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Diabetes Mellitus Type 2NCT06769906

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

A study testing Individualized automatic coaching message for glycemic management and depressive symptom in people with Diabetes Mellitus Type 2 and Continuous Glucose Measurement, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Individualized automatic coaching message for glycemic management and depressive symptom
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteSouth Korea
Study dates
9 Jan 2025to 2 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official 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

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.

Read the 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.

Being tested
Individualized automatic coaching message for glycemic management and depressive symptom
Keywords
Behavioral Symptom, Glucose Metabolism Disorders, Endocrine System Diseases, Diabetes Mellitus, Type 2, Continuous glucose monitoring, Depression, Diabetes Mellitus, Metabolic Diseases
Medical subject headings
Diabetes Mellitus, Type 2, Depression, Behavioral Symptoms, Glucose Metabolism Disorders, Endocrine System Diseases, Diabetes Mellitus, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized automatic coaching message for glycemic management and depressive symptomOther

    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.

Study groups in NCT06769906
Study groupRoleWhat they receive
Individualized automatic coaching message for glycemic management and depressive symptomsExperimentalThe 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.
Receives: Other: Individualized automatic coaching message for glycemic management and depressive symptom
ControlNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Time In Range

    Derived from continuous glucose monitoring (CGM)

    Measured: Week 12

Secondary outcomes (8)

  1. 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.

    Measured: Week 12

  2. 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

    Measured: Week 12

  3. Time In Tight Range

    Derived from CGM

    Measured: Week 12

  4. Level of glycated Hemoglobin

    Derived from blood measurement

    Measured: Week 12

  5. Time Above Range

    Derived from CGM

    Measured: Week 12

  6. Time Below Range

    Derived from CGM

    Measured: Week 12

  7. Coefficient of Variation

    Derived from CGM

    Measured: Week 12

  8. Glycemic Management Indicator

    Derived from CGM

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start9 Jan 2025
  3. Primary completion2 Jul 2025
  4. Study completion2 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 ratio
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06769906
Sponsor's protocol ID
SamsungMC_ENDO_3
Status last verified
Dec 2025
First submitted
6 Jan 2025
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Individualized automatic coaching message for glycemic management and depressive symptom in people with Diabetes Mellitus Type 2 and Continuous Glucose Measurement, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time In Range (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06769906.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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