Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom

NCT ID: NCT06684678

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-13
• Study Completion Date: 2025-04-30

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.

Conditions

Diabetes Mellitus, Type 1; Continuous Glucose Measurement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Individualized automatic coaching message for glycemic management and depressive symptoms

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.

Group Type: EXPERIMENTAL

individualized automatic coaching message for glycemic management and depressive symptom

Intervention Type: OTHER

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.

Current Treatment

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

individualized automatic coaching message for glycemic management and depressive symptom

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gyuri Kim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Central Contacts

Kim

Role: CONTACT

gyuri5.kim@samsung.com

82-3410-0859

Facility Contacts

Gyuri Kim, M.D., PhD

Role: primary

gyuri5.kim@samsung.com

Other Identifiers

SMO124027

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024F-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RS-2024-00399025

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SamsungMC_ENDO_2

Identifier Type: -

Identifier Source: org_study_id