Study design and participants
type 2 diabetes
TYPE 2 DIABETES, BLIND
This was a multi-center, prospective, double blind, randomized, placebo-controlled trial of transcutaneous electrical nerve stimulator (TENS) to improve glycemic control in patients with type 2 diabetes (ClinicalTrials.gov Identifier: NCT03102424). The study and all experimental protocols were approved by Institutional Review Boards of the six joining hospitals (National Taiwan University Hospital, National Cheng Kung University Hospital, Taipei Medical University, Chi Mei Medical Center, Far Eastern Memorial Hospital, and Ditmanson Chia-Yi Christian Hospital), and written informed consent was obtained from each study participant. All experiments were carried out in accordance with relevant guidelines and regulations.Subjects with type 2 diabetes who met all the inclusion but none of the exclusion criteria were randomized with a 1:1 allocation into either of the 2 groups below: 1. TENS, 2. placebo (sham TENS delivering ineffective pulse wave). The inclusion criteria, exclusion criteria and sample size determination are detailed in the Methods Section in Supplementary Material. A schematic diagram of study design is depicted in Supplementary Fig. 