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

A Primary Care-Based, Prospective, Multicenter, Cluster-Randomized, Pragmatic Clinical Trials to Determine the Effect of Linking Data With Investigators When Using the Electronic Health Record-Linked Smartphone Application, 'Well Check', on Clinical Outcomes in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Physician-managed "WellCheck" use; Other: self-managed "WellCheck" use

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 Type: Observational
• Enrollment (Actual): 471

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Kyung Hee University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with type 2 diabetes; mobile application "WellCheck" use	Other: Physician-managed "WellCheck" use; Physician-managed "WellCheck" use; Other: self-managed "WellCheck" use; self-managed "WellCheck" use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in glycated hemoglobin (HbA1c) levels	change in glycated hemoglobin (HbA1c) levels at 24 weeks from baseline	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in glycated hemoglobin (HbA1c) levels	change in glycated hemoglobin (HbA1c) levels at 6 weeks post-baseline	6 weeks
change in glycated hemoglobin (HbA1c) levels	change in glycated hemoglobin (HbA1c) levels at 12 weeks post-baseline	12 weeks
change in glycated hemoglobin (HbA1c) levels	change in glycated hemoglobin (HbA1c) levels at 18 weeks post-baseline	18 weeks
the change in fasting plasma glucose (FPG)	the change in fasting plasma glucose (FPG) at 6 weeks post-baseline	6 weeks
the change in fasting plasma glucose (FPG)	the change in fasting plasma glucose (FPG) at 12 weeks post-baseline	12 weeks
the change in fasting plasma glucose (FPG)	the change in fasting plasma glucose (FPG) at 18 weeks post-baseline	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	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	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	18 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Publications and helpful links

General Publications

• Sang H, Kim S, Hwang J, Woo S, Hwang Y, Kim J, Lee S, Yon DK, Rhee SY. Impact of the WellCheck smartphone app linked to electronic health records on clinical outcomes in patients with type 2 diabetes: Study protocol for primary care-based, prospective, multicenter, cluster-randomized, pragmatic clinical trials. PLoS One. 2025 Aug 7;20(8):e0329003. doi: 10.1371/journal.pone.0329003. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DW_ODNENV_DB_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No