Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 1 or type 2 diabetes.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Insulin injection Self Pen | Insulin injection times per day
Item
currently self-injects insulin with a pen device at least once daily, and doing so for at least two months prior to enrollment.
boolean
C0199782 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0181364 (UMLS CUI [1,3])
C0199782 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
Insulin injection Pen | Insulin injection Dose Quantity Daily
Item
one or more daily insulin doses injected with the pen device must be > 10 units
boolean
C0199782 (UMLS CUI [1,1])
C0181364 (UMLS CUI [1,2])
C0199782 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
Insulin Pen Specified | Dose U/day Quantity | Other Coding
Item
the insulin pen being used by the subject for the daily dose of > 10 units must be one of the three currently marketed pens: sanofi-aventis solostar, lilly kwikpen, or novo nordisk flexpen
boolean
C0181364 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3846158 (UMLS CUI [3])
Pen Needle Length | Pen Needle Gauge
Item
using a pen needle that is either 4, 5, 6, or 8 mm length, and either 31 or 32 gauge.
boolean
C3897969 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C3897969 (UMLS CUI [2,1])
C3640175 (UMLS CUI [2,2])
Use of Pen Needle Study Protocol | Insulin injection Pen
Item
willing to use the assigned study needles for all pen injections (including insulin and any other pen-based medications).
boolean
C1524063 (UMLS CUI [1,1])
C3897969 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0199782 (UMLS CUI [2,1])
C0181364 (UMLS CUI [2,2])
Antidiabetics unchanged | Diet therapy unchanged | Exercise unchanged
Item
willing to keep their diabetes medications, diet, and exercise the same during the study.
boolean
C0935929 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C0012159 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0015259 (UMLS CUI [3,1])
C0442739 (UMLS CUI [3,2])
Able to read English Language | Able to write English Language | Adherence Instructions English Language
Item
able to read, write and follow instructions in english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C1510802 (UMLS CUI [3,1])
C2051542 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
Informed Consent
Item
able and willing to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Use of Syringe Insulin Dose | Use of Vial Insulin Dose
Item
the subject may also be using syringe and vial for some insulin doses, provided that at least one injection per day is done with an insulin pen and pen needle and is > 10 units.
boolean
C1524063 (UMLS CUI [1,1])
C0039142 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1524063 (UMLS CUI [2,1])
C0184301 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
Knowledge Details Clinical Trial | Knowledge Investigational New Drugs
Item
have previous knowledge of the details of this study or investigational products.
boolean
C0376554 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0376554 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Medical contraindication Investigational New Drugs | Condition At risk Patient | Condition Interferes with Interpretation Research results | Ketoacidosis | Loss of hypoglycemic warning
Item
current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the principal investigator or sub-investigator, would place the subject at risk or have the potential to confound interpretation of the study results (e.g., recent history of ketoacidosis, hypoglycemic unawareness, etc.).
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0220982 (UMLS CUI [4])
C0342317 (UMLS CUI [5])
Study Subject Participation Status Interferes with Research results | Study Subject Participation Status Interferes with Protocol Compliance
Item
currently participating in any other clinical investigation that conflicts with this one, or who have participated in a study with the same indication within the prior 30 days that the principal investigator or sub-investigator believes will conflict with outcomes or ability of the subject to complete all activities required in this study.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Use of Pen Needle Specified | Other Coding
Item
currently using either the pic indolor (artsana) insupen sensitive 8 mm x 32g pen needle or the pic indolor (artsana) insupen sensitive 6mm x 32g pen needle.
boolean
C1524063 (UMLS CUI [1,1])
C3897969 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Drug use Intravenous
Item
history of intravenous drug use (self-reported).
boolean
C0242510 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Employee Pen Needle Company | Contractor Pen Needle Company | Consultant Pen Needle Company
Item
employee, contractor or consultant to any company that manufactures pen needles, including bd.
boolean
C0599987 (UMLS CUI [1,1])
C3897969 (UMLS CUI [1,2])
C0683757 (UMLS CUI [1,3])
C1511499 (UMLS CUI [2,1])
C3897969 (UMLS CUI [2,2])
C0683757 (UMLS CUI [2,3])
C0009817 (UMLS CUI [3,1])
C3897969 (UMLS CUI [3,2])
C0683757 (UMLS CUI [3,3])
Pregnancy
Item
pregnant (self-reported).
boolean
C0032961 (UMLS CUI [1])