Efficacy of Individualized Automatic Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 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, confirmatory study of efficacy of individualized automatic coaching message for glycemic management and depressive symptom in patients with type 1 diabetes. The study will enroll patients with type 1 diabetes who are applying continuous glucose monitoring (CGM) and receiving twice-monthly non-face-to-face management by a dedicated education nurse through the Type 1 Diabetes Home Care Project and Educational Consultation program. For 12 weeks, 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 depression symptoms based on depression questionnaires, instead of non-face-to-face diabetes management. The control group will continue their current treatment and non-face-to-face diabetes management. The aim of this study is to evaluate whether the efficacy of automated, personalized coaching messages for glycemic management and depressive symptoms is non-inferior to the current non-face-to-face management approach 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes, age 18-75 years old
- •Patients who have used continuous glucose monitoring at least three months and have enrolled in Type 1 Diabetes Home Care Project and Educational Consultation program.
- •Patients with at least 70% of 14 days of continuous glucose monitor data within the past month
- •Glycated hemoglobin 7% or higher, or Glycated hemoglobin 6% or higher but less than 7% and failing to meet 1 of the continuous glucose monitor blood glucose target values: time in range (70-180 mg/L) 70% or less, or time below range (<70 mg/L) 4% or more, or time above range (>180 mg/L) 25% or more, or glucose management indicator (GMI) 7% or more, or coefficient of variation (CV%) 36% or more.
- •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
- •Steroid and immunosuppressant users. But it can be included if patients continuously maintain same drug dose at least three months.
- •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
Current Treatment
The study will enroll patients with type 1 diabetes who are already receiving twice-monthly non-face-to-face management by a dedicated education nurse through the Type 1 Diabetes Home Care Project and Educational Consultation program. The control group will continue their current treatment and non-face-to-face diabetes management.
Individualized automatic coaching message for glycemic management and depressive symptoms
The study will enroll patients with type 1 diabetes who are already receiving twice-monthly non-face-to-face management by a dedicated education nurse through the Type 1 Diabetes Home Care Project and Educational Consultation program. For 12 weeks, 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 depression symptoms based on depression questionnaires, instead of non-face-to-face diabetes management.
干预措施: individualized automatic coaching message for glycemic management and depressive symptom (Other)
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
- 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)
- Coefficient of Variation(Week 12)
- Glycemic Management Indicator(Week 12)
研究者
Gyuri Kim
Principal Investigator
Samsung Medical Center