An observational study in Type 2 Diabetes, sponsored by Daewoong Pharmaceutical Co. LTD.. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Daewoong Pharmaceutical Co. LTD. · Observational
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 471 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
According to the calculation using G*Power 3.1.9.7, the required sample size for conducting this study is determined to be 11,698 individuals. Considering an approximate dropout rate of 30%, recruitment of around 15,000 participants is planned.
Patients with Type 2 diabetes who are scheduled to receive initial treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the attending physician's medical judgment, within the following insurance coverage ranges:
Exclusion Criteria:
Individuals who are contraindicated for Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the approved indications:
mobile application "WellCheck" use
Other: Physician-managed "WellCheck" use · Other: self-managed "WellCheck" use
Physician-managed "WellCheck" use
self-managed "WellCheck" use
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
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
Plan to share: Undecided
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Daewoong Pharmaceutical Co. LTD.