUI [3,1]
C0013595
UMLS CUI [3,2]
C2700396
known gastro- or enteroparesis.
Descripción

Gastroparesis | Enteroparesis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0152020
UMLS CUI [2]
C1328465
unstable chronic disease other than diabetes mellitus (e. g. unstable angina pectoris, renal disease) for the last six months before study start.
Descripción

Chronic disease Unstable | Exception Diabetes Mellitus | Angina, Unstable | Kidney Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011849
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0022658
severe hypoglycaemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
Descripción

Hypoglycaemic episode Severe | Requirement Glucagon Injection | Requirement Glucose Infusion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C4026725
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0017725
UMLS CUI [3,3]
C0574032
hypoglycaemia unawareness (score > 4 in the hypoglycaemia awareness questionnaire)
Descripción

Loss of hypoglycemic warning | Hypoglycemia Awareness Questionnaire Score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0004448
UMLS CUI [2,3]
C0034394
UMLS CUI [2,4]
C0449820
diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
Descripción

Diabetic Ketoacidosis Severe | Hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011880
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0019993
any known life-threatening disease
Descripción

Life threatening illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3846017
pregnant women, lactating women or women who intend to become pregnant during the observation period
Descripción

Pregnancy | Breast Feeding | Pregnancy intended

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
any other condition or compliance issues that might interfere with study participation or results
Descripción

Condition Interferes with Study Subject Participation Status | Compliance problem Interferes with Study Subject Participation Status | Condition Interferes with Research results | Compliance problem Interferes with Research results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0848919
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0848919
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
subjects with heat sensitivity
Descripción

Heat sensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0231274
subjects involved in or planned to participate in other studies
Descripción

Study Subject Participation Status | Clinical Trials | Clinical Trials Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C1301732
subjects who are incapable of contracting or under guardianship
Descripción

Contracting incapable | Patients Guardianship

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332522
UMLS CUI [1,2]
C1550518
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0870627
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Similar models

Eligibility Diabetics Mellitus Type 1 NCT01594801

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subjects aged 18 to 75 years (including 18 and 75 years old).
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Short-Acting Insulin Mealtime IU/day
Item
type 1 or type 2 diabetes mellitus subjects with daily short-acting prandial insulin intake of > 60 iu/day.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0356365 (UMLS CUI [3,1])
C0587119 (UMLS CUI [3,2])
C0439465 (UMLS CUI [3,3])
Hemoglobin A1c measurement
Item
hba1c >=6.0% and =< 8%
boolean
C0474680 (UMLS CUI [1])
Short-Acting Insulin Analogue Mealtime | Injection multiple Daily | Insulin Lispro | Humalog | Insulin Aspart | NovoLog | Insulin Glulisine | Apidra
Item
use of short-acting prandial insulin analogues with multiple daily injections. the analog insulin brands to be used will be either insulin lispro (humalog, liprolog) or insulin aspart (novorapid) or insulin glulisin (apidra).
boolean
C0356365 (UMLS CUI [1,1])
C0243071 (UMLS CUI [1,2])
C0587119 (UMLS CUI [1,3])
C1533685 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0293359 (UMLS CUI [3])
C0528249 (UMLS CUI [4])
C1708521 (UMLS CUI [5])
C0939412 (UMLS CUI [6])
C1313386 (UMLS CUI [7])
C1654827 (UMLS CUI [8])
Informed Consent
Item
subject agrees to sign consent form before any study-specific tests or procedures are to be performed.
boolean
C0021430 (UMLS CUI [1])
Blood glucose measurement times/day | Protocol Compliance | Subject Diary
Item
study subject is willing to perform at least 5 blood glucose measurements per day for at least 3 months, willing to comply with study procedures and to keep a detailed patient log book.
boolean
C0392201 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C3890583 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Fibrosis Excessive | Lipohypertrophy | Eczema Injection site
Item
excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
boolean
C0016059 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C1262113 (UMLS CUI [2])
C0013595 (UMLS CUI [3,1])
C2700396 (UMLS CUI [3,2])
Gastroparesis | Enteroparesis
Item
known gastro- or enteroparesis.
boolean
C0152020 (UMLS CUI [1])
C1328465 (UMLS CUI [2])
Chronic disease Unstable | Exception Diabetes Mellitus | Angina, Unstable | Kidney Disease
Item
unstable chronic disease other than diabetes mellitus (e. g. unstable angina pectoris, renal disease) for the last six months before study start.
boolean
C0008679 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
Hypoglycaemic episode Severe | Requirement Glucagon Injection | Requirement Glucose Infusion
Item
severe hypoglycaemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C4026725 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0017725 (UMLS CUI [3,2])
C0574032 (UMLS CUI [3,3])
Loss of hypoglycemic warning | Hypoglycemia Awareness Questionnaire Score
Item
hypoglycaemia unawareness (score > 4 in the hypoglycaemia awareness questionnaire)
boolean
C0342317 (UMLS CUI [1])
C0020615 (UMLS CUI [2,1])
C0004448 (UMLS CUI [2,2])
C0034394 (UMLS CUI [2,3])
C0449820 (UMLS CUI [2,4])
Diabetic Ketoacidosis Severe | Hospitalization
Item
diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
boolean
C0011880 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2])
Life threatening illness
Item
any known life-threatening disease
boolean
C3846017 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy intended
Item
pregnant women, lactating women or women who intend to become pregnant during the observation period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
Condition Interferes with Study Subject Participation Status | Compliance problem Interferes with Study Subject Participation Status | Condition Interferes with Research results | Compliance problem Interferes with Research results
Item
any other condition or compliance issues that might interfere with study participation or results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0848919 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0848919 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
Heat sensitivity
Item
subjects with heat sensitivity
boolean
C0231274 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trials | Clinical Trials Planned
Item
subjects involved in or planned to participate in other studies
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0008976 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Contracting incapable | Patients Guardianship
Item
subjects who are incapable of contracting or under guardianship
boolean
C0332522 (UMLS CUI [1,1])
C1550518 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0870627 (UMLS CUI [2,2])
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