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Completed

NCT Number: NCT06525454

Individualized Automatic Target Coaching Message for Glycemic Management and Depressive Symptom

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Time In Range

    Time frame: Week 6

    Derived from CGM

Secondary outcomes

  1. Diabetes treatment satisfaction

    Time frame: Week 6

    DSTQ

  2. Depressive symptoms

    Time frame: Week 6

    PHQ-9

  3. Time In Tight Range

    Time frame: Week 6

    Derived from CGM

  4. Time Above Range

    Time frame: Week 6

    Derived from CGM

  5. Time Below Range

    Time frame: Week 6

    Derived from CGM

  6. Coefficient of Variation

    Time frame: Week 6

    Derived from CGM

  7. Glycemic Management Indicator

    Time frame: Week 6

    Derived from CGM

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Feasibility and Acceptability of Individualized Automatic Target Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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