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
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
- 20
- 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)
研究组 & 干预措施
A (BGStar)
Patients will be educated within the context of the SINERGIA educational program to understand how to manage their own diabetes on the basis of their Self Monitoring of Blood Glucose values obtained with BGStar. Patients will be requested two 6-points profiles monthly.
干预措施: BGStar (Device)
B (traditional approach)
Usual approach for the disease management. Patients in Group B will receive usual education and, at any time during the study duration, if needed, will be instructed on Self Monitoring of Blood Glucose, performed with any glucose meter.
干预措施: glucose meter (Device)
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
- ADDQOL (Audit of Diabetes-Dependent Quality of Life)(at 12 months and 24 months)
- 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)
- 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)
- PDM (Patient involvement in the Decision Making process) questionnaire(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)