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| ID | Type | Description | Link |
|---|---|---|---|
| SMO124027 | Other Grant/Funding Number | Samsung Medical Center | |
| 2024F-2 | Other Grant/Funding Number | Korean Diabetes Association | |
| RS-2024-00399025 | Other Grant/Funding Number | Korea Health Industry Development Institute (KHIDI) |
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This is a single-center, randomized, prospective, confirmatory study of efficacy of individualized automatic coaching message for glycemic management and depressive symptom in patients with type 1 diabetes. The study will enroll patients with type 1 diabetes who are applying continuous glucose monitoring (CGM) and receiving twice-monthly non-face-to-face management by a dedicated education nurse through the Type 1 Diabetes Home Care Project and Educational Consultation program. For 12 weeks, 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 depression symptoms based on depression questionnaires, instead of non-face-to-face diabetes management. The control group will continue their current treatment and non-face-to-face diabetes management. The aim of this study is to evaluate whether the efficacy of automated, personalized coaching messages for glycemic management and depressive symptoms is non-inferior to the current non-face-to-face management approach in people with type 1 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 patients with type 1 diabetes who are already receiving twice-monthly non-face-to-face management by a dedicated education nurse through the Type 1 Diabetes Home Care Project and Educational Consultation program. For 12 weeks, 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 depression symptoms based on depression questionnaires, instead of non-face-to-face diabetes management. |
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| Current Treatment | No Intervention | The study will enroll patients with type 1 diabetes who are already receiving twice-monthly non-face-to-face management by a dedicated education nurse through the Type 1 Diabetes Home Care Project and Educational Consultation program. The control group will continue their current treatment and non-face-to-face diabetes management. |
| 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 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, instead of non-face-to-face diabetes management. |
| 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Kim | Contact | 82-3410-0859 | gyuri5.kim@samsung.com |
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| 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; 10-14: Moderate depression; 15-19: Moderately severe 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 total cholesterol | total cholesterol from blood measurement | Week 12 |
| Level of triglycerides | Level of triglycerides 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 |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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