Protocol: Comparing the Effect of Using an Internet-Based Glucose Monitoring System Versus the Continuous Glucose Monitoring System on HbA1c Levels in Type 2 DM
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint is the A1c level or the change in A1c level
研究概览
简要总结
Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In order to prevent short and long term complications, patients need to monitor and control their blood sugar levels. In addition, they may need to have an ongoing communication with their doctor in order to modify treatment. In this study the investigators wish to compare two systems of monitoring and communication of blood sugar levels. The first is the use of continuous glucose monitoring system and the second is the use of an Internet-based glucose monitoring system. The investigators want to compare their effect and/or benefits.
详细描述
Purpose: To compare the benefits of the Internet-based glucose monitoring system with the Continuous Glucose monitoring system in patients with type 2 diabetes mellitus.
Hypothesis:The investigators propose that the benefits from the Internet-based glucose monitoring system (IBGMS) will be comparable to the benefits of the Continuous Glucose monitoring system (CGMS) for patients with type 2 DM.
Justification: Half of the subject will be on the standard treatment, which will involve glucose monitoring by testing blood glucose 3 times daily, performing a laboratory test of blood hemoglobin every three months, and visiting the doctor every three months for standard care. They will also use the internet system to report their glucose readings,which will allow the health care professions to view the results and provide feedback. The other half will use the continuous glucose monitoring system, which will involve a minimum of testing blood glucose at least 2 times a day to calibrate the sensor, performing laboratory test of blood hemoglobin every three months, and visiting the doctor every three months for standard care. All of the subjects will be under standard care;
Research Method: Type 2 diabetes patients who satisfy the inclusion criteria will be recruited from St. Paul's Diabetes Teaching and Training Centre. They will be randomized into 2 groups (IBGMS and CGMS). There is an equal chance, a 50/50 chance, of being placed in either group.
The IBGMS group will receive standard care and will be asked to perform self-blood glucose monitoring 3 times daily for 6 months. The IBGMS group will also be asked to report their blood glucose reading every 2 weeks through an Internet based glucose monitoring system. The IBGMS group will make visits to the endocrinologist every 3 months with A1c and serum creatinine measurements at 3-month intervals for 6 months.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients being treated with insulin for at least 3 months
- •HbA1c > 7%
- •> 25 years of age
- •Willingness to test blood glucose levels a minimum of 3 times daily
- •Willingness to be trained on using the Continuous Glucose Monitoring System
- •Willingness to be randomized
- •Trained in self-blood glucose monitoring
- •Internet Access on a Windows Personal Computer
- •No prior use or training on CGMS in the past 6 months
- •No prior use or training on IBGMS in the past 6 months
排除标准
- •Patients who do not meet the above criteria or are not willing to participate will not be included in the study. Additional exclusion criteria include:
- •Patient with medical conditions that may affect their study participation or results will be excluded.
- •Patients with the potential to become pregnant
- •Patients using medications known to influence control of diabetes (eg steroids systemic or inhaled)
- •Liver disease (AST or ALT levels > 2.5 times the reference level)
- •Renal insufficient with a serum creatinine level > 200 μmol/L
结局指标
主要结局
The primary endpoint is the A1c level or the change in A1c level
时间窗: 6 Months
次要结局
- The secondary endpoint include severe hypoglycemia defined as requiring external aid (hospital or other).(6 Months)
- A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours(6 monthns)
研究者
Dr. Hugh Tildesley
Clinical Professor
Endocrine Research Society