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

Effectiveness of Individualized Automatic Target Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom in Patients With Insulin-treated Type 2 Diabetes: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2; Continuous Glucose Measurement; Depressive Symptom
• Intervention / Treatment: Other: Individualized automatic coaching message for glycemic management and depressive symptom

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time In Range	Derived from continuous glucose monitoring (CGM)	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time In Tight Range	Derived from CGM	Week 12
Time Above Range	Derived from CGM	Week 12
Time Below Range	Derived from CGM	Week 12
Coefficient of Variation	Derived from CGM	Week 12
Glycemic Management Indicator	Derived from CGM	Week 12
Diabetes treatment satisfaction	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.	Week 12
Depressive symptoms	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	Week 12
Level of glycated Hemoglobin	Derived from blood measurement	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Albuminuria	Urine creatinine-to-albumin ratio	Week 12
Level of Glycated albumin	Glycated albumin	Week 12
Level of triglycerides	Level of triglycerides from blood measurement	Week 12
Level of HDL (high density lipoprotein) cholesterol	Level of HDL cholesterol from blood measurement	Week 12
Level of LDL (low density lipoprotein) cholesterol	Level of LDL cholesterol from blood measurement	Week 12
Level of total cholesterol	Level of total cholesterol from blood measurement	Week 12

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: GYURI KIM, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Actual): July 2, 2025
• Study Completion (Actual): July 2, 2025

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Diabetes Mellitus; Diabetes Mellitus, Type 2; Continuous glucose monitoring; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavioral Symptom
• Additional Relevant MeSH Terms: Behavior; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Depression; Diabetes Mellitus; Behavioral Symptoms; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
• Other Study ID Numbers: SamsungMC_ENDO_3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No