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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Assess the safety and effectiveness of 5 mm needles using either thigh or abdomen and either a pinched or unpinched skin fold.
研究概览
简要总结
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.
详细描述
Rationale:
The injection techniques used with children and adolescents with type 1 diabetes mellitus should reliably deposit insulin into subcutaneous fat while minimizing inadvertent intramuscular (IM) insulin injections. Surprisingly, injection technique varies among centres, tends to be protocol driven and is usually dependent on needle length. The recommended injection procedure for diabetic children in our centre include a lifted or pinched skin fold either on the abdomen, thigh or buttocks with perpendicular injection of 8 mm syringes and angled injection of 12.7 mm syringes. However both 8 and 12.7 mm needles, have been associated with frequent IM injections with rates of 38% and 86% respectively, reported using a perpendicular insertion (1, 2). IM injection of regular, NPH and glargine insulin has been associated with more rapid insulin release, variability in glycaemic control and an increased risk of hypoglycaemia (3-5).
The risk of IM insulin deposition is known to be related to a number of variables including younger age, male sex, lower body mass index (BMI), injection technique (angle of insertion and a lifted or pinched skinfold), and needle length (1, 2, 6-8). Reducing the length of the insulin needle reduces the incidence of IM injections, however the use of 5 mm insulin needles may result in insulin being administered too superficially in the dermal layer (9, 10). The consequence of intradermal insulin deposition is largely unknown, but may lead to increased insulin leakage, increased injection pain, and an increased immune response (10). Little information is known about skin thickness, although it does vary with age, obesity and puberty (personal observations).
Smaller, thinner needles are also associated with reduced pain and discomfort. However they may cause greater insulin loss after the injection. This latter issue may also reflect the injection technique used with anecdotal evidence suggesting angled techniques may reduce insulin loss.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Skin disease at abdomen and/or thigh.
- •Lipohypertrophy at the site of injection.
- •Any musculoskeletal abnormalities.
- •Psychiatric disorders.
结局指标
主要结局
Assess the safety and effectiveness of 5 mm needles using either thigh or abdomen and either a pinched or unpinched skin fold.
时间窗: Assessed at the time of the injection
次要结局
- 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)