The Influence of the Needle Length on Long Term Glycaemic Control in Insulin Using Obese Diabetic Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale)
研究概览
简要总结
For the administration of insulin, different needles are available with a length from 5 to 12.7mm. Insulin injections with a needle of 8 mm is injected in a lifted skinfold, a 5 mm needle can by used without lifting a skinfold (1). In the Netherlands obese people (BMI ≥ 30) are usually advised to use an 8mm or even longer needle (1). Increased BMI and the thickness of the subcutaneous tissue slow insulin absorption (2, 3, 4), possibly related to reduced subcutaneous blood flow. Furthermore, the capillaries are located just under the skin and between the fat and muscle layer. This could possibly determine the absorbing speed (2). It is not know if the administration of insulin with a 5mm needle by obese people has a different influence on the HbA1c compared to longer needles. The hypothesis of this study is that for the purpose of insulin injections, a 5 mm needle can be used without negative effects on metabolic parameters in patients with Diabetes Mellitus (DM) and a Body Mass Index (BMI) ≥ 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adult patients diagnosed with type 1 and type 2 diabetes mellitus, treated with insulin injections for at least one year and:
- •using an insulin pen
- •a BMI > 30 kg/m2
- •a skinfold thickness of >10 mm at the injection sites
- •stable glycaemic control, with HbA1c between 6 and 10%
- •capable of reading the written information
- •prepared to, and capable of signing an informed consent
排除标准
- •Patients who:
- •change their own insulin dosage and are not prepared to keep a record of these changes
- •have hypoglycaemia unawareness
- •are pregnant or wish to become pregnant
- •have a BMI < 30 kg/m2
- •have a skinfold thickness <10mm
- •have skin problems including lipodystrophy
结局指标
主要结局
Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale)
时间窗: 4 months
次要结局
- HbA1c levels 1,5 anhydroglucitol and fructosamine levels Insulin dose(4 months)