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

Jin Ying Lu; Horng Yih Ou; Chung Ze Wu; Chwen Yi Yang; Ju Ying Jiang; Chieh Hsiang Lu; Yi Der Jiang; Tien Jyun Chang; Yi Cheng Chang; Meng Lun Hsieh; Wan Chen Wu; Hung Yuan Li; Ye Fong Du; Ching Han Lin; Hao Chang Hung; Kai Jen Tien; Nai Cheng Yeh; Shang Yu Lee; Hui I. Yu; Lee Ming Chuang

doi:10.1038/s41598-023-29791-7

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

Jin Ying Lu, Horng Yih Ou, Chung Ze Wu, Chwen Yi Yang, Ju Ying Jiang, Chieh Hsiang Lu, Yi Der Jiang, Tien Jyun Chang, Yi Cheng Chang, Meng Lun Hsieh, Wan Chen Wu, Hung Yuan Li, Ye Fong Du, Ching Han Lin, Hao Chang Hung, Kai Jen Tien, Nai Cheng Yeh, Shang Yu Lee, Hui I. Yu, Lee Ming Chuang

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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 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.

Original language	English
Article number	2662
Journal	Scientific reports
Volume	13
Issue number	1
DOIs	https://doi.org/10.1038/s41598-023-29791-7
Publication status	Published - 2023 Dec

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Lu, J. Y., Ou, H. Y., Wu, C. Z., Yang, C. Y., Jiang, J. Y., Lu, C. H., Jiang, Y. D., Chang, T. J., Chang, Y. C., Hsieh, M. L., Wu, W. C., Li, H. Y., Du, Y. F., Lin, C. H., Hung, H. C., Tien, K. J., Yeh, N. C., Lee, S. Y., Yu, H. I., & Chuang, L. M. (2023). A randomized trial on the effect of transcutaneous electrical nerve stimulator on glycemic control in patients with type 2 diabetes. Scientific reports, 13(1), Article 2662. https://doi.org/10.1038/s41598-023-29791-7

@article{34cb5afe5d3b437ebfc6c263592f7281,

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

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.",

author = "Lu, {Jin Ying} and Ou, {Horng Yih} and Wu, {Chung Ze} and Yang, {Chwen Yi} and Jiang, {Ju Ying} and Lu, {Chieh Hsiang} and Jiang, {Yi Der} and Chang, {Tien Jyun} and Chang, {Yi Cheng} and Hsieh, {Meng Lun} and Wu, {Wan Chen} and Li, {Hung Yuan} and Du, {Ye Fong} and Lin, {Ching Han} and Hung, {Hao Chang} and Tien, {Kai Jen} and Yeh, {Nai Cheng} and Lee, {Shang Yu} and Yu, {Hui I.} and Chuang, {Lee Ming}",

note = "Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = dec,

doi = "10.1038/s41598-023-29791-7",

language = "English",

volume = "13",

journal = "Scientific reports",

issn = "2045-2322",

publisher = "Nature Publishing Group",

number = "1",

}

Lu, JY, Ou, HY, Wu, CZ, Yang, CY, Jiang, JY, Lu, CH, Jiang, YD, Chang, TJ, Chang, YC, Hsieh, ML, Wu, WC, Li, HY, Du, YF , Lin, CH , Hung, HC, Tien, KJ, Yeh, NC, Lee, SY, Yu, HI & Chuang, LM 2023, 'A randomized trial on the effect of transcutaneous electrical nerve stimulator on glycemic control in patients with type 2 diabetes', Scientific reports, vol. 13, no. 1, 2662. https://doi.org/10.1038/s41598-023-29791-7

TY - JOUR

T1 - A randomized trial on the effect of transcutaneous electrical nerve stimulator on glycemic control in patients with type 2 diabetes

AU - Lu, Jin Ying

AU - Ou, Horng Yih

AU - Wu, Chung Ze

AU - Yang, Chwen Yi

AU - Jiang, Ju Ying

AU - Lu, Chieh Hsiang

AU - Jiang, Yi Der

AU - Chang, Tien Jyun

AU - Chang, Yi Cheng

AU - Hsieh, Meng Lun

AU - Wu, Wan Chen

AU - Li, Hung Yuan

AU - Du, Ye Fong

AU - Lin, Ching Han

AU - Hung, Hao Chang

AU - Tien, Kai Jen

AU - Yeh, Nai Cheng

AU - Lee, Shang Yu

AU - Yu, Hui I.

AU - Chuang, Lee Ming

PY - 2023/12

Y1 - 2023/12

N2 - 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.

AB - 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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DO - 10.1038/s41598-023-29791-7

M3 - Article

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AN - SCOPUS:85148115090

SN - 2045-2322

VL - 13

JO - Scientific reports

JF - Scientific reports

IS - 1

M1 - 2662

ER -

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

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