Samsung Medical Center
Seoul, South Korea
NCT Number: NCT06769906
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Week 12
Derived from continuous glucose monitoring (CGM)
Time frame: 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.
Time frame: 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 frame: Week 12
Derived from CGM
Time frame: Week 12
Derived from blood measurement
Time frame: Week 12
Derived from CGM
Time frame: Week 12
Derived from CGM
Time frame: Week 12
Derived from CGM
Time frame: Week 12
Derived from CGM
Time frame: Week 12
Urine creatinine-to-albumin ratio
Time frame: Week 12
Glycated albumin
Time frame: Week 12
Level of triglycerides from blood measurement
Time frame: Week 12
Level of total cholesterol from blood measurement
Time frame: Week 12
Level of HDL cholesterol from blood measurement
Time frame: Week 12
Level of LDL cholesterol from blood measurement
Samsung Medical Center
Other
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
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