Clinical trial NCT06769906: Effectiveness of Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Continuous Glucose Measurement
Depressive Symptom
Keywords: Behavioral Symptom
Glucose Metabolism Disorders
Endocrine System Diseases
Diabetes Mellitus, Type 2
Continuous glucose monitoring
Depression
Diabetes Mellitus
Metabolic Diseases
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 ratio
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time In Range
timeFrame: Week 12
Secondary outcomes:
measure: Diabetes treatment satisfaction
timeFrame: Week 12
measure: Depressive symptoms
timeFrame: Week 12
measure: Time In Tight Range
timeFrame: Week 12
measure: Level of glycated Hemoglobin
timeFrame: Week 12
measure: Time Above Range
timeFrame: Week 12
measure: Time Below Range
timeFrame: Week 12
measure: Coefficient of Variation
timeFrame: Week 12
measure: Glycemic Management Indicator
timeFrame: Week 12
Other outcomes:
measure: Level of Albuminuria
timeFrame: Week 12
measure: Level of Glycated albumin
timeFrame: Week 12
measure: Level of triglycerides
timeFrame: Week 12
measure: Level of total cholesterol
timeFrame: Week 12
measure: Level of HDL (high density lipoprotein) cholesterol
timeFrame: Week 12
measure: Level of LDL (low density lipoprotein) cholesterol
timeFrame: Week 12
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: GYURI KIM
role: PRINCIPAL_INVESTIGATOR
References: