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

NCT06769906 | Completed

• 1 other identifier: SamsungMC_ENDO_3
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Continuous Glucose Measurement; Diabetes Mellitus Type 2; Depressive Symptom

Keywords

Behavioral Symptom; Glucose Metabolism Disorders; Endocrine System Diseases; Diabetes Mellitus, Type 2; Continuous glucose monitoring; Depression; Diabetes Mellitus; Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Time In Range

  Derived from continuous glucose monitoring (CGM)

  Week 12

Secondary Outcomes (8)

• Diabetes treatment satisfaction

  Week 12

• Depressive symptoms

  Week 12

• Time In Tight Range

  Week 12

• Level of glycated Hemoglobin

  Week 12

• Time Above Range

  Week 12

Other Outcomes (6)

• Level of Albuminuria

  Week 12

• Level of Glycated albumin

  Week 12

• Level of triglycerides

  Week 12

Study Arms (2)

Individualized automatic coaching message for glycemic management and depressive symptoms

EXPERIMENTAL

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

Control

NO INTERVENTION

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).

Interventions

Individualized automatic coaching message for glycemic management and depressive symptom 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.

Individualized automatic coaching message for glycemic management and depressive symptoms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression; Behavioral Symptoms; Glucose Metabolism Disorders; Endocrine System Diseases; Diabetes Mellitus; Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Behavior

Study Officials

• GYURI KIM

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1 ratio

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 9, 2025
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)