Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin
Item
treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for at least 12 months
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0393124 (UMLS CUI [2])
Insulin Basal Dose Daily
Item
current daily basal insulin requirement above or equal to 0.3 (i)u/kg/day
boolean
C0021641 (UMLS CUI [1,1])
C0205112 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin a1c (hba1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)
boolean
C0474680 (UMLS CUI [1])
Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount
Item
subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0005794 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Operative Surgical Procedures Blood Loss Amount | Trauma Blood Loss Amount
Item
surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to screening
boolean
C0543467 (UMLS CUI [1,1])
C3163616 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3714660 (UMLS CUI [2,1])
C3163616 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Tobacco use Number of cigarettes per day
Item
smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Refrain from Smoking Unable | Refrain from Smoking Unwilling | Nicotine Gum Unable to discontinue | Nicotine Transdermal Patch Unable to discontinue | Nicotine Gum Discontinue Unwilling | Nicotine Transdermal Patch Discontinue Unwilling
Item
not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period (only clamp period)
boolean
C4086797 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0599654 (UMLS CUI [3,1])
C1548265 (UMLS CUI [3,2])
C0358855 (UMLS CUI [4,1])
C1548265 (UMLS CUI [4,2])
C0599654 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
C0358855 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])