Age
Item
male and female subjects at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes mellitus type 1 or type 2
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Continuous subcutaneous infusion of insulin
Item
continuous subcutaneous insulin therapy (csii) for at least 3 months
boolean
C0393124 (UMLS CUI [1])
Insulin pump Consistent with Luer Lock Syringes | Accu-Chek Complete Kit | CARTRIDGE,DISETRONIC | CARTRIDGE,ANIMAS | Other Coding
Item
insulin pump compatible with luer lock infusion set (accu-chek, disetronic, animas, deltec cozmo and minimed 506 to 508)
boolean
C1140609 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0728266 (UMLS CUI [1,3])
C0724905 (UMLS CUI [2])
C1874734 (UMLS CUI [3])
C1874733 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
Infusion Site Suitable Cannula | Infusion Site Suitable Tubing | Use of Cannula Length | Use of Tubing Length
Item
sufficient potential infusion sites suitable for the usage of a cannula length of 8 mm and a tubing length of 70 and 80 cm
boolean
C2697750 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0520453 (UMLS CUI [1,3])
C2697750 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0184165 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0520453 (UMLS CUI [3,2])
C1444754 (UMLS CUI [3,3])
C1524063 (UMLS CUI [4,1])
C0184165 (UMLS CUI [4,2])
C1444754 (UMLS CUI [4,3])
Blood glucose measurement times per day
Item
willing to measure blood glucose at least 4 times per day and 1-3 hrs after each new insertion
boolean
C0392201 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
Participation Willing | Protocol Compliance
Item
willing and able to participate and comply with study procedures including the general recommendation of shifting infusion sets (at least every 3 days)
boolean
C0679823 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Loss of hypoglycemic warning
Item
significantly impaired awareness of hypoglycemia
boolean
C0342317 (UMLS CUI [1])
Ketoacidosis | High risk of Ketoacidosis
Item
a history of or high risk of ketoacidosis during csii therapy
boolean
C0220982 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0220982 (UMLS CUI [2,2])
Catheter site abscess Frequent
Item
frequent catheter abscesses in the past year, as per investigator´s discretion
boolean
C3267041 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])
Plaster Incompatibility | Hypersensitivity Plaster | Relationship Use of Catheter
Item
known strong plaster incompatibility and/or allergy (history of catheter use)
boolean
C0460977 (UMLS CUI [1,1])
C0920399 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0460977 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0085590 (UMLS CUI [3,3])
Chronic disease Unstable | Exception Diabetes Mellitus
Item
unstable chronic disease other than diabetes
boolean
C0008679 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Steroid use chronic | Biological Response Modifiers | Chemotherapy
Item
chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
boolean
C0281991 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
Illness Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate
Item
acute illness or abnormality at the time of screening rendering the patient not suitable to participate in the study in the opinion of the investigator
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Analgesics chronic | Condition Interferes with Pain Assessment
Item
chronic use of analgesics and any other condition interfering with the assessment of pain, as per investigator´s discretion
boolean
C0002771 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0030198 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
are either pregnant or breastfeeding or are currently planning a pregnancy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])