Feasibility and Acceptability of Individualized Automatic Target Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Time In Range
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Personalized coaching messages for glycemic management and depressive symptoms
Intervention: Personalized coaching messages for blood glucose and emotions (Behavioral)
Treatment as usual
Outcomes
Primary Outcomes
Time In Range
Time Frame: Week 6
Derived from CGM
Secondary Outcomes
- 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)
Investigators
Gyuri Kim
Samsung Medical Centor
Samsung Medical Center