NCT03705260已完成不适用
Achieving Improved Control of Blood Glucose Among Type 2 Diabetes Patients Through Continuous Glucose Monitoring & Care Coordinator Mediated Gains in Patient Self-Management Sophistication
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
The goal of the Twine / University of Michigan Diabetes Quality Improvement Initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (CGM) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (T2D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Michigan Medicine patient treated by a physician in the Family Medicine Department at the Chelsea Health Center
- •Diagnosis of T2D as recorded in the patient's problem list or as documented by medication list and lab results
- •HbA1C >8 for the high-risk sub-cohort
排除标准
- •Individuals for whom tight control (ie A1C < 8) is not safe or recommended, including but not limited to older frail individuals at high-risk of hypoglycemia and falls or those with a life expectancy of less than 6 months due to a comorbid condition
- •Individuals with cognitive or psychological diagnoses that might make CGM or low carbohydrate dieting risky, such as patients with eating disorders, uncontrolled psychotic - mental illness or those patients with dementia
- •Women who are pregnant or breast feeding
- •Individuals who had previous bariatric surgery
结局指标
主要结局
Hemoglobin A1C
时间窗: 1 year
Hemoglobin A1C
次要结局
- Change in rate of Micro-vascular complications(Baseline to 1 Year)
- Change in percentage of time glucose is out of range(baseline to 1 year)
- Weight Change(baseline to 1 year)
- Change in diabetes medication requirements(baseline to 1 year)
- Change in rate of symptomatic hypoglycemia requiring medical intervention(Baseline to 1 year)
- Blood Pressure(1 year)
研究者
Caroline Richardson
Professor
University of Michigan
研究点 (2)
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