A randomized trial on the effect of transcutaneous electrical nerve stimulator on glycemic control in patients with type 2 diabetes

• Published in: Scientific reports Vol. 13; no. 1; pp. 2662 - 10
• Main Authors: Lu, Jin-Ying, Ou, Horng-Yih, Wu, Chung-Ze, Yang, Chwen-Yi, Jiang, Ju-Ying, Lu, Chieh-Hsiang, Jiang, Yi-Der, Chang, Tien-Jyun, Chang, Yi-Cheng, Hsieh, Meng-Lun, Wu, Wan-Chen, Li, Hung-Yuan, Du, Ye-Fong, Lin, Ching-Han, Hung, Hao-Chang, Tien, Kai-Jen, Yeh, Nai-Cheng, Lee, Shang-Yu, Yu, Hui-I., Chuang, Lee-Ming
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 15.02.2023; Nature Publishing Group; Nature Portfolio
• Subjects: 631/61; 692/163; 692/308; 692/699; Animal models; Antidiabetics; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - drug therapy; Glycemic Control; Humanities and Social Sciences; Humans; Hypoglycemic Agents - therapeutic use; Male; Middle Aged; multidisciplinary; Placebos; Science; Science (multidisciplinary); Statistical analysis; Transcutaneous Electric Nerve Stimulation; Transcutaneous electrical nerve stimulation-TENS
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-023-29791-7

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). Glycemic variability, measured as mean amplitude of glycemic excursion (MAGE) at week 20 were significantly different in the TENS group vs. the placebo group (66 mg/dL [95% CI 58, 73] vs. 79 mg/dL [95% CI 72, 87]) ( P  = 0.009). 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.