Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus Using CGMS
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- the relationship between HbA1C and injection score
研究概览
简要总结
To compare patients and nurses using insulin pen injector to inject premixed insulin respectively, using continuous glucose monitoring system to evaluate the glucose excursion in the two sets, study the relationship between glucose excursion and inject technique in type 2 diabetes mellitus.
详细描述
A total of 60 patients with type 2 diabetes who used premixed insulin will enrolled in this study.Measure their blood pressure，height and weight, BMI, liver and kidney function, blood lipids, glycosylated hemoglobin, fasting glucose, 2 hour postprandial glucose，fasting C peptide, 2 hour postprandial C peptide, fasting glucagon, 2 hour postprandial glucagon,fasting serum insulin，2 hour postprandial serum insulin，urinary albumin and insulin antibodies.The first and second days，the patients inject premixed insulin themselves，the specialist nurse graded the patient's injection technique score.The third and the fourth days the nurse change a new insulin with the same types maintain the same injection dosage.The patient need perform continuous glucose monitoring system(CGMS) for 96-hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •type 2 diabetes patients
- •aged 20-80 years
- •had been on premixed insulin and used an insulin pen for at least 3 months
- •fasting glucose between 6.1-16 mmolL, postprandial(or random) glucose below 22.2mmol/L.
- •No acute complications such as diabetic ketoacidosis, diabetic hypertosmolar syndrome.
- •Subjects were able and willing to ues CGMS and eat regularly.
- •Patients who were able to inject insulin themselves or actual injections can be accompanied.
排除标准
- •Insulin allergy.
- •There has been a history of drug abuse and alcohol dependence in the past five years, or systemic hormone therapy within 3 months.
- •Patients with poor compliance and irregular eating and exercise.
- •Infection or stress within four weeks.
- •Patients unable to tolerate CGMS.
- •patients with pregnancy, breast-feeding, planning to have a baby
- •patients with coagulopathy, serious complication,such as cardiovascular disease, end stage renal disease; and patients with severe retinopathy or other eye problems that impair their visual function, or cognitive dysfunction
结局指标
主要结局
the relationship between HbA1C and injection score
时间窗: 6 DAYS
the relationship between HbA1C and injection score
The primary endpoint was the relationship between MAGE and injection score
时间窗: 6 DAYS
the relationship between the 24-h mean amplitude of glycemic excursions (MAGE) and injection score
the relationship between SDBG and injection score
时间窗: 6 DAYS
the relationship between SDBG and injection score
次要结局
- the relation between insulin antibodies and glucose excursions(6 DAYS)