Feasibility and Acceptability of Individualized Automatic Target Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Time In Range
研究概览
简要总结
This is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. The control group will remain on their current treatment and will not receive any intervention. The purpose of this trial is to evaluate the feasibility and acceptability of the clinical application of automated, personalized coaching messages for glycemic management and depressive symptom in people with type 1 diabetes.
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
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are determined to use continuous glucose monitoring based on their physician's medical judgment.
- •Patients with type 1 diabetes, age 20-69 years old
- •Currently receiving treatment with multiple insulin injection therapy
- •Patients who have access to KakaoTalk via smartphone and are able to communicate with it
- •Voluntarily agreed to participate in this clinical study.
排除标准
- •Subjects using oral hypoglycemic agents
- •Steroid and immunosuppressant users
- •Subjects receiving anticancer medications
- •Breastfeeding or pregnant patients
- •Patients who do not voluntarily consent to the study
- •Anyone deemed unsuitable by the investigator to participate in the study
研究组 & 干预措施
Personalized coaching messages for glycemic management and depressive symptoms
干预措施: Personalized coaching messages for blood glucose and emotions (Behavioral)
Treatment as usual
结局指标
主要结局
Time In Range
时间窗: Week 6
Derived from CGM
次要结局
- Time Below Range(Week 6)
- Diabetes treatment satisfaction(Week 6)
- Time In Tight Range(Week 6)
- Glycemic Management Indicator(Week 6)
- Depressive symptoms(Week 6)
- Time Above Range(Week 6)
- Coefficient of Variation(Week 6)
研究者
Gyuri Kim
Samsung Medical Centor
Samsung Medical Center