Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients
2021年2月3日 更新者：Caroline Richardson、University of Michigan
Achieving Improved Control of Blood Glucose Among Type 2 Diabetes Patients Through Continuous Glucose Monitoring & Care Coordinator Mediated Gains in Patient Self-Management Sophistication
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).
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
64
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Michigan
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Chelsea、Michigan、美国、48118
- Chelsea Health Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
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Usual care from Primary Care Physician and dietitian.
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有源比较器：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.
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Usual care from Primary Care Physician and dietitian.
|
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实验性的：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.
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The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.
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实验性的：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.
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Usual care from Primary Care Physician and dietitian.
Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hemoglobin A1C
大体时间：1 year
|
Hemoglobin A1C
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weight Change
大体时间：baseline to 1 year
|
Difference in patient's weight measured in pounds.
|
baseline to 1 year
|
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Change in diabetes medication requirements
大体时间：baseline to 1 year
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Change in average daily doses of diabetes medications
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baseline to 1 year
|
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Change in percentage of time glucose is out of range
大体时间：baseline to 1 year
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Change in percentage of time glucose is out of range (70 mg/dl-140 mg/dl) on CGM.
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baseline to 1 year
|
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Blood Pressure
大体时间：1 year
|
Blood Pressure
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1 year
|
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Change in rate of Micro-vascular complications
大体时间：Baseline to 1 Year
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Change in rate of micro-vascular complications.
(The micro-vascular complications assessed will be retinopathy, neuropathy, nephropathy)
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Baseline to 1 Year
|
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Change in rate of symptomatic hypoglycemia requiring medical intervention
大体时间：Baseline to 1 year
|
Change in rate of symptomatic hypoglycemia requiring medical intervention
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Baseline to 1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Caroline Richardson, M.D.、University of Michigan
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年11月26日
初级完成 (实际的)
2020年2月7日
研究完成 (实际的)
2021年1月20日
研究注册日期
首次提交
2018年10月8日
首先提交符合 QC 标准的
2018年10月10日
首次发布 (实际的)
2018年10月15日
研究记录更新
最后更新发布 (实际的)
2021年2月4日
上次提交的符合 QC 标准的更新
2021年2月3日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Usual Care的临床试验
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Arizona State UniversityMayo Clinic; National Institute of Nursing Research (NINR)完全的
-
The University of Texas Health Science Center,...Tufts University; American Heart Association; Michael and Susan Dell Foundation招聘中
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Fondazione Don Carlo Gnocchi OnlusIstituto Di Ricerche Farmacologiche Mario Negri完全的
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Copenhagen University Hospital at HerlevRigshospitalet, Denmark未知
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Fondation Oeuvre de la Croix Saint-Simon撤销
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University Health Network, Toronto招聘中淋巴瘤 | 淋巴增生性疾病 | 乳腺癌一期 | 乳腺癌二期 | 结直肠癌 II 期 | 结直肠癌 III 期 | 乳腺癌三期 | 结直肠癌 I 期 | 头颈癌 III 期 | 乳腺癌，0 期 | 头颈癌 I 期 | 头颈癌 II 期加拿大
-
Emory UniversityFoundation for Physical Therapy, Inc.完全的