Achieving Improved Control of Blood Glucose Among Type 2 Diabetes Patients Through Continuous Glucose Monitoring & Care Coordinator Mediated Gains in Patient Self-Management Sophistication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 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
研究组 & 干预措施
Comparator- High Risk
A high risk sub group of those assigned to the comparator arm will be identified by their most recent A1C > 8. Patients in this group will receive usual care from their Primary Care Physician and dietitian.
干预措施: Usual Care (Other)
Comparator- Well Controlled
The low risk sub group from the comparator arm (A1C < 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their Primary Care Physician and their dietitian.
干预措施: Usual Care (Other)
Enhanced Care- High Risk
A high risk sub group of those assigned to the enhanced care arm will be identified by their most recent A1C > 8. Patients in this group will receive the intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.
干预措施: Intensive Behavioral Intervention (Behavioral)
Enhanced Care- Well Controlled.
The low risk sub group from the enhanced care arm (A1C < 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their PCP and their dietitian. If they are found to be poorly controlled through monthly screening for risk, they may have the opportunity to move into the Enhanced Care High Risk group.
干预措施: Usual Care (Other)
Enhanced Care- Well Controlled.
The low risk sub group from the enhanced care arm (A1C < 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their PCP and their dietitian. If they are found to be poorly controlled through monthly screening for risk, they may have the opportunity to move into the Enhanced Care High Risk group.
干预措施: Monthly Screening for Risk (Other)
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