Glucose, Understanding, Integrated Digital Health, and Engagement (GUIDE) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mean Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to evaluate whether an Integrated Digital Health (IDH) intervention with and without healthcare provider engagement, improves glycemic control and diabetes-related outcomes among adults with Type 2 diabetes. The study will also assess the feasibility of integrating this approach into routine primary care to support personalized, data-informed diabetes management.
详细描述
Participants will complete a total of three study visits: a baseline visit (which includes consent, screening, and enrollment procedures), a 16-week follow-up visit, and a 32-week follow-up visit. Each study visit is expected to last approximately 30 minutes. In addition, participants will complete study surveys throughout the study period, which are expected to require approximately 30-40 minutes per survey. Depending on study group assignment, participants may also use study devices and mobile applications to track health behaviors and/or participate in telehealth visits with a healthcare provider. The frequency and duration of these activities will vary by study group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of T2D for at least one year
- •recent 3 month-HbA1c, 8-11%
- •ownership of a smartphone
- •English or Spanish speaking.
排除标准
- •not available or willing to use CGM or study device/platform
- •serious medical conditions or active thought disorders (e.g., terminal cancer, schizophrenia)
- •In addition to the self-report of the HbA1c within the past 3 months, potential participants will be screened with a point-of-care (POC) HbA1c (A1CNow®+).
结局指标
主要结局
Mean Hemoglobin A1c (HbA1c)
时间窗: Baseline, 16 weeks and 32 weeks
HbA1c in milligrams per deciliter (mg/dL) will be measured using blood testing conducted according to the standardized procedures of the National Glycohemoglobin Standardization Program (NGSP).
Mean Glucose Variability (Coefficient of Variation [%CV])
时间窗: Baseline, 16 weeks and 32 weeks
Glucose variability will be derived from continuous glucose monitoring (CGM) data and calculated as the coefficient of variation (CV = standard deviation/mean glucose × 100). This measure reflects intra- and inter-day fluctuations in glucose levels. Consistent with consensus recommendations, a CV ≤36% is considered stable glucose variability.
Percentage of glucose readings with Time in Range (TIR)
时间窗: Baseline, 16 weeks and 32 weeks
TIR will be derived from CGM data and calculated as the percentage of glucose readings and time per day within the target glucose range of 70-180 mg/dL (3.9-10.0 mmol/L). Consistent with consensus recommendations, a TIR ≥70% is considered an indicator of optimal glycemic management.
次要结局
- Mean score Revised Summary of Diabetes Self-Care Activities (SDSCA)(Baseline, 16 weeks and 32 weeks)
- Mean score Diabetes Management Self-Efficacy Scale(Baseline, 16 weeks and 32 weeks)
- Mean score Diabetes Distress Scale(Baseline, 16 weeks and 32 weeks)
- Mean score Diabetes Quality of Life Brief Clinical Inventory(Baseline, 16 weeks and 32 weeks)