Diabetes Prevention by Group Intervention and CGM Use in Pre-diabetic Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- That pairing real-time physiologic feedback from CGMs with the structured curriculum, peer accountability, and multidisciplinary support will facilitate meaningful lifestyle changes and better metabolic control in this population.
研究概览
简要总结
This study is being done to find better ways to help people with prediabetes prevent or delay the development of type 2 diabetes. Prediabetes means your blood sugar is higher than normal, but not high enough to be diagnosed with diabetes. It is often silent, but without changes in diet and activity, many people progress to a diagnosis of diabetes within a few years.
The study combines two strategies:
- Group visits - small, regular meetings where patients learn about healthy eating, physical activity, and stress management.
- Continuous Glucose Monitors (CGMs) - small wearable sensors that measure blood sugar all day and show how food, movement, and sleep affect it in real time.
By bringing these two tools together, the research hopes to help participants better understand their own bodies and make lasting lifestyle changes.
What is the purpose of this research?
The purpose of this research is to find out whether using a CGM device together with group sessions can help people with prediabetes lower their average blood sugar (measured by A1C) and improve confidence in managing their health.
详细描述
The purpose of this study is to evaluate whether combining continuous glucose monitoring (CGM) with group meetings produces improved outcomes in patients with prediabetes. The central hypothesis is that pairing real-time physiologic feedback from CGMs with the structured curriculum, peer accountability, and multidisciplinary support will facilitate meaningful lifestyle changes and better metabolic control in this population. Specifically, the research questions are:
Among patients with prediabetes, does participation in a program that integrates CGMs with group meetings lead to improvements in clinical outcomes such as fasting glucose, HbA1c, and weight compared to baseline measures?
Does the combined use of CGMs and SMAs enhance psychosocial outcomes such as self-efficacy, readiness to change, and adherence to lifestyle modifications in patients with prediabetes?
Does the integration of CGMs into lifestyle change program increase participant engagement and attendance compared to program alone?
It is well known that long-term and personalized lifestyle support reduces T2DM. There is also demonstrated efficiency of continuous glucose monitors (CGM) in diabetic patients. CGMs can provide real-time feedback on lifestyle choices and glycemic responses, acting as a behavior changing tool. This study aims to combine shared medical appointments (SMA) and CGM feedback, focusing on prevention of diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Prediabetes by a physician based on A1c, fasting glucose or American Diabetes Association (ADA) Type 2 risk test.
- •18 to 75 years old inclusive.
排除标准
- •Non-English-Speaking individuals.
- •Diagnosed with Diabetes.
- •Use of glucose lowering medications (GLP-1, Metformin, etc.)
- •Pregnant women.
- •Unwilling to use Continuous Glucose Monitors (CGMs)
- •Unable to assist to the Group meetings in Conroe, TX.
研究组 & 干预措施
SMART
The intervention combines group sessions and CGM-based behavioral feedback. Group sessions will occur twice in month 1 and monthly thereafter at the SHSU clinic and will cover nutrition, movement, stress, sleep and habit formation. Study investigators will prepare and coordinate each meeting; additional presenters include a nutritionist, an exercise specialist (activity planning), and a behavioral health clinician. Participants will be using CGMs during the weeks 3-6 and 13-14 or 13-16.
干预措施: Combines group sessions and CGM-based behavioral feedback (Other)
结局指标
主要结局
That pairing real-time physiologic feedback from CGMs with the structured curriculum, peer accountability, and multidisciplinary support will facilitate meaningful lifestyle changes and better metabolic control in this population.
时间窗: 25 weeks
Among patients with prediabetes, does participation in a program that integrates CGMs with group meetings lead to improvements in clinical outcomes such as fasting glucose, HbA1c, and weight compared to baseline measures? Does the combined use of CGMs and SMAs enhance psychosocial outcomes such as self-efficacy, readiness to change, and adherence to lifestyle modifications in patients with prediabetes? Does the integration of CGMs into lifestyle change program increase participant engagement and attendance compared to program alone?
次要结局
未报告次要终点