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Completed

NCT Number: NCT06769906

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Time In Range

    Time frame: Week 12

    Derived from continuous glucose monitoring (CGM)

Secondary outcomes

  1. Diabetes treatment satisfaction

    Time frame: 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.

  2. Depressive symptoms

    Time frame: 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

  3. Time In Tight Range

    Time frame: Week 12

    Derived from CGM

  4. Level of glycated Hemoglobin

    Time frame: Week 12

    Derived from blood measurement

  5. Time Above Range

    Time frame: Week 12

    Derived from CGM

  6. Time Below Range

    Time frame: Week 12

    Derived from CGM

  7. Coefficient of Variation

    Time frame: Week 12

    Derived from CGM

  8. Glycemic Management Indicator

    Time frame: Week 12

    Derived from CGM

Other outcomes

  1. Level of Albuminuria

    Time frame: Week 12

    Urine creatinine-to-albumin ratio

  2. Level of Glycated albumin

    Time frame: Week 12

    Glycated albumin

  3. Level of triglycerides

    Time frame: Week 12

    Level of triglycerides from blood measurement

  4. Level of total cholesterol

    Time frame: Week 12

    Level of total cholesterol from blood measurement

  5. Level of HDL (high density lipoprotein) cholesterol

    Time frame: Week 12

    Level of HDL cholesterol from blood measurement

  6. Level of LDL (low density lipoprotein) cholesterol

    Time frame: Week 12

    Level of LDL cholesterol from blood measurement

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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