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

Launched by DAEWOONG PHARMACEUTICAL CO. LTD. · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the impact of a smartphone app called "WellCheck" on managing Type 2 diabetes. The goal is to see if using this app can help patients better control their blood sugar levels, blood pressure, and weight in real-life healthcare settings. The study is open to adults aged 19 and older who have Type 2 diabetes and are beginning treatment with a specific medication called Enavogliflozin. Participants will need to be comfortable using the app, and they must give their consent to take part in the study.

If you qualify, you can expect to use the WellCheck app as part of your diabetes management, while your healthcare team monitors your health outcomes. This trial is currently recruiting participants, and it’s important to note that not everyone with diabetes will be eligible. For example, individuals with other types of diabetes, certain kidney or liver conditions, or those who are pregnant will not be able to join. If you are considering participation, your doctor will help determine if this study is a good fit for you.

Gender

ALL

Eligibility criteria

• 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.