A Randomized Trial on the Effect of Transcutaneous Electrical Nerve Stimulator on Glycemic Control in Patients with Type 2 Diabetes

Transcutaneous electrical nerve stimulator (TENS) has been demonstrated to be beneficial in glycemic control in animal models, but its application in humans has not been well studied. We randomly assigned 160 patients with type 2 diabetes on oral antidiabetic drugs 1:1 to the TENS study device (n=81) and placebo (n=79). 147 (92%) randomized participants (mean [SD] age 59 [10] years, 92 men [58%], mean [SD] baseline HbA 1c level 8.1% [0.6%]) completed the trial. At week 20, HbA 1c decreased from 8.1% to 7.9% in the TENS group (-0.2% [95% CI: -0.4% to -0.1%]) and from 8.1% to 7.8% in the placebo group (-0.3% [95% CI: -0.5% to -0.2%]) ( P = 0.821). Mean amplitude of glycemic excursion (MAGE) at week 20 were significantly different (66 mg/dL [95% CI: 58, 73] vs. 79 mg/dL [95% CI: 72, 87]) ( P = 0.009). Besides, we noticed that hypoglycemia accounted for 6/54 (11%) of total adverse events and 14/46 (30%) in the TENS vs. the placebo groups. Our study provides the clinical evidence for the first time in humans that TENS does not demonstrate a statistically significant HbA 1c reduction. However, it is a safe complementary therapy to improve MAGE in patients with type 2 diabetes.