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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
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Bente Merete Stallknecht, University of Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: Subcutaneous insertions of needles Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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".

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participation in the study is possible if you

  • Are a man or woman with type 2 diabetes. An equal distribution of men and women is sought to compare findings between the sexes.
  • Take daily injection(s) of anti-diabetic medicine (insulin or glucagon-like-peptide-1 (GLP-1) analogues) with a pen or syringe, and have done so for more than 6 months.
  • Are 18-70 years (both included)
  • Are slightly overweight, i.e. BMI 25-35 kg/m2.
  • Are inactive for at least 6 hours before the study, i.e. transport to the investigation must be carried out without significant physical activity.
  • Are Caucasian. Inclusion of other ethnicities can increase data variation and a darker skin tone can make it difficult to read any skin reactions.
  • Have no significant body hair on the abdomen (can be shaved away, and if so, this should be done at least 48 hours before the test day)

Exclusion Criteria:

Participation in the study is not possible if one or more of the following criteria are met:

  • Known or suspected hypersensitivity to needles, including the needle's lubricant (typically silicon oil), pen / ink color, or other materials that come into contact with the injection site
  • Previous participation in the trial
  • Intake of medical product which may influence pain perception within the last 14 days before trial
  • Insulin pump user
  • Previous surgery in the abdominal wall
  • Intake of any painkillers within the last week before the test (low-dose aspirin in cardiovascular prophylactic doses is allowed)
  • Known active or inactive skin diseases in the abdominal area that may influence pain perception or blood perfusion
  • Anticoagulant therapy within the last month (low-dose aspirin in cardiovascular prophylactic doses is authorized, except on test day)
  • Pregnant or breastfeeding
  • Consumption of alcohol within the last 24 hours before the test
  • Intake of drugs within the last 48 hours before the experiment
  • Smokers and ex-smokers who use nicotine products (allowed if not used within the past 6 months prior to study entry)
  • Moderate to severe lipodystrophy
  • Severe neuropathy (grade 0/8, 1/8 or 2/8). This is examined with a Rydell-Seiffer tuning fork.

Information from the National Library of Medicine

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


Locations
Denmark
University of Copenhagen
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Novo Nordisk A/S
Investigators
Principal Investigator: Kezia A Præstmark, M.Sc. University of Copenhagen

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bente Merete Stallknecht, Professor, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02531776     History of Changes
Other Study ID Numbers: H-6-2014-042
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Bente Merete Stallknecht, University of Copenhagen:
Diabetes
Needle
Pen needle

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases