Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score
研究概览
简要总结
This clinical trial studies the effect of a continuous glucose monitor application in improving outcomes in patients with poorly controlled type 2 diabetes and active cancer. Patient satisfaction with type 2 diabetes management influences medication-taking behavior as well as health outcomes. Adding continuous glucose monitor application to diabetes treatment plan after hospital discharge plan may improve patient satisfaction and reduce diabetes distress.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate if addition of continuous glucose monitor (CGM) to diabetes treatment plan following inpatient hospitalization is associated with improved patient satisfaction with DM management in patients with cancer and poorly controlled type 2 diabetes mellitus.
SECONDARY OBJECTIVES:
I. Evaluate feasibility of CGM initiation upon hospital discharge. II. Evaluate effect of CGM on recognition of post-hospitalization hypoglycemia. III. Evaluate patient reported outcome of CGM incorporation into patient diabetes care burden.
IV. Evaluate effect of CGM on depression score before and after CGM use.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Insulin use > 10 units per day
- •Hemoglobin A1c > 8.5%
- •Smart phone compatible with LibreView App
排除标准
- •Type 1 diabetes mellitus (DM)
- •Inability to consent
- •Pregnancy
- •Prisoners
- •Discharge to skilled nursing facility
结局指标
主要结局
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score
时间窗: From baseline to 4 weeks post-discharge
Descriptive statistics will summarize the sample characteristics and distribution of each variable. Change over time in continuous variables will be reported as paired t-test or nonparametric test as appropriate.
次要结局
- Change in various measures of control(From week 1 to week 4)
- Change in DTSQ scores(From baseline to 2 weeks post-discharge)
- Overall control(Up to 4 weeks post-discharge)
- Number of patients with successful data collection(At 4 weeks)
- Change in Patient Health Questionnaire scores(From baseline to 4 weeks post-discharge)
- Incidence of adverse events(Immediately following inpatient hospitalization)
研究者
Kathleen Dungan
Principal Investigator
Ohio State University Comprehensive Cancer Center