NCT06684678Not yet recruiting
Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom
Efficacy of Individualized Automatic Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 10 Nov 2024
- Start date
- 13 Nov 2024
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Samsung Medical Center
- Diseases
- Type 1 diabetes
- NCT number
- NCT06684678
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 13 Nov 2024 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Steroid and immunosuppressant users. But it can be included if patients continuously maintain same drug dose at least three months.
Other
- Breastfeeding or pregnant patients
- Patients who do not voluntarily consent to the study
- Anyone deemed unsuitable by the investigator to participate in the study
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.