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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

NCT00894270 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2009-05-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Paul L Hofman, MD · Liggins Institute, University of Auckland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • New Zealand

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894270 on ClinicalTrials.gov