ID

38797

Description

Clinical Evaluation of BD NEXT Pen Needle; ODM derived from: https://clinicaltrials.gov/show/NCT01852136

Link

https://clinicaltrials.gov/show/NCT01852136

Keywords

Versions (1)
  1. 11/4/19 11/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 4, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01852136

English

Eligibility Diabetes Mellitus, Type 2 NCT01852136

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 1 or type 2 diabetes.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
currently self-injects insulin with a pen device at least once daily, and doing so for at least two months prior to enrollment.
Description

Insulin injection Self Pen | Insulin injection times per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0036588
UMLS CUI [1,3]
C0181364
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0439511
one or more daily insulin doses injected with the pen device must be > 10 units
Description

Insulin injection Pen | Insulin injection Dose Quantity Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0181364
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0332173
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
Description

Insulin Pen Specified | Dose U/day Quantity | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0181364
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0456683
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C3846158
using a pen needle that is either 4, 5, 6, or 8 mm length, and either 31 or 32 gauge.
Description

Pen Needle Length | Pen Needle Gauge

Data type

boolean

Alias
UMLS CUI [1,1]
C3897969
UMLS CUI [1,2]
C1444754
UMLS CUI [2,1]
C3897969
UMLS CUI [2,2]
C3640175
willing to use the assigned study needles for all pen injections (including insulin and any other pen-based medications).
Description

Use of Pen Needle Study Protocol | Insulin injection Pen

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C3897969
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0181364
willing to keep their diabetes medications, diet, and exercise the same during the study.
Description

Antidiabetics unchanged | Diet therapy unchanged | Exercise unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0442739
UMLS CUI [2,1]
C0012159
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C0015259
UMLS CUI [3,2]
C0442739
able to read, write and follow instructions in english.
Description

Able to read English Language | Able to write English Language | Adherence Instructions English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C1510802
UMLS CUI [3,2]
C2051542
UMLS CUI [3,3]
C0376245
able and willing to provide informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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.
Description

Use of Syringe Insulin Dose | Use of Vial Insulin Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0039142
UMLS CUI [1,3]
C0021641
UMLS CUI [1,4]
C0178602
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0184301
UMLS CUI [2,3]
C0021641
UMLS CUI [2,4]
C0178602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have previous knowledge of the details of this study or investigational products.
Description

Knowledge Details Clinical Trial | Knowledge Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0376554
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0376554
UMLS CUI [2,2]
C0013230
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.).
Description

Medical contraindication Investigational New Drugs | Condition At risk Patient | Condition Interferes with Interpretation Research results | Ketoacidosis | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030705
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4]
C0220982
UMLS CUI [5]
C0342317
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.
Description

Study Subject Participation Status Interferes with Research results | Study Subject Participation Status Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
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.
Description

Use of Pen Needle Specified | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C3897969
UMLS CUI [1,3]
C0205369
UMLS CUI [2]
C3846158
history of intravenous drug use (self-reported).
Description

Drug use Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0242510
UMLS CUI [1,2]
C1522726
employee, contractor or consultant to any company that manufactures pen needles, including bd.
Description

Employee Pen Needle Company | Contractor Pen Needle Company | Consultant Pen Needle Company

Data type

boolean

Alias
UMLS CUI [1,1]
C0599987
UMLS CUI [1,2]
C3897969
UMLS CUI [1,3]
C0683757
UMLS CUI [2,1]
C1511499
UMLS CUI [2,2]
C3897969
UMLS CUI [2,3]
C0683757
UMLS CUI [3,1]
C0009817
UMLS CUI [3,2]
C3897969
UMLS CUI [3,3]
C0683757
pregnant (self-reported).
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01852136

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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