Clinical trial NCT06684678: Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom
Official title: Efficacy of Individualized Automatic Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Continuous Glucose Measurement
Keywords: type 1 diabetes
continuous glucose monitoring
depressive symptom
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 ratio
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time In Range
timeFrame: Week 12
Secondary outcomes:
measure: Diabetes treatment satisfaction
timeFrame: Week 12
measure: Depressive symptoms
timeFrame: Week 12
measure: Time In Tight Range
timeFrame: Week 12
measure: Level of Glycated Hemoglobin
timeFrame: Week 12
measure: Time Above Range
timeFrame: Week 12
measure: Time Below Range
timeFrame: Week 12
measure: Coefficient of Variation
timeFrame: Week 12
measure: Glycemic Management Indicator
timeFrame: Week 12
Other outcomes:
measure: Level of Albuminuria
timeFrame: Week 12
measure: Level of Glycated albumin
timeFrame: Week 12
measure: Level of total cholesterol
timeFrame: Week 12
measure: Level of triglycerides
timeFrame: Week 12
measure: Level of HDL (high density lipoprotein) cholesterol
timeFrame: Week 12
measure: Level of LDL (low density lipoprotein) cholesterol
timeFrame: Week 12
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: