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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time In Range | Derived from continuous glucose monitoring (CGM) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Albuminuria | Urine creatinine-to-albumin ratio | Week 12 |
| Level of Glycated albumin | Glycated albumin | Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GYURI KIM | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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1:1 ratio
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| 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 |
| Time In Tight Range | Derived from CGM | Week 12 |
| Level of glycated Hemoglobin | Derived from blood measurement | 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 |
| Level of triglycerides | Level of triglycerides from blood measurement | Week 12 |
| Level of total cholesterol | Level of total cholesterol 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003863 | Depression |
| D001526 | Behavioral Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
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