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Type 2 DiabetesNCT06419816

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

An observational study of Type 2 Diabetes, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Physician-managed "WellCheck" use and self-managed "WellCheck" use
How many people
471 participants
Where
1 siteSouth Korea
Study dates
11 Jun 2024to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyung Hee University Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Type 2 Diabetes
Being tested
Physician-managed "WellCheck" use, self-managed "WellCheck" use
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physician-managed "WellCheck" useOther

    Physician-managed "WellCheck" use

  • self-managed "WellCheck" useOther

    self-managed "WellCheck" use

Study groups in NCT06419816
Study groupRoleWhat they receive
Patients with type 2 diabetesmobile application "WellCheck" use
Receives: Other: Physician-managed "WellCheck" use; Other: self-managed "WellCheck" use

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in glycated hemoglobin (HbA1c) levels

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

    Measured: 24 weeks

Secondary outcomes (9)

  1. change in glycated hemoglobin (HbA1c) levels

    change in glycated hemoglobin (HbA1c) levels at 6 weeks post-baseline

    Measured: 6 weeks

  2. change in glycated hemoglobin (HbA1c) levels

    change in glycated hemoglobin (HbA1c) levels at 12 weeks post-baseline

    Measured: 12 weeks

  3. change in glycated hemoglobin (HbA1c) levels

    change in glycated hemoglobin (HbA1c) levels at 18 weeks post-baseline

    Measured: 18 weeks

  4. the change in fasting plasma glucose (FPG)

    the change in fasting plasma glucose (FPG) at 6 weeks post-baseline

    Measured: 6 weeks

  5. the change in fasting plasma glucose (FPG)

    the change in fasting plasma glucose (FPG) at 12 weeks post-baseline

    Measured: 12 weeks

  6. the change in fasting plasma glucose (FPG)

    the change in fasting plasma glucose (FPG) at 18 weeks post-baseline

    Measured: 18 weeks

  7. 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

    Measured: 6 weeks

  8. 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

    Measured: 12 weeks

  9. 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

    Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2024
  2. Study start11 Jun 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06419816
Sponsor's protocol ID
DW_ODNENV_DB_01
Status last verified
Aug 2025
First submitted
14 May 2024
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 40773465

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in glycated hemoglobin (HbA1c) levels (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06419816, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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