Study on the Feasibility of Community Doctors Guided by Specialists to Use Basic Insulin
2020年9月11日 更新者：Shenzhen Second People's Hospital
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
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.
研究概览
详细说明
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.
Follow-up requirements: Patients use the complimentary blood glucose meter to monitor FPG every day, 2 hours postprandial blood glucose and night blood glucose are optional, and blood sugar is measured at any time if there are symptoms of hypoglycemia. The community doctor adjusted the insulin dose according to the blood glucose level every day, and the patients were followed up by telephone every week to collect the use of hypoglycemia, diet, exercise and other hypoglycemic drugs, and record the time when the FPG reached the standard, the total amount of insulin glargine, hypoglycemia and so on.
研究类型
介入性
注册 (预期的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
其他名称：
|
|
有源比较器：inpatient group
Endocrinologists in the in-patient department use the same basic insulin dose adjustment regimen to treat patients.
|
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to achieve target FBG
大体时间：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.
|
From the beginning of intervention to fasting blood glucose ≤ 7.0mmol/L，assessed up to 3 months.
|
|
Decrease of HbA1c
大体时间：At the end of 3 months of follow-up.
|
The change of HbA1c before and after treatment with basal insulin.
|
At the end of 3 months of follow-up.
|
|
Incidence of hypoglycemia
大体时间：At the end of 3 months of follow-up.
|
The proportion of the occurrence of hypoglycemia to the number of total blood glucose monitoring.
|
At the end of 3 months of follow-up.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Daily doses of insulin at the study end point.
大体时间：At the end of 3 months of follow-up.
|
The daily doses of insulin at the study end point.
|
At the end of 3 months of follow-up.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Dewen Yan、Shenzhen Second People's Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.
- Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, DeFronzo RA, Einhorn D, Fonseca VA, Garber JR, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez GE. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2019 EXECUTIVE SUMMARY. Endocr Pract. 2019 Jan;25(1):69-100. doi: 10.4158/CS-2018-0535. No abstract available. Erratum In: Endocr Pract. 2019 Feb;25(2):204.
- Ji L, Zhang P, Weng J, Lu J, Guo X, Jia W, Yang W, Zou D, Zhou Z, Pan C, Gao Y, Li X, Zhu D, Li Y, Wu Y, Garg SK. Observational Registry of Basal Insulin Treatment (ORBIT) in Patients with Type 2 Diabetes Uncontrolled by Oral Hypoglycemic Agents in China--Study Design and Baseline Characteristics. Diabetes Technol Ther. 2015 Oct;17(10):735-44. doi: 10.1089/dia.2015.0054. Epub 2015 Jul 14.
- American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S98-S110. doi: 10.2337/dc20-S009. Erratum In: Diabetes Care. 2020 Aug;43(8):1979.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年12月1日
初级完成 (预期的)
2021年12月31日
研究完成 (预期的)
2022年3月31日
研究注册日期
首次提交
2020年9月3日
首先提交符合 QC 标准的
2020年9月11日
首次发布 (实际的)
2020年9月17日
研究记录更新
最后更新发布 (实际的)
2020年9月17日
上次提交的符合 QC 标准的更新
2020年9月11日
最后验证
2020年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.