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NCT Number: NCT06684678

Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Behavior Behavioral Symptoms Continuous Glucose Measurement Depression Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Location contact

Gyuri Kim, M.D., PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. Time In Range

    Time frame: Week 12

    Derived from continuous glucose monitoring (CGM)

Secondary outcomes

  1. Diabetes treatment satisfaction

    Time frame: Week 12

    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.

  2. Depressive symptoms

    Time frame: Week 12

    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

  3. Time In Tight Range

    Time frame: Week 12

    Derived from CGM

  4. Level of Glycated Hemoglobin

    Time frame: Week 12

    Derived from blood measurement

  5. Time Above Range

    Time frame: Week 12

    Derived from CGM

  6. Time Below Range

    Time frame: Week 12

    Derived from CGM

  7. Coefficient of Variation

    Time frame: Week 12

    Derived from CGM

  8. Glycemic Management Indicator

    Time frame: Week 12

    Derived from CGM

Other outcomes

  1. Level of Albuminuria

    Time frame: Week 12

    Urine creatinine-to-albumin ratio

  2. Level of Glycated albumin

    Time frame: Week 12

    Glycated albumin

  3. Level of total cholesterol

    Time frame: Week 12

    total cholesterol from blood measurement

  4. Level of triglycerides

    Time frame: Week 12

    Level of triglycerides from blood measurement

  5. Level of HDL (high density lipoprotein) cholesterol

    Time frame: Week 12

    Level of HDL cholesterol from blood measurement

  6. Level of LDL (low density lipoprotein) cholesterol

    Time frame: Week 12

    Level of LDL cholesterol from blood measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Kim

CONTACT

[email protected]

82-3410-0859

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 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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