Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | October 15, 2018 | ||
| 预计主要完成日期 | October 15, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Participation Satisfaction with Continuous Glucose Monitoring[ Time Frame: 33 days after day 1 (visit 3 completion) ] This will be measured by the post intervention survey for How likely are you to recommend that a friend or family member with pre-diabetes wear a continuous glucose monitor (CGM). Participation Satisfaction with Continuous Glucose Monitoring[ Time Frame: 60 days (30 days after visit 3 completion) ] Qualitative themes related to participant satisfaction with CGM coded form post intervention interview. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes | ||
| 正式标题 ICMJE | Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes | ||
| 简要概况 | This study will recruit pre-diabetic patients to see if continuous glucose monitoring (CGM) with a low carbohydrate diet can reduce the percentage of time the CGM readings are above the normal range. Through this study it will demonstrate the feasibility of using CGM with a low carbohydrate diet to reduce weight and risk of developing diabetes in patients with pre-diabetes. Patients that appear to be eligible will be recruited from Michigan Medicine in the Family Medicine Clinic at the Livonia Center. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
15 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 15, 2019 | ||
| 预计主要完成日期 | October 15, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - A1C 5.7 to 6.4 (Most Resent A1C, not older than 1 year) - No diabetes medication including Metformin - BMI (body mass index) >30 - Must speak, read, adn write in English - No current pregnancy or breastfeeding - Must not classify as either Vegan or Vegetarian - Must be a patient at the Livonia Health Center Exclusion Criteria: - previous bariatric surgery | ||
| 性别 |
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| 年龄 | 最小年龄:21 Years ,最大年龄:N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: Yes |
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| IPD 共享声明 |
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| 责任方 | Caroline Richardson,University of Michigan | ||
| 研究赞助商 ICMJE | University of Michigan | ||
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| PRS 账户 | University of Michigan | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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