Glu-COACH: a Peer-mentoring Intervention to Reduce Disparities in Continuous Glucose Monitor (CGM) Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Mean hours per week CGM worn
研究概览
简要总结
This is a study to develop and evaluate a peer mentoring intervention for Black and Latinx adolescents with type 1 diabetes to increase the initiation and maintenance of a continuous glucose monitoring (CGM) device. This device is a standard of care to improve diabetes management related to diet, exercise, and insulin. Use of CGM has been shown to improve health outcomes, but is not used by adolescents of color. Peer mentors may help improve usage.
详细描述
In Phase 1, investigators developed the intervention with a stakeholder advisory group. In Phase 2, investigators will conduct a small clinical trial to evaluate the intervention. Phase 1 is complete with the focus of this registration being Phase 2, the clinical trial.
All study procedures will be conducted remotely by ZOOM, including consent/assent, device and training, and peer mentor sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes, as determined clinically by the presence of ketosis or ketoacidosis at presentation and/or the presence of at least one diabetes-related auto-antibody
- •Self-identification as Black and/or Latinx.
- •Ability of participant to comprehend and communicate in written and spoken English, in order to complete surveys and participate in mentioning sessions and other interview (parents/caregivers do not need to have English fluency)
- •Access to personal cellphone or tablet to participate in remote video sessions with the peer mentor
- •using CGM <50% of the time over the last 3 months
排除标准
- •Participants with a prior severe skin reaction to CGM sensor or adhesive.
- •Current use of CGM
- •Current or planned pregnancy
- •Inability to comprehend or communicate in spoken/written English
- •Subjects with other medical or mental health conditions that would, in the opinion of the investigators, interfere with the conduct of the study or present additional risk to the individual.
结局指标
主要结局
Mean hours per week CGM worn
时间窗: 3 months and 6 months
Mean hours per week of documented CGM wear. This will be documented through the CGM program. The primary analysis will be CGM use time at 6 months between the two groups.
次要结局
- CGM Mean glucose(baseline, 3 months and 6 months)
- CGM Percentage time in range (70-180mg/dL)(baseline, 3 months and 6 months)
- Number of Adverse diabetes-related events (severe hypoglycemia)(baseline, 3 months and 6 months)
- Mean score in Diabetes Distress using Problem Areas in Diabetes-Teen (PAID-T) survey(baseline, 3 months and 6 months)
- Mean score Diabetes self-efficacy using Diabetes Management Self-Efficacy scale (DMSES)(baseline, 3 months and 6 months)
- Mean score Family conflict using Diabetes Family Conflict Scale (DFCS)(baseline, 3 months and 6 months)
- Mean A1C concentration(baseline, 3 months and 6 months)
- Mean score Benefits and burdens of CGM use(baseline, 3 months and 6 months)
- Number of Adverse diabetes-related events (diabetic ketoacidosis)(baseline, 3 months and 6 months)
- Mean score Depressive symptoms using Patient Health Questionnaire-2 (PHQ-2)(baseline, 3 months and 6 months)
- Mean score Glu-Coach satisfaction scale(3 months and 6 months)
- Mean score Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)(baseline, 3 months and 6 months)
- Mean Score Technology Attitudes(baseline, 3 months and 6 months)
- Mean count Barriers to Device Use(3 months and 6 months)