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

Samsung Medical Center

Status: Not yet enrolling

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

Treatments: Other: Individualized automatic coaching message for glycemic management and depressive symptom

Study type: Interventional

Funder types: Other

Identifiers

NCT06769906

SamsungMC_ENDO_3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Individualized automatic coaching message for glycemic management and depressive symptoms

Experimental group

Description:

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.

Treatment:

Other: Individualized automatic coaching message for glycemic management and depressive symptom

Control

No Intervention group

Description:

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).