Comparison of Vehicle Delivery Depth Using the NovoFine® 5 mm Needle With or Without a Skin Fold and Inserted at Either 45 or 90 Degrees

NCT00894270 | Completed Phase 4

• 1 other identifier: Novofine002
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Children and adolescents with type 1 diabetes mellitus are required to inject insulin daily. The injection technique should reliably deposit insulin into subcutaneous fat while minimizing inadvertent delivery into either the skin or the underlying muscle, both of which are associated with suboptimal outcomes. The use of shorter, thinner needles reduces the incidence of intramuscular delivery and is associated with reduced discomfort, but increases the risks of both shallow (intradermal) delivery and of loss of insulin through backflow to the skin surface. In the current study, 240 subjects (children and adults) will receive multiple injections of small volumes of sterile air in the thigh and abdomen using 5 mm Novofine® needles, to simulate insulin injections performed at the two sites using various injection techniques (perpendicular or angled needle, with or without skin fold). Ultrasound visualisation of the injected air will allow determination of the incidence of intradermal or intramuscular delivery using the various delivery methods in the trial. In addition, adult subjects will receive injections of a liquid test medium in order to determine the incidence and extent of backflow. Qualitative data on perceived discomfort and information on body composition will also be collected. This investigation will form the basis for recommendations regarding preferred injection technique where 5 mm needles are used.

Conditions

Diabetes Mellitus

Keywords

Diabetes; Injection; Needle

Outcome Measures

Primary Outcomes (1)

• Assess the safety and effectiveness of 5 mm needles using either thigh or abdomen and either a pinched or unpinched skin fold.

  Assessed at the time of the injection

Secondary Outcomes (2)

• Examine leakage of placebo medium from thigh or abdomen.

  Immediately following the injection

• Examine pain/discomfort of injections using the different techniques and the different injection sites.

  Immediately following the injection

Interventions

Sterile air injection PROCEDURE

Injection of 20 microlitres using Novofine 5mm needle of sterile air into either abdomen or thigh using either a pinched or unpinched skin fold and either a vertical or angled approach.

Placebo injection PROCEDURE

Injection of either 20, 40 or 60 IU of placebo media into either abdomen or thigh using either a vertical or angled Novofine 5 mm needle. Leakage of fluid will be blotted and then weighed to establish fluid loss.

Novofine needle DEVICE

Novofine 5mm needle

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject/parent will give signed Informed Consent before any trial related activities. If the parents sign, it will be secured verbally or in older children in writing that they fully agree to participate.
• Type 1 children aged ≥ 6 and \< 19 years. Puberty will be determined by a trained paediatric endocrinologist using standard Tanner Staging.
• Type 1 and 2 diabetic adults aged \> 19 years and ≤ 85 years.

You may not qualify if:

• Skin disease at abdomen and/or thigh.
• Lipohypertrophy at the site of injection.
• Any musculoskeletal abnormalities.
• Psychiatric disorders.

Sponsors & Collaborators

• Liggins Institute: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Liggins Institute

Auckland, Auckland, 1001, New Zealand

Location

Related Publications (1)

• Hofman PL, Lawton SA, Peart JM, Holt JA, Jefferies CA, Robinson E, Cutfield WS. An angled insertion technique using 6-mm needles markedly reduces the risk of intramuscular injections in children and adolescents. Diabet Med. 2007 Dec;24(12):1400-5. doi: 10.1111/j.1464-5491.2007.02272.x.

  PMID: 18042081 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul L Hofman, MD

  Liggins Institute, University of Auckland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 6, 2009
• Study Start: November 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 8, 2009

Record last verified: 2009-05

Locations

NZ (1)