Continuous Glucose Measurement, Diabetes Mellitus, Type 1
Conditions
Keywords
type 1 diabetes, continuous glucose monitoring, depressive symptom
Brief summary
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.
Interventions
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.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with type 1 diabetes, age 18-75 years old * Patients who have used continuous glucose monitoring at least three months and have enrolled in Type 1 Diabetes Home Care Project and Educational Consultation program. * Patients with at least 70% of 14 days of continuous glucose monitor data within the past month * Glycated hemoglobin 7% or higher, or Glycated hemoglobin 6% or higher but less than 7% and failing to meet 1 of the continuous glucose monitor blood glucose target values: time in range (70-180 mg/L) 70% or less, or time below range (\<70 mg/L) 4% or more, or time above range (\>180 mg/L) 25% or more, or glucose management indicator (GMI) 7% or more, or coefficient of variation (CV%) 36% or more. * 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
* Steroid and immunosuppressant users. But it can be included if patients continuously maintain same drug dose at least three months. * 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; 10-14: Moderate depression; 15-19: Moderately severe 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 total cholesterol | Week 12 | total cholesterol from blood measurement |
| Level of triglycerides | Week 12 | Level of triglycerides 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
Contacts
Primary ContactKim
Outcome results
None listed