Individualized Automatic Target Coaching Message for Glycemic Management and Depressive Symptom

NCT06525454 | Completed

• 1 other identifier: 2024-06-077
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. The control group will remain on their current treatment and will not receive any intervention. The purpose of this trial is to evaluate the feasibility and acceptability of the clinical application of automated, personalized coaching messages for glycemic management and depressive symptom in people with type 1 diabetes.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Time In Range

  Derived from CGM

  Week 6

Secondary Outcomes (7)

• Diabetes treatment satisfaction

  Week 6

• Depressive symptoms

  Week 6

• Time In Tight Range

  Week 6

• Time Above Range

  Week 6

• Time Below Range

  Week 6

Study Arms (2)

Personalized coaching messages for glycemic management and depressive symptoms

EXPERIMENTAL

Behavioral: Personalized coaching messages for blood glucose and emotions

Treatment as usual

NO INTERVENTION

Interventions

Personalized coaching messages for blood glucose and emotions BEHAVIORAL

For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires.

Personalized coaching messages for glycemic management and depressive symptoms

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are determined to use continuous glucose monitoring based on their physician's medical judgment.
• Patients with type 1 diabetes, age 20-69 years old
• 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:

• Subjects using oral hypoglycemic agents
• Steroid and immunosuppressant users
• Subjects receiving anticancer medications
• 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

Interventions

Blood Glucose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

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: Samsung Medical Centor

Model Details: 1:2 ratio

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 7, 2024
• Primary Completion: September 18, 2024
• Study Completion: September 30, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)