Effect of Linking Data Using Smartphone Application, 'Well Check', on Clinical Outcomes in Patients With Type 2 Diabetes Mellitus

Active, not recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06419816
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Study Start: 2024-06-11
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-09-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

1. Adults aged 19 years and older.

2. 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:

   • Enavogliflozin monotherapy
   • Combination therapy of Enavogliflozin with two agents (metformin)
   • Combination therapy of Enavogliflozin with three agents (metformin + DPP-4 inhibitor)

3. Individuals who have received detailed explanation and have understood the nature of the observational study and the investigational drug, and have provided written consent to participate voluntarily in the observational study and to comply with subject precautions during the study period.

Exclusion Criteria

1. Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.).

2. Individuals who are contraindicated for Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the approved indications:

   • Patients with a history of hypersensitivity reactions to the components of Enavogliflozin or Enavogliflozin Extended-Release Tablets
   • Patients with an eGFR (estimated Glomerular Filtration Rate) less than 30 mL/min/1.73m2, end-stage renal disease, or undergoing dialysis
   • Patients with moderate to severe hepatic impairment (AST or ALT > 3 times the upper limit of normal, Total Bilirubin > 2 times the upper limit of normal, hepatitis or hepatic failure)
   • Patients classified as NYHA (New York Heart Association) class III or IV

3. Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60ml/min/1.73m2.

4. Patients with unstable weight due to treatment with obesity drugs or weight loss medications within 3 months prior to enrollment or other treatments (surgery, dietary therapy, etc.).

5. Pregnant and lactating women.

6. Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices.

7. Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in glycated hemoglobin (HbA1c) levels	24 weeks	change in glycated hemoglobin (HbA1c) levels at 24 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
change in glycated hemoglobin (HbA1c) levels	18 weeks	change in glycated hemoglobin (HbA1c) levels at 18 weeks post-baseline
the proportion of participants achieving HbA1c less than 7% or 6.5%	18 weeks	the proportion of participants achieving HbA1c less than 7% or 6.5% at 18 weeks post-baseline
the change in fasting plasma glucose (FPG)	18 weeks	the change in fasting plasma glucose (FPG) at 18 weeks post-baseline

Trial Locations

Locations (1)

Kyung Hee University Medical Center; 🇰🇷 Seoul, South Korea