NCT02432391已完成不适用
Self-Monitoring of Blood Glucose (SMBG) as an Educational Tool and a Negative Feedback Loop to Reinforce Blood Glucose Lowering and Discourage Blood Glucose Elevating Self-Management Behaviors in Adults With T2DM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change from baseline glycosylated hemoglobin at 6 months
研究概览
简要总结
The purpose of this study is to determine if a lifestyle modification program (GEM) that focuses on reducing after-meal blood glucose elevations can improve blood glucose control in people with type 2 diabetes. Half of the participants will continue their routine medical care, and half will receive five sessions of GEM in addition to their routine care. The two groups will be assessed using diabetes-relevant medical, behavioral and psychological measures.
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
- 24 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes within the past 5 years
- •Age >24 and <80 years
- •HbA1c >7.0%
- •Approval of primary care physician to participate
排除标准
- •Currently using, or used within the last 3 months, medications that directly lower BG (e.g., insulin, sulfonylureas, glinides, or DPP-4 inhibitors).
- •Currently using, or used within the last 3 months, thiazides at doses above HCTZ 25 mg or equivalent, or loop diuretics above furosemide 20mg or equivalent.
- •Currently pregnant or contemplating pregnancy in the coming year
- •Currently using, or used within the last 3 months, medications that impede weight loss (e.g., prednisone)
- •Having conditions that preclude increasing physical activity, e.g. severe neuropathy, active cardiovascular disease, emphysema, osteoarthritis, stroke.
- •Undergoing cancer treatment
- •History of lactic acidosis
- •Diagnosed with renal impairment
结局指标
主要结局
Change from baseline glycosylated hemoglobin at 6 months
时间窗: 0 and 6 months
HbA1c
次要结局
未报告次要终点
研究者
Daniel Cox, PhD
Professor, Department of Psychiatry and NB Sciences
University of Virginia
研究点 (2)
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