Transcutaneous Electrical Nerve Stimulator to Improve Blood Glucose Control in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The primary study objective is to demonstrate the use of "Dragon Waves Resonant Home Care"
      Electronic Nerve Stimulator (DW1330) is associated with improvement of blood glucose control,
      as measured by change of glycated hemoglobin (HbA1c). The second study objectives are to
      demonstrate that DW1330 is associated with the mechanism of glycemic control and inflammation
      pathways. The study is also aimed to investigate the safety of DW1330.
    

Detailed description: 
      This is a multi-center, prospective, double blind, randomized, placebo-controlled trial of
      transcutaneous electrical nerve stimulator (DW1330) to improve blood glucose control in
      patients with type 2 diabetes. Subjects with type 2 diabetes who meet inclusion/exclusion
      criteria will be randomized to either of the 2 groups below:

        1. DW1330

        2. Placebo (sham TENS delivering ineffective pulse wave)

      After enrollment, subjects will be randomly assigned to receive one of the study treatments
      in a double-blind fashion. All patients enrolled should perform 1 treatment within 1 hour
      after dinner 5 days a week. The end of a 20 week treatment period, subjects will be followed
      for an additional 2 weeks for safety follow-up. The time frame includes 2 weeks of screening,
      20 weeks of treatment, and 2 weeks of post-treatment follow-up.

      Study visits will occur every 2 or 4 weeks depending on the study phase. At randomization
      visit study device will be dispensed at the site, during the treatment period visits, all
      Adverse Events (AEs) as well as follow-up for all AEs that have not been resolved will be
      recorded, changes to concomitant medications will be noted, vital signs will be taken, and
      efficacy evaluations will be performed as well. Investigators, site staff, subjects, and the
      study team will be blinded to the device assigned. The study includes collection of blood and
      urine samples. The end-of-treatment visit and the last estimation of glycemic control will
      occur at week 20 (visit 8) for all subjects. In addition, 2-week follow up will occur in
      order to collect safety data after the device is returned. The final visit will be at week 22
      (visit 9). Subjects will be encouraged to complete all planned visits regardless of their
      adherence to study device administration.
    

Intervention name(s): Transcutaneous Electrical Nerve Stimulator (DW1330); Sham DW1330 device
Intervention type(s): Device; Device
Intervention description(s): The 20 weeks of treatment of the DW1330 device, all the patients enrolled should perform 1 treatment within 1 hour after dinner 5 days a week.; The Sham DW1330 device will be masked by the same appearance as the study device (DW1330). The usage of time and location of Sham DW1330 device will be completely the same with study device (DW1330). However, the electronic model, including the frequency and time consistence of electronic stimulation are different between the Sham DW1330 device and the study device (DW1330). The 20 weeks of treatment of the DW1330 device, all the patients enrolled should perform 1 treatment within 1 hour after dinner 5 days a week.
Other intervention name(s): Dragon Waves Resonant Home Care Electronic Nerve Stimulator (DW1330); DW1330; T2DM-MENS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care