Continuous Glucose Measurement, Depressive Symptom, Diabetes Mellitus Type 2
Conditions
Keywords
Behavioral Symptom, Glucose Metabolism Disorders, Endocrine System Diseases, Diabetes Mellitus, Type 2, Continuous glucose monitoring, Depression, Diabetes Mellitus, Metabolic Diseases
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.
Interventions
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.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time In Range | Week 12 | Derived from continuous glucose monitoring (CGM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | 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 |
| Time In Tight Range | Week 12 | Derived from CGM |
| Level of glycated Hemoglobin | Week 12 | Derived from blood measurement |
| Time Above Range | Week 12 | Derived from CGM |
| Time Below Range | Week 12 | Derived from CGM |
| Coefficient of Variation | Week 12 | Derived from CGM |
| Glycemic Management Indicator | Week 12 | Derived from CGM |
| Diabetes treatment satisfaction | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Level of triglycerides | Week 12 | Level of triglycerides from blood measurement |
| Level of total cholesterol | Week 12 | Level of total cholesterol from blood measurement |
| Level of HDL (high density lipoprotein) cholesterol | Week 12 | Level of HDL cholesterol from blood measurement |
| Level of LDL (low density lipoprotein) cholesterol | Week 12 | Level of LDL cholesterol from blood measurement |
| Level of Glycated albumin | Week 12 | Glycated albumin |
| Level of Albuminuria | Week 12 | Urine creatinine-to-albumin ratio |
Countries
South Korea
Outcome results
None listed