Type 2 Diabetes
Conditions
Interventions
Intervention Group:CMNT dietary protocol combined with Trans-Theoretical Model intervention, featuring cyclical 5-day meal replacement and 10-day regular diet phases, supported by mobile application m
Control Group:Standard community chronic disease management model incorporating Trans-Theoretical Model, TCM nutritional intervention, quarterly fasting blood glucose monitoring, blood pressure monito
Sponsors
University of South China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years (inclusive), with no language, visual, or hearing impairments;2.Diagnosed with Type 2.Diabetes Mellitus (T2DM) for at least 2 years, according to the 2020 American Diabetes Association (ADA) Standards of Medical Care in Diabetes;3.Weight stable for at least 3 months prior to the study (weight change < 4 kg);4.BMI between 18.0 and 35.0 kg/m² (inclusive) at screening;5.Willing and able to accurately use a home blood glucose meter for self-monitoring, able to understand and comply with the study procedures, voluntarily participating in the study, and providing informed consent;6.Able to successfully complete a 2-3 week trial preparation period.
Exclusion criteria
Exclusion criteria: 1.Scheduled or expected to be hospitalized during the trial.2.Physically or mentally unable to comply with the procedures required by the study protocol.3.Experienced a grade 3 hypoglycemic event within 90 days prior to screening, or had hospitalization or emergency treatment due to hyperglycemia, diabetic ketoacidosis, lactic acidosis, hyperosmolar non-ketotic coma, or diabetes-related issues.4.Has severe major diseases that may affect cognitive function (such as diseases of the heart, lungs, liver, kidneys, blood system, etc.).5.History of depression within the last 2 years.6.History of alcohol, smoking, or substance abuse or dependence within the last 2 years.7.History of cerebrovascular disease such as cerebral infarction, cerebral hemorrhage, central nervous system infections, brain tumors, or other focal brain injuries.8.Physically or mentally unable to comply with the procedures required by the study protocol.9.Diagnosed with New York Heart Association (NYHA) class III or IV decompensated heart failure.10.Allergic to CMNT components.11.History of cancer within the last 5 years.12.Diagnosed with New York Heart Association (NYHA) class III or IV decompensated heart failure.13.History of unstable angina, coronary artery bypass surgery, myocardial infarction, or stent implantation.14.Other conditions deemed inappropriate for participation by the investigator or the medical expert of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetes remission status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetes Quality of Life;Body Mass Index (BMI);Systolic Blood Pressure / Diastolic Blood Pressure.;glycosylated hemoglobin; Fasting Blood Glucose;Postprandial Blood Glucose.;Stage of Behavior Change;Quality of life;Self-management Behavior; | — |
Countries
China
Contacts
Public ContactZhang Siyao
School of Nursing, University of South China
Outcome results
None listed