At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Patient Experiences With Injection Needles
In Brief
A clinical study evaluating Subcutaneous insertions of needles for Diabetes Mellitus, Type 2. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This study will focus on how different injection needles are perceived by patients. The needles differ in design and mechanical properties, and will be tested in people with Type 2 Diabetes. The measured parameters during and after needle insertion are: penetration force through skin (measured with force gauge), pain perception (rated on visual analog scale, VAS, on a scale from 0 to 10), and skin blood perfusion at insertion site (measured with laser speckle contrast scanner). Furthermore, any skin reactions will be recorded.
Study Details
Timeline
Interventions
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.