None listed
Conditions
Interventions
Behavioral : Application of a Smartwatch App-Based Mobile Solution:
- Providing personalized target values through risk stratification of cardiovascular risk.
- Offering individual feedback on health
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 12-week follow-up HbA1c changes in the experimental group and the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients with HbA1c < 7% at the 12-week follow-up. The percentage of patients with HbA1c < 6.5% at the 12-week follow-up. The percentage of patients with a weight loss = 5% and HbA1c < 7% at the 12-week follow-up. The percentage of patients with a weight loss = 5% and HbA1c < 6.5% at the 12-week follow-up. The frequency of hypoglycemic events (blood glucose < 70 mg/dL) at the 12-week follow-up. The frequency of severe hypoglycemic events (blood glucose < 54 mg/dL or accompanied by hypoglycemic symptoms) at the 12-week follow-up. Changes in fasting blood glucose at the 12-week follow-up. Changes in weight, waist circumference, and body mass index at the 12-week follow-up. Changes in systolic and diastolic blood pressure at the 12-week follow-up. Changes in blood lipid concentrations (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) at the 12-week follow-up. Changes in the Korean Version of the Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) at the 12-week follow-up. Changes in the risk of developing atherosclerotic cardiovascular disease at the 12-week follow-up. Changes in calorie intake indicators at the 12-week follow-up. Changes in step count, calorie expenditure, physical activity, dietary habits, and sleep collected through the app in the intervention group at the 12-week follow-up. Patient satisfaction at the 12-week follow-up. Economic benefits of digital solution-based diabetes treatment. | — |
Countries
Korea, Republic of
Contacts
Public ContactChanghee Jung
Asan Medical Center
Outcome results
None listed