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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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Liggins Institute
ClinicalTrials.gov Identifier:
NCT00894270
First received: May 5, 2009
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Procedure: Sterile air injection
Procedure: Placebo injection
Device: Novofine needle
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Liggins Institute:

Primary Outcome Measures:
  • Assess the safety and effectiveness of 5 mm needles using either thigh or abdomen and either a pinched or unpinched skin fold. [ Time Frame: Assessed at the time of the injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine leakage of placebo medium from thigh or abdomen. [ Time Frame: Immediately following the injection ] [ Designated as safety issue: No ]
  • Examine pain/discomfort of injections using the different techniques and the different injection sites. [ Time Frame: Immediately following the injection ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Sterile air injection
    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.
    Procedure: Placebo injection
    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.
    Device: Novofine needle
    Novofine 5mm needle
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Type 1 children aged ≥ 6 and < 19 years. Puberty will be determined by a trained paediatric endocrinologist using standard Tanner Staging.
  3. Type 1 and 2 diabetic adults aged > 19 years and ≤ 85 years.

Exclusion Criteria:

  1. Skin disease at abdomen and/or thigh.
  2. Lipohypertrophy at the site of injection.
  3. Any musculoskeletal abnormalities.
  4. Psychiatric disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894270

Locations
New Zealand
Liggins Institute
Auckland, New Zealand, 1001
Sponsors and Collaborators
Liggins Institute
Novo Nordisk A/S
Investigators
Principal Investigator: Paul L Hofman, MD Liggins Institute, University of Auckland
  More Information

Publications:
Responsible Party: Paul Hofman/ Associate Professor, Liggins Institute, University of Auckland
ClinicalTrials.gov Identifier: NCT00894270     History of Changes
Other Study ID Numbers: Novofine002
Study First Received: May 5, 2009
Last Updated: May 7, 2009
Health Authority: New Zealand: Northern X Regional Ethics Committee

Keywords provided by Liggins Institute:
Diabetes
Injection
Needle

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

ClinicalTrials.gov processed this record on November 20, 2014