Using a smartphone app to improve health outcomes in Type 2 diabetes patients
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 study is testing whether using a smartphone app called 'WellCheck' can help people with Type 2 diabetes better manage their blood sugar, blood pressure, and weight.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 480 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06419816 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the impact of the 'WellCheck' mobile application on managing blood glucose, blood pressure, and weight in patients with Type 2 diabetes in real-world primary care settings. It employs a prospective, multi-center, cluster-randomized design, where participants are divided into intervention and control groups based on whether their use of the app is physician-managed or self-managed. Data will be collected over 24 weeks, including demographic information, physical measurements, vital signs, and laboratory tests, with follow-up visits scheduled to assess efficacy and safety. The study aims to integrate digital health solutions into routine clinical practice for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with Type 2 diabetes who are starting treatment with Enavogliflozin.
Not a fit: Patients with diabetes types other than Type 2 or those contraindicated for Enavogliflozin may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of Type 2 diabetes and better overall health outcomes for patients.
How similar studies have performed: Other studies have shown promise in using digital health applications for chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Kyung Hee University Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: NaRi Kim
- Email: nrkim209@daewoong.co.kr
- Phone: 82-10-6611-7051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.