Investigating if an Internet-Based Glucose Monitoring System is as Effective as Medication at Reducing HbA1c Levels in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HbA1c Levels before and after intervention
研究概览
简要总结
Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize health problems and complications. One way for patients to notify doctors and receive feedback about their blood sugar management is through an online system. As Internet-based glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators hypothesize that IBGMS is effective as an intervention even when limiting feedback to non-medicine related changes.
详细描述
- Purpose:
To determine the effectiveness of an Internet-based glucose monitoring system (IBGMS) in the absence of medication changes. 2. Hypothesis:
IBGMS without medication changes is comparable to conventional medication at reducing HbA1c levels over 8% in patients with T2DM. 3. Justification:
Patients with T2DM having elevated HbA1c levels may be prescribed additional medications to help manage their blood sugar levels, which include oral hypoglycemic agents and/or insulin. As IBGMS has been shown to be effective in reducing HbA1c in T2DM, there is an opportunity to determine whether if this system could be used as an alternative to medication.
The benefits would include reduced side effects as a result of substituting for the effects of medication, as well as reduced financial costs associated with acquiring medication.
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
- •Type 2 diabetes patients being treated with oral hypoglycemic agents
- •HbA1c > 8%
- •Willingness to test blood glucose levels a minimum of 3 times daily
- •Willingness to be trained on using the Internet-Based Glucose Monitoring System
- •Willingness to be randomized
- •Trained in self-blood glucose monitoring
- •Internet access on a computer
- •No prior use or training on IBGMS
排除标准
- •Patient with medical conditions that may affect their study participation or results will be excluded.
- •Patients using medications known to influence control of diabetes (eg steroids systemic or inhaled)
- •Liver disease (AST (aspartate aminotransferase) or ALT (alanine aminotransferase) levels > 2.5 times the reference level)
- •Renal insufficient with a serum creatinine level > 200 μmol/L
研究组 & 干预措施
Internet-Based Glucose Monitoring System
The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and provide feedback limited to non-medicine related comments and suggestions.
干预措施: Internet-Based Glucose Monitoring System (Other)
Normal Medication Positive Control
The subjects will be prescribed a new medication as appropriate for normal therapy. This group will receive no biweekly feedback nor require to report online, but will see the endocrinologist every 3 months up to 6 months.
干预措施: Normal Medication Positive Control (Drug)
结局指标
主要结局
HbA1c Levels before and after intervention
时间窗: 6 months
Compare HbA1c Levels before and after intervention for both arms, as well as the difference in HbA1c Levels between arms.
次要结局
- HbA1c levels remain at 8% or higher(3 months)
- 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 months)
研究者
ERS Gap Student
Medical Director
Endocrine Research Society