Continuous Glucose Monitoring (CGM) in Prediabetes With Health Education Videos
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Glucose levels
研究概览
简要总结
The objective of this project is to develop a behavioral intervention that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and educational video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with pre-diabetes. The goal is to prevent transition to type 2 diabetes (T2D).
详细描述
The primary objective of this new project is to enhance glycemic control in individuals with prediabetes and deter the progression to Type 2 Diabetes (T2D) within the Los Angeles (LA) County community. Our proposal involves conducting a Phase 0 intervention development study. This study will enlist a final sample of N=50 adults who speak English and/or Spanish, have non-clinical prediabetes, and test positive for prediabetes via a finger-prick A1c% screening. Participants will wear CGM devices for 20 days, with glucose data masked for the first 10 days and unmasked for the next 10 days. During the unmasked phase, participants will receive daily health education videos on their smartphones. The study will compare the duration of glucose excursions between the masked and unmasked phases to assess the impact of CGM feedback and health education on glucose regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Participants are blinded to glucose values during Phase A. The CGM system generates automated records of glucose and does not require observation from an outcomes assessor. The investigator does not engage with participants and becomes aware of unmasking after trial is completed.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •35 years of age or older
- •Willingness to wear CGM sensor
- •Prediabetes by finger prick blood A1C% or fasting glucose
- •Centers for Disease Control and Prevention (CDC) prediabetes risk test score of 5 or higher or recent prediabetes diagnosis from physician
排除标准
- •Diagnosed with any disorder that interferes with glucose
- •Influential medical disorder/event affecting ability to participate in study
- •Incompatible smartphone device not pairing with Dexcom G6 app
- •Currently pregnant
- •Previously participated in other Continuous Glucose Monitoring studies
- •Having a planned trip outside California in the following 2 months
研究组 & 干预措施
Single Group: CGM with Masked Phase A and Unmasked Phase B
Participants wear a CGM on the back of the arm. During Phase A, glucose values are not visible to participants. During Phase B, glucose values are visible via the phone app.
干预措施: CGM (Device)
结局指标
主要结局
Glucose levels
时间窗: Maximum of 20 days of continuous wear
Mean glucose in mg/dL
次要结局
- Time out of range > 140 mg/dL (TOR)(Maximum of 20 days of continuous wear)
研究者
David S Black, PhD
Tenured Associate Professor of Population and Public Health Sciences
University of Southern California