Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSamsung Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- individualized automatic coaching message for glycemic management and depressive symptom
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov