Continuous Glucose Monitors in the Management of Youth With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- CGM Acceptability
研究概览
简要总结
We are evaluating whether intermittent use of continuous glucose monitors (CGMs) in addition to standard nutritional counseling and physical activity counseling is associated with improved metabolic health for youth with pre-diabetes (PD).
详细描述
The purpose of this research study is to test if CGMs are tolerable to youth with pre-diabetes (PD) and their caregivers. We are also evaluating if CGMs add benefit to standard treatment in youth with prediabetes. The CGM in question, Abbott Freestyle Libre 2 is approved by the Food and Drug Administration (FDA) to treat patients aged 4 and up with diabetes. We want to determine if this CGM may benefit people who have PD. People who enter the study will either receive standard medical care for prediabetes or receive standard medical care for prediabetes plus use a CGM for 2 weeks each month to receive real-time biofeedback on their glucose levels during the day.
There will be 3 visits over a 6-month period, baseline, 3-month, and 6-month visits. At each visit fasting labs will be obtained including: complete metabolic panel, lipid panel, pro-insulin, c-peptide, insulin. Anthropomorphics including body mass index, waist circumference, and hip circumference will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 11 or older
- •English-speaking
- •stable metformin dose for 1 month prior to enrollment or no metformin use
- •baseline A1c of 5.7-6.4%
- •BMI > = 85% for age
排除标准
- •BMI < 85% for age
- •chronic steroid use
- •diagnosis of type 1 diabetes, type 2 diabetes, other forms of diabetes
- •current or history of malignancy
研究组 & 干预措施
CGM + Traditional Counseling
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
干预措施: Abbott Freestyle Libre 2 (Device)
CGM + Traditional Counseling
Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
干预措施: Standard physical activity and nutritional counseling for prediabetes management (Other)
Caregivers of CGM + Traditional Counseling Group
Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group.
Control
Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform.
干预措施: Standard physical activity and nutritional counseling for prediabetes management (Other)
结局指标
主要结局
CGM Acceptability
时间窗: 6 months
Caregiver and patient acceptability of CGM use
Change in Measured % HbA1c From Baseline to 6-months
时间窗: 6 months
The difference in measured percentage of glycosylated hemoglobin (hemoglobin A1c) was obtained by subtracting the 6-month value from the baseline value for all subjects with paired data available. A negative result indicates a reduction (improvement) in hemoglobin A1c over the period.
次要结局
- Change in HOMA-IR From Baseline to 6-months.(6 months)
- Change in Triglyceride, HDL, LDL, and Total Cholesterol From Baseline to 6-month(6 months)
- Changes in Liver Enzymes From Baseline to 6-months.(6 months)
- Glycemic Metrics(6 months)
研究者
Jessica Schmitt
Assistant Professor
University of Alabama at Birmingham