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

NCT06419816 | Active Not Recruiting

• 1 other identifier: DW_ODNENV_DB_01
• Study Type: observational
• Target: 471
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• change in glycated hemoglobin (HbA1c) levels

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

  24 weeks

Secondary Outcomes (9)

• change in glycated hemoglobin (HbA1c) levels

  6 weeks

• change in glycated hemoglobin (HbA1c) levels

  12 weeks

• change in glycated hemoglobin (HbA1c) levels

  18 weeks

• the change in fasting plasma glucose (FPG)

  6 weeks

• the change in fasting plasma glucose (FPG)

  12 weeks

Study Arms (1)

Patients with type 2 diabetes

mobile application "WellCheck" use

Other: Physician-managed "WellCheck" use; Other: self-managed "WellCheck" use

Interventions

Physician-managed "WellCheck" use OTHER

Physician-managed "WellCheck" use

Patients with type 2 diabetes

self-managed "WellCheck" use OTHER

self-managed "WellCheck" use

Patients with type 2 diabetes

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults aged 19 years and older.
• 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)
• 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.

You may not qualify if:

• Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.).
• 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
• Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60ml/min/1.73m2.
• 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.).
• Pregnant and lactating women.
• Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices.
• Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Kyung Hee University Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40773465 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: June 11, 2024
• Primary Completion: December 31, 2025
• Study Completion: June 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

KR (1)