Effect of Introducing Daily Paired Testing to Poorly Controlled Chinese Diabetes Patients on Glycemic Control and Self Care
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments.
研究概览
简要总结
This study aims is to evaluate the effect of introducing paired testing on actual testing frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled diabetes patients in China.
详细描述
Self monitoring of blood glucose (SMBG) in insulin treated type 1 and type 2 diabetics has consistently been demonstrated to confer benefits, and is considered an essential part in the management of diabetes. In China, utilization of SMBG among diabetes patients is low. Even among those who perform SMBG regularly, the daily testing frequency falls short of those recommended in international and national clinical guidelines. There is thus a need to create the awareness of the benefits of SMBG and at the same time establish a SMBG regimen that is deemed practically feasible and cost effective for diabetes patients.
Paired testing entails the act of measuring glucose level before and after an event that may impact the glucose level in a patient, e.g. meals, exercise, medication adjustment, and thereafter responding to any abnormal glucose levels/patterns by modifying lifestyle and/or medication.
This study aims is to evaluate the effect of introducing paired testing on actual testing frequency, glycemic control, psychosocial and behavioral aspects of poorly controlled diabetes patients in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosed with diabetes mellitus
- •HbA1c ≥ 8% measured within the a month prior to enrolment
- •Have not been performing SMBG on a regular (daily) basis within the 3 months prior to enrolment
- •Willing and able to use Accu-Chek® Active blood glucose meter to perform daily SMBG
- •Willing and able to complete participant questionnaires
- •Willing and able to visit the physician at month 3 and month 6
- •Provide informed consent prior to enrolling in the study
排除标准
- •Any retinopathy that required photocoagulation or retinal surgery in the 6 months prior to enrolment or that may require photocoagulation or retinal surgery during the study
- •Any clinically significant condition that required hospitalization in the last 2 months prior to enrolment or that may require hospitalization (e.g. elective surgery) during the study
- •Any clinically significant psychosis or cognitive impairment
- •Unlikelihood to comply or complete the study
- •Women who are pregnant, lactating or planning to become pregnant during the study period
研究组 & 干预措施
paired testing of blood glucose
Patient will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Paired testing arm will undergo paired testing of blood glucose.
干预措施: Paired testing of blood glucose Accu-Chek® (Device)
control arm
Non-insulin patients will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Patients in the control arms will not undergo paired testing and will be managed as before.
结局指标
主要结局
Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments.
时间窗: 6 months
次要结局
- Proportion of patients who achieve good glycemic control (HbA1c≤7%)(6 months)
研究者
Weiping Jia
The director of the endocrinology and metabolism department of the Shanghai 6th People's Hospital
Shanghai 6th People's Hospital