Diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 4.1 Inclusion Criteria: - Disease Diagnosis: Having diabetes mellitus (diagnosed by oral glucose tolerance test, glycated hemoglobin, etc.). This is to facilitate the targeted evaluation of the management effect of the refined care management model based on mobile APP throughout the care process in the diabetic population and explore ways to improve metabolic indicators. - Age Range: Generally set at [18 - 65 years old]. People in this age group relatively have good self-care ability and physical adaptability and can implement [the management model] well. Meanwhile, it covers young and middle-aged people and some pre-elderly people. These groups are representative in the onset and management of diabetes, ensuring that the research results have relatively extensive applicability and reference value. It is also convenient to observe the effect differences and potential influencing factors of lifestyle changes in different age groups. - Awareness and Willingness: Having clear cognitive ability, being able to understand and sign the informed consent form, indicating that they are aware of the research purpose, process, potential risks and benefits, and voluntarily participate in the research, and are willing to cooperate to complete various guidance measures and follow-up examinations. This is the basis for ensuring the smooth implementation of the research and the validity of the data, guaranteeing the subjective initiative and compliance of the research subjects, and reducing data loss and result deviation caused by dropping out or non-cooperation midway.
Exclusion criteria
Exclusion criteria: 4.2 Exclusion Criteria - Severe Underlying Diseases: Patients with severe cardiovascular and cerebrovascular diseases (e.g., acute myocardial infarction, unstable angina pectoris, severe heart failure, grade ?-? cardiac insufficiency, recent stroke), severe liver or kidney dysfunction (e.g., decompensated cirrhosis, uremic stage of chronic renal failure, acute liver or kidney failure), malignant tumors, or other major diseases that may affect the implementation of the study or interfere with the judgment of research results are excluded. These patients have complex and unstable conditions, making them unable to withstand potential physiological stress caused by lifestyle changes. Additionally, the treatment process of their underlying diseases may mask or confuse the effects of the intervention, which is not conducive to focusing the study on the main goal of diabetes management. This ensures the homogeneity and safety of the study population and eliminates interference from other severe diseases in diabetes management research. - Special Physiological States: Pregnant or lactating women are excluded because women during pregnancy and lactation undergo special physiological changes, with metabolic and nutritional needs different from non-pregnant individuals. Intervention measures may have unpredictable effects on fetuses or infants. Moreover, changes in weight and metabolic indicators during this period are dominated by pregnancy and lactation factors, making it difficult to solely evaluate the effectiveness of the program. This ensures that subjects are in a relatively stable, non-special physiological state, facilitating accurate analysis of the relationship between lifestyle and diabetes management and avoiding interference from special physiological factors on the scientificity and reliability of research results. - Mental Illness or Substance Addiction: Individuals with uncontrolled mental illnesses (e.g., severe depression, schizophrenia) or substance addiction (e.g., alcoholism, drug abuse) are excluded. These conditions may affect patients' ability to understand, implement recommendations, and maintain compliance. Meanwhile, mentally ill patients may experience additional metabolic effects due to psychotropic medications, and the physical functions and metabolic status of substance addicts are complex and chaotic. Both situations hinder the accurate evaluation of the program's role in diabetes management. This ensures that subjects can psychologically and behaviorally cooperate with the implementation of the research program normally, guaranteeing the validity and authenticity of research data and reducing the interference of confounding factors on research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood pressure;blood lipids; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood glucose;body composition;liver function;renal function; | — |
Countries
China
Contacts
Sun Yat-sen University Sun Yat-sen Memorial Hospital