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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00894270




Registration number
NCT00894270
Ethics application status
Date submitted
5/05/2009
Date registered
6/05/2009
Date last updated
8/05/2009

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
Novofine002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Sterile air injection
Treatment: Surgery - Placebo injection
Treatment: Devices - Novofine needle

Treatment: Surgery: 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.

Treatment: Surgery: 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.

Treatment: Devices: Novofine needle
Novofine 5mm needle
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess the safety and effectiveness of 5 mm needles using either thigh or abdomen and either a pinched or unpinched skin fold.
Timepoint [1] 0 0
Assessed at the time of the injection
Secondary outcome [1] 0 0
Examine leakage of placebo medium from thigh or abdomen.
Timepoint [1] 0 0
Immediately following the injection
Secondary outcome [2] 0 0
Examine pain/discomfort of injections using the different techniques and the different injection sites.
Timepoint [2] 0 0
Immediately following the injection

Eligibility
Key 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.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Skin disease at abdomen and/or thigh.

2. Lipohypertrophy at the site of injection.

3. Any musculoskeletal abnormalities.

4. Psychiatric disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Liggins Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novo Nordisk A/S
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00894270
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Paul L Hofman, MD
Address 0 0
Liggins Institute, University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00894270