ID

15990

Beschrijving

Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia; ODM derived from: https://clinicaltrials.gov/show/NCT02192450

Link

https://clinicaltrials.gov/show/NCT02192450

Trefwoorden

Versies (1)
  1. 24-06-16 24-06-16 -
Geüploaded op

24 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT02192450

Engels

Eligibility Type 1 Diabetes Mellitus NCT02192450

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes > 5 years
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
one or more episodes of nocturnal severe hypoglycaemia during the preceding two years
Beschrijving

Episode of Nocturnal hypoglycemia Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0342315
UMLS CUI [1,3]
C0205082
treated with multiple dose insulin injection (>2) or insulin pump. both human insulin and insulin analogues are allowed
Beschrijving

Administration of insulin Dose multiple | Insulin pump | Insulin, Human | Insulin Analog

Datatype

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439064
UMLS CUI [2]
C1140609
UMLS CUI [3]
C0795635
UMLS CUI [4]
C2825028
willingness to a once daily (od) regimen concerning insulin degludec and insulin glargine
Beschrijving

Treatment regimen insulin degludec human insulin glargine Once daily Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C3491971
UMLS CUI [1,3]
C2047217
UMLS CUI [1,4]
C0556983
UMLS CUI [1,5]
C0600109
willingness to do self-monitoring of blood glucose (smbg) and keep a diary
Beschrijving

Blood Glucose Self-Monitoring Willing | Patient Diary Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0600109
signed informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of primary and secondary adrenal insufficiency, growth hormone deficiency, or untreated myxoedema
Beschrijving

Primary Adrenal Insufficiency | Secondary Adrenal Insufficiency | Somatotropin deficiency | Myxedema untreated

Datatype

boolean

Alias
UMLS CUI [1]
C3887896
UMLS CUI [2]
C0948387
UMLS CUI [3]
C0271561
UMLS CUI [4,1]
C0027145
UMLS CUI [4,2]
C0332155
history of unstable angina or major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last three months)
Beschrijving

Angina, Unstable | Cardiovascular event Major | Myocardial Infarction | Coronary revascularisation | Transient Ischemic Attack | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C1320716
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0877341
UMLS CUI [5]
C0007787
UMLS CUI [6]
C0038454
heart failure, new york heart association (nyha) class iv
Beschrijving

Heart failure | New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1275491
history of malignancy unless a disease-free period exceeding five years
Beschrijving

Malignant Neoplasms | Interval Disease Free of

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1272706
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
history of alcohol or drug abuse
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
treatment with glucose lowering agent(s) other than insulin
Beschrijving

Therapeutic procedure BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3653824
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential who are not using chemical (p-pills or gestagen depots) or mechanical (intra-uterine device) contraception
Beschrijving

Childbearing Potential Contraceptive methods Not used | Chemical contraception | Contraceptives, Oral | Hormonal contraception | Intrauterine Devices

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0445107
UMLS CUI [2]
C1868784
UMLS CUI [3]
C0009905
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0021900
participation in another investigational drug study within the last 3 months
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
inability to understand the informed consent
Beschrijving

Informed Consent Comprehension Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
hba1c > 86 mmol/mol (10%)
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
shifting working hours
Beschrijving

Shift worker

Datatype

boolean

Alias
UMLS CUI [1]
C0425104
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT02192450

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes > 5 years
boolean
C0011854 (UMLS CUI [1])
Episode of Nocturnal hypoglycemia Severe
Item
one or more episodes of nocturnal severe hypoglycaemia during the preceding two years
boolean
C0332189 (UMLS CUI [1,1])
C0342315 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Administration of insulin Dose multiple | Insulin pump | Insulin, Human | Insulin Analog
Item
treated with multiple dose insulin injection (>2) or insulin pump. both human insulin and insulin analogues are allowed
boolean
C0199782 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C1140609 (UMLS CUI [2])
C0795635 (UMLS CUI [3])
C2825028 (UMLS CUI [4])
Treatment regimen insulin degludec human insulin glargine Once daily Willing
Item
willingness to a once daily (od) regimen concerning insulin degludec and insulin glargine
boolean
C0040808 (UMLS CUI [1,1])
C3491971 (UMLS CUI [1,2])
C2047217 (UMLS CUI [1,3])
C0556983 (UMLS CUI [1,4])
C0600109 (UMLS CUI [1,5])
Blood Glucose Self-Monitoring Willing | Patient Diary Willing
Item
willingness to do self-monitoring of blood glucose (smbg) and keep a diary
boolean
C0005803 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3890583 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Primary Adrenal Insufficiency | Secondary Adrenal Insufficiency | Somatotropin deficiency | Myxedema untreated
Item
history of primary and secondary adrenal insufficiency, growth hormone deficiency, or untreated myxoedema
boolean
C3887896 (UMLS CUI [1])
C0948387 (UMLS CUI [2])
C0271561 (UMLS CUI [3])
C0027145 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
Angina, Unstable | Cardiovascular event Major | Myocardial Infarction | Coronary revascularisation | Transient Ischemic Attack | Cerebrovascular accident
Item
history of unstable angina or major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last three months)
boolean
C0002965 (UMLS CUI [1])
C1320716 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0877341 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
Heart failure | New York Heart Association Classification
Item
heart failure, new york heart association (nyha) class iv
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Malignant Neoplasms | Interval Disease Free of
Item
history of malignancy unless a disease-free period exceeding five years
boolean
C0006826 (UMLS CUI [1])
C1272706 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
Substance Use Disorders
Item
history of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Therapeutic procedure BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Item
treatment with glucose lowering agent(s) other than insulin
boolean
C0087111 (UMLS CUI [1,1])
C3653824 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Not used | Chemical contraception | Contraceptives, Oral | Hormonal contraception | Intrauterine Devices
Item
women of childbearing potential who are not using chemical (p-pills or gestagen depots) or mechanical (intra-uterine device) contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0445107 (UMLS CUI [1,3])
C1868784 (UMLS CUI [2])
C0009905 (UMLS CUI [3])
C2985296 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
Study Subject Participation Status
Item
participation in another investigational drug study within the last 3 months
boolean
C2348568 (UMLS CUI [1])
Informed Consent Comprehension Unable
Item
inability to understand the informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Glycosylated hemoglobin A
Item
hba1c > 86 mmol/mol (10%)
boolean
C0019018 (UMLS CUI [1])
Shift worker
Item
shifting working hours
boolean
C0425104 (UMLS CUI [1])
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