ID

20718

Beschreibung

Effect of the Fat Content of the Bedtime Snack on Overnight Hypoglycemia; ODM derived from: https://clinicaltrials.gov/show/NCT00493935

Link

https://clinicaltrials.gov/show/NCT00493935

Stichworte

Versionen (1)
  1. 13.03.17 13.03.17 -
Hochgeladen am

13. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type I NCT00493935

Englisch

Eligibility Diabetes Mellitus, Type I NCT00493935

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year (the diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not needed.)
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Insulin regime Daily | C-peptide measurement | Antibody measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0332173
UMLS CUI [3]
C0202100
UMLS CUI [4]
C0201278
age 8.0 years to less than 18.0 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
hba1c <10.0% (the dca2000 will be used to assess eligibility.)
Beschreibung

Glycosylated hemoglobin A Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (stable is defined as no change in the overall insulin program, i.e., no change from sc injections to pump or lantus therapy, or lantus therapy to pump.)
Beschreibung

Insulin regime Stable | Insulin regime unchanged | Subcutaneous injection of insulin | Insulin pump | Lantus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0442739
UMLS CUI [3]
C0586328
UMLS CUI [4]
C1140609
UMLS CUI [5]
C0876064
insulin regimen involves either use of an insulin pump or lantus (with short-acting insulin)
Beschreibung

Insulin regime Involvement with Insulin pump | Insulin regime Involvement with Lantus | Insulin regime Involvement with Short-Acting Insulin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1140609
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0876064
UMLS CUI [3,1]
C0557978
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0356365
nph or lente, if part of the insulin regimen, is given only in the morning before breakfast
Beschreibung

NPH Before Breakfast | Lente Before Breakfast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021658
UMLS CUI [1,2]
C1549040
UMLS CUI [2,1]
C0021659
UMLS CUI [2,2]
C1549040
subject is willing to have a bedtime snack each night and routinely has a snack at least 4 out of 7 nights as part of his/her normal diabetes management
Beschreibung

Bedtime Snack Willing | Diabetes mellitus management Containing Snack

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521112
UMLS CUI [1,2]
C0453863
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0948092
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0453863
subject has a home computer with internet access
Beschreibung

Personal Computer Available | Internet Access Available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162419
UMLS CUI [1,2]
C0470187
UMLS CUI [2,1]
C0282111
UMLS CUI [2,2]
C0444454
UMLS CUI [2,3]
C0470187
for females, subject not intending to become pregnant during the next month
Beschreibung

Gender | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0032992
no expectation that subject will be moving out of the area of the clinical center during the next month
Beschreibung

Relocation of home Unexpected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C4055646
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
Beschreibung

Disease Affecting Use of sensors | Disease Affecting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0183210
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0525058
known celiac disease or other medical disorder (including lactose intolerance or food allergies such as peanuts) which would prevent the subject from consuming the bedtime snack
Beschreibung

Celiac Disease | Disease Preventing Bedtime Snack | Lactose Intolerance | Food Allergy | Allergy to peanuts

Datentyp

boolean

Alias
UMLS CUI [1]
C0007570
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0521112
UMLS CUI [2,4]
C0453863
UMLS CUI [3]
C0022951
UMLS CUI [4]
C0016470
UMLS CUI [5]
C0559470
the presence of any of the following diseases:
Beschreibung

Disease Presence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
asthma if treated with systemic or inhaled corticosteroids in the last 6 months
Beschreibung

Asthma Treated with CORTICOSTEROIDS FOR SYSTEMIC USE | Asthma Treated with inhaled steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C3653708
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C2065041
cystic fibrosis
Beschreibung

Cystic Fibrosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0010674
other major illness that in the judgment of the investigator might interfere with the completion of the protocol (adequately treated thyroid disease does not exclude subjects from enrollment)
Beschreibung

Illness Major Interferes with Protocol Compliance | Thyroid Disease Treated Adequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0040128
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
Beschreibung

Glucocorticoids Oral | Glucocorticoids Inhalation | Medical contraindication Participation Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C0205535
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0679823
UMLS CUI [3,3]
C0008976
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type I NCT00493935

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Insulin regime Daily | C-peptide measurement | Antibody measurement
Item
clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year (the diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not needed.)
boolean
C0011854 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0202100 (UMLS CUI [3])
C0201278 (UMLS CUI [4])
Age
Item
age 8.0 years to less than 18.0 years
boolean
C0001779 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
hba1c <10.0% (the dca2000 will be used to assess eligibility.)
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Insulin regime Stable | Insulin regime unchanged | Subcutaneous injection of insulin | Insulin pump | Lantus
Item
stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (stable is defined as no change in the overall insulin program, i.e., no change from sc injections to pump or lantus therapy, or lantus therapy to pump.)
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0586328 (UMLS CUI [3])
C1140609 (UMLS CUI [4])
C0876064 (UMLS CUI [5])
Insulin regime Involvement with Insulin pump | Insulin regime Involvement with Lantus | Insulin regime Involvement with Short-Acting Insulin
Item
insulin regimen involves either use of an insulin pump or lantus (with short-acting insulin)
boolean
C0557978 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1140609 (UMLS CUI [1,3])
C0557978 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0876064 (UMLS CUI [2,3])
C0557978 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0356365 (UMLS CUI [3,3])
NPH Before Breakfast | Lente Before Breakfast
Item
nph or lente, if part of the insulin regimen, is given only in the morning before breakfast
boolean
C0021658 (UMLS CUI [1,1])
C1549040 (UMLS CUI [1,2])
C0021659 (UMLS CUI [2,1])
C1549040 (UMLS CUI [2,2])
Bedtime Snack Willing | Diabetes mellitus management Containing Snack
Item
subject is willing to have a bedtime snack each night and routinely has a snack at least 4 out of 7 nights as part of his/her normal diabetes management
boolean
C0521112 (UMLS CUI [1,1])
C0453863 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0948092 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0453863 (UMLS CUI [2,3])
Personal Computer Available | Internet Access Available
Item
subject has a home computer with internet access
boolean
C0162419 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0282111 (UMLS CUI [2,1])
C0444454 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
Gender | Pregnancy, Planned
Item
for females, subject not intending to become pregnant during the next month
boolean
C0079399 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Relocation of home Unexpected
Item
no expectation that subject will be moving out of the area of the clinical center during the next month
boolean
C2699029 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Disease Affecting Use of sensors | Disease Affecting Protocol Compliance
Item
the presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0183210 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Celiac Disease | Disease Preventing Bedtime Snack | Lactose Intolerance | Food Allergy | Allergy to peanuts
Item
known celiac disease or other medical disorder (including lactose intolerance or food allergies such as peanuts) which would prevent the subject from consuming the bedtime snack
boolean
C0007570 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0521112 (UMLS CUI [2,3])
C0453863 (UMLS CUI [2,4])
C0022951 (UMLS CUI [3])
C0016470 (UMLS CUI [4])
C0559470 (UMLS CUI [5])
Disease Presence
Item
the presence of any of the following diseases:
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Asthma Treated with CORTICOSTEROIDS FOR SYSTEMIC USE | Asthma Treated with inhaled steroids
Item
asthma if treated with systemic or inhaled corticosteroids in the last 6 months
boolean
C0004096 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
C0004096 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C2065041 (UMLS CUI [2,3])
Cystic Fibrosis
Item
cystic fibrosis
boolean
C0010674 (UMLS CUI [1])
Illness Major Interferes with Protocol Compliance | Thyroid Disease Treated Adequate
Item
other major illness that in the judgment of the investigator might interfere with the completion of the protocol (adequately treated thyroid disease does not exclude subjects from enrollment)
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0040128 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
Glucocorticoids Oral | Glucocorticoids Inhalation | Medical contraindication Participation Clinical Trial
Item
current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
boolean
C0017710 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0017710 (UMLS CUI [2,1])
C0205535 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0679823 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
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