diabetes
Conditions
Interventions
Group A (stimulation group 30 minutes before meal):Ear point stimulation is performed 30 minutes before each daily dinner (from 17:00 to 20:30), for 30 minutes each time, once a day, on both sides of
Group B (stimulation group 30 minutes after meal):Ear acupuncture stimulation is performed 30 minutes after each evening meal. Each session lasts for 30 minutes. It is conducted once a day, and both s
Group C (Basic Treatment Group):Only provide basic treatment, without conducting auricular acupuncture intervention.
Sponsors
Chinese Academy of Traditional Chinese Medicine Guang'anmen Hospital - Jinan Branch
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Meet the core diagnostic criteria for type 2 diabetes of the WHO (2006 edition) and the supplementary report of 2011; 2) Be aged between 18 and 65 years old, with no gender restrictions; 3) Have a disease course of type 2 diabetes of no more than 5 years since diagnosis; 4) Have good compliance with the observation and treatment by the researchers; 5) Voluntarily participate in this study and sign the informed consent form; 6) Have a stable diet, exercise and lifestyle, and have not used oral hypoglycemic drugs, insulin or other hypoglycemic agents in the past 3 months, or have maintained the same hypoglycemic regimen for the past 3 months; the coefficient of variation of fasting blood glucose in the 3 days before treatment and on the day of treatment is less than 16%; 7) If hypoglycemic drugs are used, only dipeptidyl peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter 2 inhibitors (SGLT-2i), sulfonylureas, biguanides, or their combinations (excluding insulin and insulin analogues) are allowed, and the type and dosage of hypoglycemic drugs must remain unchanged during the study; 8) At the time of enrollment, blood glucose must be within the target range: fasting blood glucose (FPG) 7.0 - 10.0 mmol/L or 2-hour postprandial blood glucose (PG2h) 11.1 - 18.0 mmol/L; 9) Have not used glucagon-like peptide-1 receptor agonists (GLP-1RA, such as semaglutide, dulaglutide, liraglutide, etc.) in the past 3 months; if hypoglycemic drugs other than GLP-1RA (such as insulin) have been used in the past 3 months, they must be discontinued for at least 1 week, and blood glucose must be rechecked to meet the criteria in item 8) before enrollment.
Exclusion criteria
Exclusion criteria: 1) Gestational diabetes, secondary diabetes (such as that caused by pancreatitis or Cushing's syndrome); 2) Patients with concurrent ketoacidosis, cardiovascular and cerebrovascular diseases, severe diseases of the endocrine and hematopoietic systems other than diabetes, or mental illness; 3) Pregnant, planning to become pregnant, or lactating women; 4) Those with severe skin lesions in the concha area or absent auricles; 5) Those who cannot tolerate conventional electrical stimulation; 6) Those currently participating in other clinical trials or who are unable to understand and cooperate with the entire treatment process during the study period. Note: Any patient meeting any of the above criteria should be excluded. Supplementary instructions: 1) If a subject experiences a significant increase in blood glucose during the study (such as FPG > 13.9 mmol/L or PG2h > 22.0 mmol/L) and requires emergency intervention, the type, dosage, administration time of the drugs used for intervention, and changes in blood glucose should be recorded in detail. This data will be included in the safety analysis and efficacy correction. 2) Blood glucose should be monitored during the washout period. If there is a sharp fluctuation in blood glucose or a risk of acute complications, the enrollment process should be immediately terminated and standardized treatment should be provided.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-Hour Postprandial Blood Glucose,PG2h; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose,FBG;insulin resistance index,insulin sensitivity index;Glycated Albumin,GA Serum C-peptide;1-Hour Postprandial Blood Glucose,PG1h;Blood glucose fluctuation indicators; | — |
Countries
China
Contacts
Public ContactZhai Xu
Chinese Academy of Chinese Medicine Graduate School
Outcome results
None listed