0 Ratings
ID

15990

Description

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

Link

https://clinicaltrials.gov/show/NCT02192450

Keywords

Versions (1)
  1. 6/24/16 6/24/16 -
Uploaded on

June 24, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Type 1 Diabetes Mellitus NCT02192450

    English

    Eligibility Type 1 Diabetes Mellitus NCT02192450

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    type 1 diabetes > 5 years
    Description

    Diabetes Mellitus, Insulin-Dependent

    Data type

    boolean

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

    Episode of Nocturnal hypoglycemia Severe

    Data type

    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
    Description

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

    Data type

    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
    Description

    Treatment regimen insulin degludec human insulin glargine Once daily Willing

    Data type

    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
    Description

    Blood Glucose Self-Monitoring Willing | Patient Diary Willing

    Data type

    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
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

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

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

    Data type

    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)
    Description

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

    Data type

    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
    Description

    Heart failure | New York Heart Association Classification

    Data type

    boolean

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

    Malignant Neoplasms | Interval Disease Free of

    Data type

    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
    Description

    Substance Use Disorders

    Data type

    boolean

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

    Therapeutic procedure BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

    Data type

    boolean

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

    Pregnancy | Breast Feeding

    Data type

    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
    Description

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

    Data type

    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
    Description

    Study Subject Participation Status

    Data type

    boolean

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

    Informed Consent Comprehension Unable

    Data type

    boolean

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

    Glycosylated hemoglobin A

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019018
    shifting working hours
    Description

    Shift worker

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0425104
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    Similar models

    Eligibility Type 1 Diabetes Mellitus NCT02192450

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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