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
|ClinicalTrials.gov Identifier: NCT00894270|
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : May 8, 2009
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 or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Procedure: Sterile air injection Procedure: Placebo injection Device: Novofine needle||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
- 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
- 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 ]
- Examine leakage of placebo medium from thigh or abdomen. [ Time Frame: Immediately following the injection ]
- Examine pain/discomfort of injections using the different techniques and the different injection sites. [ Time Frame: Immediately following the injection ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894270
|Auckland, New Zealand, 1001|
|Principal Investigator:||Paul L Hofman, MD||Liggins Institute, University of Auckland|