Transcutaneous Electrical Nerve Stimulator to Improve Blood Glucose Control in Patients With Type 2 Diabetes Mellitus

Inclusion Criteria: 1. Male and female subjects age 30 through 80 years; 2. Type 2 diabetes mellitus (T2DM) patients on stable oral anti-diabetic drugs for more than 3 months, and can maintain stable during study maintenance period; 3. HbA1c between 7.5 and 10% inclusive; 4. Subjects who are able and willing to perform self-monitoring of plasma glucose and self-administration of study device for the entire trial period; 5. Subjects who are able and willing to keep a diary; 6. Able and willing to sign informed consent and return for follow-up assessments. Exclusion Criteria: 1. Subject has had any of the following new diagnoses within 1 year of screening: myocardial infarction, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure(NYHA III-IV), ventricular rhythm disturbances or thromboembolic disease; 2. Subjects with prior pancreatitis; 3. Subjects with insulin therapy (except for short term uses no longer than 7 days) or injectable antihyperglycemic agents (AHAs) within 3 months; 4. Female with a positive pregnancy test, planning to become pregnant during screening, active treatment, or the follow up period, breastfeeding, or judged to be using inadequate contraceptive methods; 5. Subjects who underwent previous intra abdominal, GI tract surgery or a major abdominal trauma within 6 months prior to screening visit; 6. Subjects with other implanted electrical stimulation devices; 7. Subject has any unresolved adverse skin condition in the area of device placement; 8. ALT/AST greater than 3 x upper limit of the institution's normal range (ULN) and/or total bilirubin ≥ 2.0 x ULN, active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, hepatic cirrhosis, primary biliary cirrhosis, or active symptomatic gallbladder disease; 9. Subjects with moderate or severe renal impairment (serum creatinine ≥1.5 mg/dL in males or ≥ 1.4 mg/dL in females or urine microalbumin-creatinine ratio (ACR) \>300 mg/g), conditions of congenital renal glucosuria, unstable or rapid progressing renal disease; 10. Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells or any other clinically significant hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia, coagulopathy); 11. Subjects with acute metabolic complications (such as ketoacidosis, lactic acidosis or hyperosmolar), proliferative diabetic retinopathy or macular edema within 6 months before screening; 12. Subjects with a history of malignancy ≤5 years prior to screening, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer; 13. Subjects a history of alcohol or drug abuse within 1 year prior to screening; 14. Subjects who received another investigational agent within 30 days prior to screening; 15. Subjects who are unlikely to be available for follow-up as specified in the protocol; 16. Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures; 17. Subjects with conditions that, in the judgment of the investigator, precludes successful participation to the study; 18. Subjects with fever(body temperature\> 37.5°C), perceptual function lost, or any metal implants.