This clinical study aims to evaluate the effects of using the "WellCheck" mobile application on blood glucose, blood pressure, and weight among Type 2 diabetes patients in real primary care settings. It is a prospective, multi-center, cluster-randomized, pragmatic clinical trial. Patients who can use the digital healthcare mobile application without difficulty are recruited based on the clinical judgment of the attending physician.
The study employs a 1:1 cluster-randomized allocation to differentiate between intervention (physician-managed "WellCheck" use) and control groups (self-managed "WellCheck" use) within primary care facilities where intervention and control groups are treated separately. Data collection includes demographic information, physical measurements, vital signs, laboratory tests, and safety evaluations for up to 24 weeks following the initiation of "WellCheck" use. While data collection aligns with routine clinical practice, additional follow-up visits are scheduled at 6, 12, 18, and 24 weeks post-baseline for efficacy and safety assessments. Researchers will collect necessary data based on routine clinical records and "WellCheck" data.
Study Type
OBSERVATIONAL
Enrollment
471
Physician-managed "WellCheck" use
self-managed "WellCheck" use
Kyung Hee University Medical Center
Seoul, South Korea
change in glycated hemoglobin (HbA1c) levels
change in glycated hemoglobin (HbA1c) levels at 24 weeks from baseline
Time frame: 24 weeks
change in glycated hemoglobin (HbA1c) levels
change in glycated hemoglobin (HbA1c) levels at 6 weeks post-baseline
Time frame: 6 weeks
change in glycated hemoglobin (HbA1c) levels
change in glycated hemoglobin (HbA1c) levels at 12 weeks post-baseline
Time frame: 12 weeks
change in glycated hemoglobin (HbA1c) levels
change in glycated hemoglobin (HbA1c) levels at 18 weeks post-baseline
Time frame: 18 weeks
the change in fasting plasma glucose (FPG)
the change in fasting plasma glucose (FPG) at 6 weeks post-baseline
Time frame: 6 weeks
the change in fasting plasma glucose (FPG)
the change in fasting plasma glucose (FPG) at 12 weeks post-baseline
Time frame: 12 weeks
the change in fasting plasma glucose (FPG)
the change in fasting plasma glucose (FPG) at 18 weeks post-baseline
Time frame: 18 weeks
the proportion of participants achieving HbA1c less than 7% or 6.5%
the proportion of participants achieving HbA1c less than 7% or 6.5% at 6 weeks post-baseline
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Time frame: 6 weeks
the proportion of participants achieving HbA1c less than 7% or 6.5%
the proportion of participants achieving HbA1c less than 7% or 6.5% at 12 weeks post-baseline
Time frame: 12 weeks
the proportion of participants achieving HbA1c less than 7% or 6.5%
the proportion of participants achieving HbA1c less than 7% or 6.5% at 18 weeks post-baseline
Time frame: 18 weeks