Effectiveness of Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus Type 2; Continuous Glucose Measurement; Depressive Symptom

• Registration Number: NCT06769906
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study Start: 2025-01-09
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time In Range	Week 12	Derived from continuous glucose monitoring (CGM)

Secondary Outcome Measures

Name	Time	Method
Time Below Range	Week 12	Derived from CGM
Coefficient of Variation	Week 12	Derived from CGM
Glycemic Management Indicator	Week 12	Derived from CGM
Depressive symptoms	Week 12	Patient Health Questionnaire-9 (PHQ-9); Minimum and Maximum Values: The PHQ-9 consists of nine items, each scored from 0 (not at all) to 3 (nearly every day). The scores for each item are summed to give a total score, resulting in a range from 0 to 27.; Higher Scores: Higher scores on the PHQ-9 indicate worse outcomes, meaning greater severity of depressive symptoms. Lower scores suggest fewer symptoms of depression or none at all.; Interpretation of Scores: 0-4: Minimal or no depression; 5-9: Mild depression; 10-19: Moderate depression; 20-27: Severe depression
Diabetes treatment satisfaction	Week 12	Diabetes Treatment Satisfaction Questionnaire (DTSQ); Minimum and Maximum Values: The DTSQ consists of eight items, with six items measuring satisfaction scored on a 0-6 scale (where 0 is very dissatisfied and 6 is very satisfied). The scores for these six items are summed, giving a total score range from 0 to 36.; Higher Scores: Higher scores on the DTSQ indicate better satisfaction with diabetes treatment. A higher total score suggests greater satisfaction, while a lower score indicates dissatisfaction.
Time In Tight Range	Week 12	Derived from CGM
Level of glycated Hemoglobin	Week 12	Derived from blood measurement
Time Above Range	Week 12	Derived from CGM

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of