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

This is an interventional supportive care trial for Type 2 Diabetes Mellitus Read More

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.