Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom

NCT06684678 | Not Yet Recruiting

• 4 other identifiers: SamsungMC_ENDO_2SMO1240272024F-2RS-2024-00399025
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

type 1 diabetes; continuous glucose monitoring; depressive symptom

Outcome Measures

Primary Outcomes (1)

• Time In Range

  Derived from continuous glucose monitoring (CGM)

  Week 12

Secondary Outcomes (8)

• Diabetes treatment satisfaction

  Week 12

• Depressive symptoms

  Week 12

• Time In Tight Range

  Week 12

• Level of Glycated Hemoglobin

  Week 12

• Time Above Range

  Week 12

Other Outcomes (6)

• Level of Albuminuria

  Week 12

• Level of Glycated albumin

  Week 12

• Level of total cholesterol

  Week 12

Study Arms (2)

Individualized automatic coaching message for glycemic management and depressive symptoms

EXPERIMENTAL

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.

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

Current Treatment

NO INTERVENTION

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.

Interventions

individualized automatic coaching message for glycemic management and depressive symptom 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.

Individualized automatic coaching message for glycemic management and depressive symptoms

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Depression

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Kim

CONTACT

82-3410-0859; gyuri5.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1 ratio

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: November 13, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)