Patient Experiences With Injection Needles

NCT02531776 | Completed

• 1 other identifier: H-6-2014-042
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Needle; Pen needle

Outcome Measures

Primary Outcomes (2)

• Pain on 0-100 mm VAS

  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".

  Immediately after needle insertion.

• Area under curve (AUC) of skin blood perfusion increase

  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.

  Change from baseline (before insertion) to after insertion with continuous measurements for 15 minutes.

Secondary Outcomes (2)

• Needle peak penetration force [N] through human skin

  At time of needle insertion

• Skin reactions (bleeding, bruising, redness, swelling) on a scale from 0 to 4.

  0.5-1 hour after insertion and 20-24 hours after insertion

Study Arms (1)

Subcutaneous insertions of needles

EXPERIMENTAL

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

Interventions

Subcutaneous insertions of needles DEVICE

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.

Subcutaneous insertions of needles

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Publications (15)

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  PMID: 1493028 BACKGROUND

• Smith WC, Lee AJ, Crombie IK, Tunstall-Pedoe H. Control of blood pressure in Scotland: the rule of halves. BMJ. 1990 Apr 14;300(6730):981-3. doi: 10.1136/bmj.300.6730.981.

  PMID: 2344507 BACKGROUND

• Weinger K, Beverly EA. Barriers to achieving glycemic targets: who omits insulin and why? Diabetes Care. 2010 Feb;33(2):450-2. doi: 10.2337/dc09-2132. No abstract available.

  PMID: 20103561 BACKGROUND

• Hirsch L, Gibney M, Berube J, Manocchio J. Impact of a modified needle tip geometry on penetration force as well as acceptability, preference, and perceived pain in subjects with diabetes. J Diabetes Sci Technol. 2012 Mar 1;6(2):328-35. doi: 10.1177/193229681200600216.

  PMID: 22538142 BACKGROUND

• Hirsch LJ, Gibney MA, Albanese J, Qu S, Kassler-Taub K, Klaff LJ, Bailey TS. Comparative glycemic control, safety and patient ratings for a new 4 mm x 32G insulin pen needle in adults with diabetes. Curr Med Res Opin. 2010 Jun;26(6):1531-41. doi: 10.1185/03007995.2010.482499.

  PMID: 20429832 BACKGROUND

• Jaber A, Bozzato GB, Vedrine L, Prais WA, Berube J, Laurent PE. A novel needle for subcutaneous injection of interferon beta-1a: effect on pain in volunteers and satisfaction in patients with multiple sclerosis. BMC Neurol. 2008 Oct 10;8:38. doi: 10.1186/1471-2377-8-38.

  PMID: 18845005 BACKGROUND

• Iwanaga M, Kamoi K. Patient perceptions of injection pain and anxiety: a comparison of NovoFine 32-gauge tip 6mm and Micro Fine Plus 31-gauge 5mm needles. Diabetes Technol Ther. 2009 Feb;11(2):81-6. doi: 10.1089/dia.2008.0027.

  PMID: 19848573 BACKGROUND

• Arendt-Nielsen L, Egekvist H, Bjerring P. Pain following controlled cutaneous insertion of needles with different diameters. Somatosens Mot Res. 2006 Mar-Jun;23(1-2):37-43. doi: 10.1080/08990220600700925.

  PMID: 16846958 BACKGROUND

• Egekvist H, Bjerring P, Arendt-Nielsen L. Pain and mechanical injury of human skin following needle insertions. Eur J Pain. 1999 Mar;3(1):41-49. doi: 10.1053/eujp.1998.0099.

  PMID: 10700336 BACKGROUND

• Schwartz S, Hassman D, Shelmet J, Sievers R, Weinstein R, Liang J, Lyness W. A multicenter, open-label, randomized, two-period crossover trial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge x 6 mm needle versus a 29 gauge x 12.7 mm needle in obese patients with diabetes mellitus. Clin Ther. 2004 Oct;26(10):1663-78. doi: 10.1016/j.clinthera.2004.10.007.

  PMID: 15598483 BACKGROUND

• Kreugel G, Keers JC, Kerstens MN, Wolffenbuttel BH. Randomized trial on the influence of the length of two insulin pen needles on glycemic control and patient preference in obese patients with diabetes. Diabetes Technol Ther. 2011 Jul;13(7):737-41. doi: 10.1089/dia.2011.0010. Epub 2011 Apr 10.

  PMID: 21476936 BACKGROUND

• Praestmark KA, Jensen CB, Stallknecht B, Madsen NB, Kildegaard J. Skin blood perfusion and cellular response to insertion of insulin pen needles with different diameters. J Diabetes Sci Technol. 2014 Jul;8(4):752-9. doi: 10.1177/1932296814531099. Epub 2014 Apr 17.

  PMID: 24876418 BACKGROUND

• Williams G, Pickup J, Clark A, Bowcock S, Cooke E, Keen H. Changes in blood flow close to subcutaneous insulin injection sites in stable and brittle diabetics. Diabetes. 1983 May;32(5):466-73. doi: 10.2337/diab.32.5.466.

  PMID: 6341130 BACKGROUND

• Rayman G, Williams SA, Spencer PD, Smaje LH, Wise PH, Tooke JE. Impaired microvascular hyperaemic response to minor skin trauma in type I diabetes. Br Med J (Clin Res Ed). 1986 May 17;292(6531):1295-8. doi: 10.1136/bmj.292.6531.1295.

  PMID: 2939920 BACKGROUND

• Praestmark KA, Jensen ML, Madsen NB, Kildegaard J, Stallknecht BM. Pen needle design influences ease of insertion, pain, and skin trauma in subjects with type 2 diabetes. BMJ Open Diabetes Res Care. 2016 Dec 15;4(1):e000266. doi: 10.1136/bmjdrc-2016-000266. eCollection 2016.

  PMID: 28074137 DERIVED

Related Links

• Smith EJC, Smith PDC, Thomson GA: Can Hypodermic Needle Injections Be Successfully Simulated and Analyzed in the Laboratory? Journal of Medical Devices 2011, 5: 027513.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kezia A Præstmark, M.Sc.

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: August 24, 2015
• Study Start: December 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

DK (1)