Study on the Feasibility and Treatment Experience of Community Doctors in Shenzhen Guided by Specialists to Use Basic Insulin in the Treatment of Adult Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Time to achieve target FBG
研究概览
简要总结
At present, one of the reasons for the low blood sugar control rate in China is related to the late use of basic insulin and insufficient dose adjustment. If the community hospital can actively treat the diabetic patients who need to use insulin and adjust the dose in time, it will certainly improve the blood sugar control rate. However, at present, community doctors basically do not take the initiative to start insulin treatment, but only passively use insulin that has been prescribed by specialists, and there is a lack of ability to adjust the dose of insulin and treatment inertia. Therefore, it is very necessary for community doctors to receive guidance from endocrine specialists to improve their ability to use insulin. This study intends to carry out a study of endocrine specialists guiding community doctors to use basic insulin in the treatment of adult type 2 diabetes in Shenzhen Community Hospital. Through this study to understand whether the effectiveness and safety of community doctors actively using basic insulin therapy under the guidance of specialists can reach the level of specialists.
详细描述
The study consists of two parts: the screening period and the treatment follow-up period.
- Screening period (day 0): patients were screened according to the inclusion and exclusion criteria, and informed consent was completed.
- Treatment follow-up period (day 1-day 90)： Day 1： （1）all patients in the group received diet and exercise education；（2）Collect patients' basic data (name, sex, age, height, weight, waist circumference, hip circumference, etc.), detect plasma FBG and HbA1c (sent to the central laboratory for testing)；（3）Initial treatment： On the basis of the original oral medicine, the patient will initial basic insulin. The initial dose of basic insulin is 0.2U/kg/d.
Day 2-Day 89:
- Community patient group：The community doctor adjusts the dosage of insulin daily according to the patient's FBG: the dose is titrated by increments of 0.07U/kg daily until the fasting blood glucose （FBG）≤7 mmol / L, and if the FBG≤ 3.9mmol/L, the 0.07U/kg is reduced. Inpatient group：Endocrinologists in the in-patient department use the same basic insulin dose adjustment regimen to treat patients.
- It can be discontinued when the basic insulin is reduced to 8U and the fasting blood glucose reaches the standard for 3 days.
Day 90：Patients were re-examined the plasma FBG and HbA1c (sent to the central laboratory for testing), and community doctors filled in the treatment experience questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T2DM (WHO1999 diabetes diagnostic criteria)；
- •The age is ≥ 18 and ≤ 65 years old;
- •Continuous use of 2 or more oral hypoglycemic drugs for 1 month but HbA1c ≥ 8.0% and FPG ≥ 10mmol/L.
排除标准
- •Severe abnormal liver and kidney function and cardiac insufficiency;
- •Complicated with all kinds of acute and chronic infection or coronary heart disease, kidney disease, connective tissue disease, tumor, stroke and so on;
- •There are acute metabolic disorders caused by stress and diseases affecting glucose metabolism, such as pheochromocytoma, acromegaly, Cushing syndrome, hyperthyroidism and so on.
- •Acute complications of diabetes, such as diabetic ketoacidosis, hyperglycemic hyperosmotic coma or lactic acidosis, etc.
研究组 & 干预措施
community patient group
The community doctor adjusts the basic insulin dosage daily according to the fasting blood glucose of the patient under the guidance of the specialist.
干预措施: basic insulin (Drug)
inpatient group
Endocrinologists in the in-patient department use the same basic insulin dose adjustment regimen to treat patients.
干预措施: basic insulin (Drug)
结局指标
主要结局
Time to achieve target FBG
时间窗: From the beginning of intervention to fasting blood glucose ≤ 7.0mmol/L，assessed up to 3 months.
Treatment days when FBG reached the standard (≤ 7.0mmol/L) after treatment with basal insulin.
Decrease of HbA1c
时间窗: At the end of 3 months of follow-up.
The change of HbA1c before and after treatment with basal insulin.
Incidence of hypoglycemia
时间窗: At the end of 3 months of follow-up.
The proportion of the occurrence of hypoglycemia to the number of total blood glucose monitoring.
次要结局
- Daily doses of insulin at the study end point.(At the end of 3 months of follow-up.)