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

NCT ID: NCT06769906

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2025-07-02

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.

Conditions

Diabetes Mellitus Type 2; Continuous Glucose Measurement; Depressive Symptom

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Individualized automatic coaching message for glycemic management and depressive symptom

Intervention Type: OTHER

For 12 weeks, the intervention group will apply continuous glucose monitoring system and 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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individualized automatic coaching message for glycemic management and depressive symptom

For 12 weeks, the intervention group will apply continuous glucose monitoring system and 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gyuri Kim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GYURI KIM

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SamsungMC_ENDO_3

Identifier Type: -

Identifier Source: org_study_id