A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 522
- 试验地点
- 29
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12
研究概览
简要总结
This randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. Patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose analysis system. The effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline HbA1c values at 12 months. The anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >= 25 years of age
- •Type 2 diabetes for >= 1 year
- •Hemoglobin A1c >= 7.5% and <=11%
- •Diabetes managed by exercise and diet, prescription oral medication or an injectable incretin mimetic
排除标准
- •Type 1 diabetes
- •On any type of insulin therapy at start of study
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12
时间窗: Baseline, Month 12
Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.
次要结局
- Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)(Baseline, Month 12)
- Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations(12 Months)
- Change From Baseline in Depression Severity (PHQ-8)(Baseline, Month 12)
- Change From Baseline in the Diabetes Distress Scale (DDS)(Baseline, Month 12)
- Change From Baseline in the World Health Organization (WHO-5) Well-being Index(Baseline, Month 12)
- Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day(12 Months)
- Glycemic Variability Pre and Post-Prandial Excursions at Each Meal(Month 1, Month 12)