NCT02082028已完成不适用
Randomized Clinical Trial on the Efficacy of Self-Monitoring Blood Glucose in the Context of a Chronic Care Model for Type 2 Diabetes Patients Treated With Oral Agents Only
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 241
- 试验地点
- 23
- 主要终点
- Change in HbA1c levels from baseline
研究概览
简要总结
To demonstrate the superiority of a chronic care model (SINERGIA model) supported by the Self Monitoring of Blood Glucose with BGStar over usual care in improving glycemic control at 12 months in patients with type 2 diabetes not treated with insulin.
详细描述
The planned study duration is 36 months (9 quarters). The estimated duration of screening/enrollment will be 12 months, followed by the 12-month experimental phase, plus the 12-month follow-up in the observational phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Age ≥ 45 years
- •Type 2 diabetes
- •First access at the diabetes clinic
- •Any diabetes duration
- •HbA1c >7.0 and ≤ 9.0%
- •Already treated with any oral antidiabetic agent (OAD) or requiring the initiation of therapy with OAD
- •Patients not using SMBG or using SMBG with a frequency ≤1 test/week
- •Written informed consent
排除标准
- •Treatment with insulin or need to start insulin regimens or continuous sub-cutaneous insulin infusion at the first access; Refusal or inability to give informed consent to participate in the study;
- •Conditions / situations such as:
- •Patients with short life expectancy;
- •Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment;
- •Requirement for concomitant treatment that could bias primary evaluation (i.e. corticosteroid treatment);
- •Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study;
- •Current addition/abuse of alcohol or drugs;
- •Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study;
- •Pregnant or breast-feeding women;
- •Patients living too far from investigational center or other conditions reducing the adherence to the protocol; Subjects unlikely or unable to comply with the Protocol requirements (e.g. illiterate, uncooperative, unable to return for follow-up visit, unable to use BGStar unlikely to complete the study)
结局指标
主要结局
Change in HbA1c levels from baseline
时间窗: baseline to 12 months
次要结局
- Variation in body weight from baseline(at 12 months and 24 months)
- Variation in waist circumference from baseline(at 12 months and 24 months)
- Variation in blood pressure from baseline(at 12 months and 24 months)
- Variation in lipid profile from baseline(at 12 months and 24 months)
- PDM (Patient involvement in the Decision Making process) questionnaire(at 12 months and 24 months)
- Percentage of participants with HbA1c ≤7.0%(at 12 months and 24 months)
- Quality of life: SF12 (Health Survey) questionnaire(at 12 months and 24 months)
- ADDQOL (Audit of Diabetes-Dependent Quality of Life)(at 12 months and 24 months)
- DTSQ (Diabetes Treatment Satisfaction Questionnaire)(at 12 months and 24 months)
- ABIM-14 (American Board of Internal Medicine satisfaction questionnaire)(at 12 months and 24 months)
- PHCO (Patient Health Care Orientation) questionnaire(at 12 months and 24 months)
- Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)(at 12 months and 24 months)
研究者
研究点 (23)
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