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Abstract
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 HbA1c level 8.1% [0.6%]) completed the trial. At week 20, HbA1c 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 HbA1c reduction. However, it is a safe complementary therapy to improve MAGE in patients with type 2 diabetes.
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1 National Taiwan University Hospital, Division of Endocrinology and Metabolism, Department of Internal Medicine, Taipei, Taiwan (GRID:grid.412094.a) (ISNI:0000 0004 0572 7815); National Taiwan University Hospital, Department of Laboratory Medicine, Taipei, Taiwan (GRID:grid.412094.a) (ISNI:0000 0004 0572 7815)
2 National Cheng Kung University Hospital, Division of Endocrinology and Metabolism, Department of Internal Medicine, Tainan, Taiwan (GRID:grid.412040.3) (ISNI:0000 0004 0639 0054); National Cheng Kung University, College of Medicine, Tainan, Taiwan (GRID:grid.64523.36) (ISNI:0000 0004 0532 3255)
3 Taipei Medical University, Division of Endocrinology and Metabolism, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei, Taiwan (GRID:grid.412896.0) (ISNI:0000 0000 9337 0481); Shuang Ho Hospital, Taipei Medical University, Division of Endocrinology and Metabolism, Department of Internal Medicine, Taipei, Taiwan (GRID:grid.412896.0) (ISNI:0000 0000 9337 0481)
4 Chi Mei Medical Center, Division of Endocrinology and Metabolism, Department of Internal Medicine, Tainan, Taiwan (GRID:grid.413876.f) (ISNI:0000 0004 0572 9255)
5 Division of Endocrinology and Metabolism, Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan (GRID:grid.414746.4) (ISNI:0000 0004 0604 4784)
6 Ditmanson Chia-Yi Christian Hospital, Division of Endocrinology and Metabolism, Department of Internal Medicine, Chia-Yi City, Taiwan (GRID:grid.413878.1) (ISNI:0000 0004 0572 9327); Kaohsiung Christian Hospital, Lutheran Medical Foundation, Kaohsiung, Taiwan (GRID:grid.413878.1)
7 National Taiwan University Hospital, Division of Endocrinology and Metabolism, Department of Internal Medicine, Taipei, Taiwan (GRID:grid.412094.a) (ISNI:0000 0004 0572 7815)
8 National Taiwan University Hospital, Division of Endocrinology and Metabolism, Department of Internal Medicine, Taipei, Taiwan (GRID:grid.412094.a) (ISNI:0000 0004 0572 7815); National Taiwan University, Graduate Institute of Medical Genomics and Proteomics, Taipei, Taiwan (GRID:grid.19188.39) (ISNI:0000 0004 0546 0241); Academia Sinica, Institute of Biomedical Sciences, Taipei, Taiwan (GRID:grid.28665.3f) (ISNI:0000 0001 2287 1366)
9 National Taiwan University Hospital, Division of Endocrinology and Metabolism, Department of Internal Medicine, Taipei, Taiwan (GRID:grid.412094.a) (ISNI:0000 0004 0572 7815); National Taiwan University, Graduate Institute of Medical Genomics and Proteomics, Taipei, Taiwan (GRID:grid.19188.39) (ISNI:0000 0004 0546 0241)
10 Ditmanson Chia-Yi Christian Hospital, Division of Endocrinology and Metabolism, Department of Internal Medicine, Chia-Yi City, Taiwan (GRID:grid.413878.1) (ISNI:0000 0004 0572 9327)
11 National Taiwan University Hospital, Division of Endocrinology and Metabolism, Department of Internal Medicine, Taipei, Taiwan (GRID:grid.412094.a) (ISNI:0000 0004 0572 7815); National Taiwan University, Institute of Epidemiology and Preventive Medicine, Taipei, Taiwan (GRID:grid.19188.39) (ISNI:0000 0004 0546 0241); Medical College, National Taiwan University, Graduate Institute of Clinical Medicine, Taipei, Taiwan (GRID:grid.19188.39) (ISNI:0000 0004 0546 0241)