ID

28977

Beschrijving

Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00659165

Link

https://clinicaltrials.gov/show/NCT00659165

Trefwoorden

Versies (2)
  1. 18-02-18 18-02-18 -
  2. 18-02-18 18-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 februari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00659165

Engels

Eligibility Diabetes Mellitus NCT00659165

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
treated with long-acting and meal time insulin therapy for at least 2 years
Beschrijving

Insulin, Long-Acting | Insulin regime Meal time

Datatype

boolean

Alias
UMLS CUI [1]
C0304870
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0587119
ages 18 to 60 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
glycosylated hemoglobin value between 7 - 9 mg/dl
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
c-peptide value less than 1.0 pmol/ml 90 minutes after oral boost plus administration.
Beschrijving

C-peptide measurement | Status post Boost Oral

Datatype

boolean

Alias
UMLS CUI [1]
C0202100
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1874596
UMLS CUI [2,3]
C1527415
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
advanced complications of diabetes (nephropathy, retinopathy, significant neuropathy, coronary artery disease)
Beschrijving

Complications of Diabetes Mellitus Advanced | Kidney Diseases | Retinal Diseases | Neuropathy | Coronary Artery Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0035309
UMLS CUI [4]
C0442874
UMLS CUI [5]
C1956346
severe medical illness or medical conditions including congestive heart failure, angina, liver failure or renal failure
Beschrijving

Illness Severe | Medical condition Severe | Congestive heart failure | Angina Pectoris | Liver Failure | Kidney Failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0085605
UMLS CUI [6]
C0035078
pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
alcohol or drug abuse or dependence within three months of study entry
Beschrijving

Substance Use Disorders | Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
less than 50 % agreement on 50-item food questionnaire with the food array "buffet style" study meal.
Beschrijving

Food Frequency Questionnaire | Study Meal Agreement Percentage

Datatype

boolean

Alias
UMLS CUI [1]
C2986698
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C1998602
UMLS CUI [2,3]
C0680240
UMLS CUI [2,4]
C0439165
women of child-bearing age not adhering to the following contraceptive methods: oral contraceptives, barrier methods including condoms or diaphragm, or abstinence.
Beschrijving

Childbearing Potential Contraceptive methods Lacking | Contraceptives, Oral | Contraception, Barrier | Female Condoms | Vaginal contraceptive diaphragm | Sexual Abstinence

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
UMLS CUI [2]
C0009905
UMLS CUI [3]
C0004764
UMLS CUI [4]
C0221829
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0036899
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Similar models

Eligibility Diabetes Mellitus NCT00659165

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Insulin, Long-Acting | Insulin regime Meal time
Item
treated with long-acting and meal time insulin therapy for at least 2 years
boolean
C0304870 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C0587119 (UMLS CUI [2,2])
Age
Item
ages 18 to 60 years of age
boolean
C0001779 (UMLS CUI [1])
Glucohemoglobin measurement
Item
glycosylated hemoglobin value between 7 - 9 mg/dl
boolean
C0202054 (UMLS CUI [1])
C-peptide measurement | Status post Boost Oral
Item
c-peptide value less than 1.0 pmol/ml 90 minutes after oral boost plus administration.
boolean
C0202100 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1874596 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Complications of Diabetes Mellitus Advanced | Kidney Diseases | Retinal Diseases | Neuropathy | Coronary Artery Disease
Item
advanced complications of diabetes (nephropathy, retinopathy, significant neuropathy, coronary artery disease)
boolean
C0342257 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0035309 (UMLS CUI [3])
C0442874 (UMLS CUI [4])
C1956346 (UMLS CUI [5])
Illness Severe | Medical condition Severe | Congestive heart failure | Angina Pectoris | Liver Failure | Kidney Failure
Item
severe medical illness or medical conditions including congestive heart failure, angina, liver failure or renal failure
boolean
C0221423 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0085605 (UMLS CUI [5])
C0035078 (UMLS CUI [6])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence
Item
alcohol or drug abuse or dependence within three months of study entry
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Food Frequency Questionnaire | Study Meal Agreement Percentage
Item
less than 50 % agreement on 50-item food questionnaire with the food array "buffet style" study meal.
boolean
C2986698 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
C0680240 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
Childbearing Potential Contraceptive methods Lacking | Contraceptives, Oral | Contraception, Barrier | Female Condoms | Vaginal contraceptive diaphragm | Sexual Abstinence
Item
women of child-bearing age not adhering to the following contraceptive methods: oral contraceptives, barrier methods including condoms or diaphragm, or abstinence.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0009905 (UMLS CUI [2])
C0004764 (UMLS CUI [3])
C0221829 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
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