Diabetes Mellitus, Type 1
Conditions
Brief summary
This is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. The control group will remain on their current treatment and will not receive any intervention. The purpose of this trial is to evaluate the feasibility and acceptability of the clinical application of automated, personalized coaching messages for glycemic management and depressive symptom in people with type 1 diabetes.
Interventions
BEHAVIORALPersonalized coaching messages for blood glucose and emotions
For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
1:2 ratio
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are determined to use continuous glucose monitoring based on their physician's medical judgment. * Patients with type 1 diabetes, age 20-69 years old * Currently receiving treatment with multiple insulin injection therapy * 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
* Subjects using oral hypoglycemic agents * Steroid and immunosuppressant users * Subjects receiving anticancer 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 6 | Derived from CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | Week 6 | PHQ-9 |
| Time In Tight Range | Week 6 | Derived from CGM |
| Time Above Range | Week 6 | Derived from CGM |
| Diabetes treatment satisfaction | Week 6 | DSTQ |
| Coefficient of Variation | Week 6 | Derived from CGM |
| Glycemic Management Indicator | Week 6 | Derived from CGM |
| Time Below Range | Week 6 | Derived from CGM |
Countries
South Korea
Outcome results
None listed