Effectiveness of Individualized Automatic Target Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom in Patients With Insulin-treated Type 2 Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Time In Range
研究概览
简要总结
This is a 12-week, single-center, randomized, prospective, confirmatory study of effectiveness of the individualized automatic coaching messages for glycemic management based on continuous glucose monitoring and depressive symptom in insulin-treated patients with type 2 diabetes.
详细描述
This study will enroll patients with type 2 diabetes who are insulin-treated outpatient care at the Department of Endocrinology and Metabolism, Samsung Medical Center. For 12 weeks, both intervention and control groups will apply continuous glucose monitoring system. The intervention group will receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depressive symptoms based on depression questionnaires. The control group will not receive the coaching messages. The aim of this study is to evaluate whether the efficacy of individualized automatic target coaching messages based on continuous glucose monitoring metrics and depressive symptom assessments is superior to those who do not receive the messages in insulin-treated patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for whom the use of a continuous glucose monitor has been determined based on the medical judgment of the attending physician.
- •Insulin-treated type 2 diabetes patients, age 18-80 years old.
- •Patients who have not changed their diabetes medication in the past 2 months.
- •Patients with a glycated hemoglobin level between 6.5% and 12.0% within the last 3 months.
- •Patients currently receiving insulin injection therapy, including basal insulin.
- •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
- •Steroid and immunosuppressant users. But it can be included if patients continuously maintain same drug dose at least three months.
- •Patients who are currently taking weight control 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
Individualized automatic coaching message for glycemic management and depressive symptoms
The study will enroll insulin-treated patients with type 2 diabetes who are already receiving standard care and diabetes management through outpatient visits. For 12 weeks, the intervention group and control will apply continuous glucose monitoring. The intervention group will receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depressive symptoms based on depression questionnaires for 12 weeks.
干预措施: Individualized automatic coaching message for glycemic management and depressive symptom (Other)
Control
The control group will continue their existing treatment and wear a continuous glucose monitoring device, responding to both surveys by accessing the survey link sent to their cell phone. This will allow for the assessment of baseline satisfaction (DTSQ) and depressive symptoms (PHQ-9).
结局指标
主要结局
Time In Range
时间窗: Week 12
Derived from continuous glucose monitoring (CGM)
次要结局
- Coefficient of Variation(Week 12)
- Glycemic Management Indicator(Week 12)
- Diabetes treatment satisfaction(Week 12)
- Depressive symptoms(Week 12)
- Time In Tight Range(Week 12)
- Level of glycated Hemoglobin(Week 12)
- Time Above Range(Week 12)
- Time Below Range(Week 12)
研究者
Gyuri Kim
Principal Investigator
Samsung Medical Center