Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom

Samsung Medical Center

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type 1; Continuous Glucose Measurement

Treatments: Other: individualized automatic coaching message for glycemic management and depressive symptom

Study type: Interventional

Funder types: Other

Identifiers

NCT06684678

RS-2024-00399025 (Other Grant/Funding Number)

2024F-2 (Other Grant/Funding Number)

SMO124027 (Other Grant/Funding Number)

SamsungMC_ENDO_2

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Individualized automatic coaching message for glycemic management and depressive symptoms

Experimental group

Description:

The study will enroll patients with type 1 diabetes who are already 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.

Treatment:

Other: individualized automatic coaching message for glycemic management and depressive symptom

Current Treatment

No Intervention group

Description:

The study will enroll patients with type 1 diabetes who are already 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. The control group will continue their current treatment and non-face-to-face diabetes management.