MedTrace Logo

Transcutaneous Electrical Nerve Stimulator to Improve Blood Glucose Control in Patients With Type 2 Diabetes Mellitus

NCT03102424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-04-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulator (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.

DEVICE

Sham DW1330 device

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.

Sponsors & Collaborators

  • Taiwan Resonant Waves Research Corporation

    lead INDUSTRY

Principal Investigators

  • Lee-Ming Chuang, M.D., Ph.D. · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2020-07-15
Completion
2020-07-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102424 on ClinicalTrials.gov