A study to investigate the effectiveness of a mobile app-based health management service in improving Type 2 diabetes
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008933
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 366
(1) Participants insured with Kyobo Life Insurance.
(2) Men and women aged 20-55.
(3) Individuals who, during hospital visits or check-ups, have fasting blood glucose levels = 126 mg/dL or HbA1c levels = 6.5%, or those who have already been diagnosed with diabetes and are undergoing lifestyle modification therapy or diabetes medication treatment (meeting at least one of these three criteria).
(4) Individuals who have consented to participate in the study.
(5) Individuals who own an Android phone compatible with Galaxy Watch 4 integration.
(6) Individuals with a hemoglobin A1c (HbA1c) level between 6.5% and 10.0% within the last 3 months at the screening point.
(1) Individuals with Type 1 diabetes.
(2) Individuals who have received insulin within the past 3 months at the screening point.
(3) Individuals who have newly started or changed their diabetes medication within the past 3 months at the screening point.
(4) Individuals with underlying cardiovascular diseases (angina, myocardial infarction, heart failure, aortic diseases, moderate to severe valvular diseases, arrhythmias, cardiomyopathy, etc.).
(5) Individuals with underlying cerebrovascular diseases (stroke, cerebral hemorrhage, cerebral aneurysms, etc.).
(6) Patients with end-stage renal failure.
(7) Individuals with underlying peripheral vascular diseases (arterial occlusion in the extremities, etc.).
(8) Pregnant or lactating women or women with plans to become pregnant within the next 3 months.
(9) Individuals with alcohol addiction or substance abuse.
(10) Individuals using medications such as steroids that can affect blood glucose levels.
(11) Individuals with arrhythmias such as atrial fibrillation or severe bradycardia (heart rate < 50 beats per minute).
(12) Individuals for whom it is difficult to measure physical information with a smartwatch (due to neurological disorders such as tremors, blood clotting disorders, blood-thinning medication use, or tattoos on the wrist where the watch is worn).
(13) Patients with an expected lifespan of less than 2 years.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The 12-week follow-up HbA1c changes in the experimental group and the control group.
- Secondary Outcome Measures
Name Time Method