Status:
COMPLETED
Clinical Evaluation of BD NEXT Pen Needle
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Eligibility:
All Genders
35-80 years
Brief Summary
This prospective, multi-center, 2 period cross-over study is designed to determine if people who use injection pens for subcutaneous medication delivery prefer the BD NEXT pen needle (PN) in compariso...
Detailed Description
Using their usual insulin doses, pen and injection routine, subjects will be asked to compare two different pen needles (PNs) of corresponding gauge (GA) and length, one being the investigational (ext...
Eligibility Criteria
Inclusion
- Diagnosed with Type 1 or Type 2 diabetes.
- Currently self-injects insulin with a pen device at least once daily, and doing so for at least two months prior to enrollment.
- One or more daily insulin doses injected with the pen device must be \> 10 units
- 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
- Using a pen needle that is either 4, 5, 6, or 8 mm length, and either 31 or 32 gauge.
- Willing to use the assigned study needles for all pen injections (including insulin and any other pen-based medications).
- Willing to keep their diabetes medications, diet, and exercise the same during the study.
- Able to read, write and follow instructions in English.
- Able and willing to provide informed consent.
- 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.
Exclusion
- Have previous knowledge of the details of this study or investigational products.
- 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.).
- 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.
- 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.
- History of intravenous drug use (self-reported).
- Employee, contractor or consultant to any company that manufactures pen needles, including BD.
- Pregnant (self-reported).
Key Trial Info
Start Date :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT01852136
Start Date
September 1 2012
End Date
December 1 2012
Last Update
February 9 2017
Active Locations (5)
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1
Physicians Research Center
Toms River, New Jersey, United States, 08755
2
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803
3
Holston Medical Group
Kingsport, Tennessee, United States, 37660
4
Corporation Lane Internal Medicine and Research Center
Virginia Beach, Virginia, United States, 23462