Eligibility Diabetes Mellitus, Type I NCT00493935

1 moduli

StudyEvent: Eligibility
1. Eligibility Diabetes Mellitus, Type I NCT00493935

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Diabetes Mellitus, Type I NCT00493935