Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Participant Satisfaction With Continuous Glucose Monitoring
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •A1C Glucose Measurement between 5.7 to 6.4 (for most recent A1C test, not older than 1 year)
- •No diabetes medication including Metformin
- •BMI (body mass index) >30
- •Must speak, read, and 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
排除标准
- •previous bariatric surgery
结局指标
主要结局
Participant Satisfaction With Continuous Glucose Monitoring
时间窗: 60 days (30 days after visit 3 completion)
Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.
Participant Satisfaction With Continuous Glucose Monitoring (CGM)
时间窗: 33 days after day 1 (visit 3 completion)
Satisfaction is measured using responses to the post intervention survey question, "How likely are you to recommend that a friend or family member with pre-diabetes wear a continuous glucose monitor (CGM)?". A 5 point scale was used, ranging from 1 to 5, where a score of 1 is "extremely likely" and 5 is "would not recommend". Satisfied respondents answered either 1 or 2 on the scale.
次要结局
- Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call(Approximately 5 days each new sensor is placed (days 5 and 16))
- Change in Knowledge of Low Carbohydrate Eating(baseline, day 22)
- Feasibility, Measured by Recruitment(3 months)
- Weight Change(day 11 (visit 2), day 22 (visit 3))
- Change in Cravings From Day 11 to Day 22(11 days)
- Intention to Continue Low Carbohydrate Eating(day 22)
- Change in Percentage of Time Glucose is Above 140(33 days after day 1)
- Feasibility of Pre-diabetic Patients to Wear CGM Sensors(completed within 60 days of enrollment)
- Utility of CGM Feedback for Changing Diet(60 days (30 days after visit 3 completion))
- Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log(days 11 through 22)
研究者
Caroline Richardson
Dr Max and Buena Lichter Research Professor of Family Medicine, Assistant Chair, Department of Family Medicine and Professor of Family Medicine, Medical School
University of Michigan