Patient Experiences With Injection Needles (NEEDLE)
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|ClinicalTrials.gov Identifier: NCT02531776|
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : August 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Device: Subcutaneous insertions of needles||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Patient Experiences With Injection Needles|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Subcutaneous insertions of needles
36 subcutaneous needle insertions per participant with 18 differently designed needles. 30test participants in total. No fluid will be injected. Pain perception will be rated by the subjects, penetration force and skin blood perfusion will be measured, and any skin reactions will be assessed.
Device: Subcutaneous insertions of needles
Various types of needles with different designs and mechanical properties.
Five marketed needles are included: NovoFine 28G x 12 mm (Novo Nordisk A/S, Denmark), NovoFine 30G x 6 mm (Novo Nordisk A/S, Denmark), NovoFine 32G tip x 6 mm (Novo Nordisk A/S, Denmark), BD Ultra-Fine 32G x 4 mm Pentapoint (Beckton, Dickinson & Company, USA), and Terumo Nanopass 34G x 5 mm (Terumo, Japan).
Ten needles have been exclusively manufactured for this clinical trial by Hart Needles, USA. These needles vary in diameter, number of needle tip grinding, and angles of grindings.
Three needles have been modified from the original (NovoFine 32G x 6 mm) with lack of lubrication or damaged needle tip for simulations of repeated use.
No drugs are injected. Only the needle insertion is evaluated.
- Pain on 0-100 mm VAS [ Time Frame: Immediately after needle insertion. ]Pain from the needle insertions will be assessed by a 0-100 mm Visual Analog Scale where 0 mm is "no pain" and 100 mm is "worst possible pain".
- Area under curve (AUC) of skin blood perfusion increase [ Time Frame: Change from baseline (before insertion) to after insertion with continuous measurements for 15 minutes. ]Skin blood perfusion will be measured using Laser Speckle Contrast Analysis which measures the skin's perfusion in an arbitrary unit called Perfusion Units (PU). The increase in skin blood perfusion for 15 minutes after needle insertion is measured as AUC.
- Needle peak penetration force [N] through human skin [ Time Frame: At time of needle insertion ]Measured with a handheld force gauge instrument, measuring the entire insertion through the skin. The peak penetration force [N] is used for comparison.
- Skin reactions (bleeding, bruising, redness, swelling) on a scale from 0 to 4. [ Time Frame: 0.5-1 hour after insertion and 20-24 hours after insertion ]The following skin reactions are evaluated and rated on a scale from 0 (no reaction) to 4 (severe reaction); bleeding, bruising, redness, and swelling. For the acute (0.5-1 hour) evaluation, the investigator evaluates the skin reactions. 20-24 hours after the subject's visit, a phone follow-up is conducted where they are asked to rate the same skin reactions for each needle insertion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531776
|University of Copenhagen|
|Copenhagen, Denmark, 2200|
|Principal Investigator:||Kezia A Præstmark, M.Sc.||University of Copenhagen|