experiment design: Single-center, single-arm, open-label trial
Inclusion Criteria:
1. Ages 18-70.
2. At least 6 months prior to enrollment, the patient must have been diagnosed with type 2 diabetes mellitus.
3. The glycated hemoglobin level is 7.5%-10.5%.
4. BMI 2 7-40 kg/m2.
5. Patients who, within 12 weeks prior to screening, were treated with 2-3 oral hypoglycemic agents yet still had poorly controlled blood glucose levels, and could maintain the same medication regimen throughout the trial; or those whose blood glucose control was suboptimal despite lifestyle modifications.
6. Stable body weight (defined as a weight change of \<5% within 5 weeks prior to screening)
7. Donation of blood is prohibited during the trial participation period.
8. The subject must sign an Informed Consent Form (ICF), demonstrating their understanding of the purpose and procedures required for this study and their willingness to participate.
9. Be willing and able to comply with all requirements specified in the trial, including but not limited to completing the required assessments, adhering to the visit schedule, and complying with lifestyle restrictions.
10. Fertile female subjects must have a negative urine pregnancy test result during screening and must use contraception throughout the study period.
Primary efficacy endpoint :HbA1c: The difference in HbA1c levels from the baseline period to 6 months post-treatment Observation period: 6 months postoperatively. Secondary efficacy endpoint HbA1c: The difference in HbA1c levels from the baseline period to after treatment Observation periods: 1 month, 3 months, and 12 months post-treatment. Average fasting blood glucose: The average fasting blood glucose level from the baseline period to after treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Weight: Average weight from the baseline period to post-treatment Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Use of hypoglycemic agents: The incidence rate at which researchers determined the need for therapeutic intervention when glycated hemoglobin levels exceeded 8.5%.
Observation periods: 1 month, 3 months, 6 months, and 12 months post-treatment. Safety Indicator 1. Adverse Events and Serious Adverse Events 2. Device defect 3. Intraoperative Instrument Performance Evaluation