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NCT06419816Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
471 (actual)
First submitted
14 May 2024
Start date
11 Jun 2024
Primary completion date
31 Dec 2025
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
NCT number
NCT06419816

What you commit to

  • Study type: Observational
  • Participants enrolled: 471
  • From 11 Jun 2024 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

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

Lab values

  • 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.

Other

  • Pregnant and lactating women.
  • Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.

Who the study is looking for

  • 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.

Age in the registry: 19 years to 80 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Kyung Hee University Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.