Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom

Efficacy of Individualized Automatic Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom: A Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 1; Continuous Glucose Measurement
• Intervention / Treatment: Other: individualized automatic coaching message for glycemic management and depressive symptom

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim; Phone Number: 82-3410-0859; Email: gyuri5.kim@samsung.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center
    • Contact: Gyuri Kim, M.D., PhD; Email: gyuri5.kim@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time In Range	Derived from continuous glucose monitoring (CGM)	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time In Tight Range	Derived from CGM	Week 12
Time Above Range	Derived from CGM	Week 12
Time Below Range	Derived from CGM	Week 12
Coefficient of Variation	Derived from CGM	Week 12
Glycemic Management Indicator	Derived from CGM	Week 12
Diabetes treatment satisfaction	Diabetes Treatment Satisfaction Questionnaire (DTSQ); Minimum and Maximum Values: The DTSQ consists of eight items, with six items measuring satisfaction scored on a 0-6 scale (where 0 is very dissatisfied and 6 is very satisfied). The scores for these six items are summed, giving a total score range from 0 to 36. Higher Scores: Higher scores on the DTSQ indicate better satisfaction with diabetes treatment. A higher total score suggests greater satisfaction, while a lower score indicates dissatisfaction.	Week 12
Depressive symptoms	Patient Health Questionnaire-9 (PHQ-9); Minimum and Maximum Values: The PHQ-9 consists of nine items, each scored from 0 (not at all) to 3 (nearly every day). The scores for each item are summed to give a total score, resulting in a range from 0 to 27. Higher Scores: Higher scores on the PHQ-9 indicate worse outcomes, meaning greater severity of depressive symptoms. Lower scores suggest fewer symptoms of depression or none at all. Interpretation of Scores: 0-4: Minimal or no depression; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; 20-27: Severe depression	Week 12
Level of Glycated Hemoglobin	Derived from blood measurement	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Albuminuria	Urine creatinine-to-albumin ratio	Week 12
Level of Glycated albumin	Glycated albumin	Week 12
Level of total cholesterol	total cholesterol from blood measurement	Week 12
Level of triglycerides	Level of triglycerides from blood measurement	Week 12
Level of HDL (high density lipoprotein) cholesterol	Level of HDL cholesterol from blood measurement	Week 12
Level of LDL (low density lipoprotein) cholesterol	Level of LDL cholesterol from blood measurement	Week 12

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): November 13, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: November 10, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: type 1 diabetes; continuous glucose monitoring; depressive symptom
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Glucose Metabolism Disorders; Diabetes Mellitus; Depression; Diabetes Mellitus, Type 1
• Other Study ID Numbers: SamsungMC_ENDO_2; SMO124027 (Other Grant/Funding Number: Samsung Medical Center); 2024F-2 (Other Grant/Funding Number: Korean Diabetes Association); RS-2024-00399025 (Other Grant/Funding Number: Korea Health Industry Development Institute (KHIDI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No