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Individualized Automatic Target Coaching Message for Glycemic Management and Depressive Symptom

Not Applicable
Completed
Conditions
Diabetes Mellitus, Type 1
Interventions
Behavioral: Personalized coaching messages for blood glucose and emotions
Registration Number
NCT06525454
Lead Sponsor
Samsung Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Personalized coaching messages for glycemic management and depressive symptomsPersonalized coaching messages for blood glucose and emotions-
Primary Outcome Measures
NameTimeMethod
Time In RangeWeek 6

Derived from CGM

Secondary Outcome Measures
NameTimeMethod
Time Below RangeWeek 6

Derived from CGM

Diabetes treatment satisfactionWeek 6

DSTQ

Time In Tight RangeWeek 6

Derived from CGM

Glycemic Management IndicatorWeek 6

Derived from CGM

Depressive symptomsWeek 6

PHQ-9

Time Above RangeWeek 6

Derived from CGM

Coefficient of VariationWeek 6

Derived from CGM

Trial Locations

Locations (1)

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

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