An interventional study of Transcutaneous Electrical Nerve Stimulator (DW1330) and Sham DW1330 device in Type 2 Diabetes Mellitus, sponsored by Taiwan Resonant Waves Research Corporation. Completed at 6 sites in Taiwan. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Taiwan Resonant Waves Research Corporation · Not applicable, Interventional, and Supportive care
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.
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:
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 160 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →This is the only study on the registry with Taiwan Resonant Waves Research Corporation as lead sponsor.
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Exclusion Criteria:
Subject has had any of the following new diagnoses within 1 year of screening:
myocardial infarction, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure(NYHA III-IV), ventricular rhythm disturbances or thromboembolic disease;
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: Transcutaneous Electrical Nerve Stimulator (DW1330)
The 20 weeks of treatment of the Sham DW1330 device, all the patients enrolled should perform 1 treatment within 1 hour after dinner 5 days a week.
Device: Sham DW1330 device
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.
Also known as: Dragon Waves Resonant Home Care Electronic Nerve Stimulator (DW1330), DW1330, T2DM-MENS
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.
Change in HbA1c values to evaluate of the effect of DW1330
The primary study objective is to demonstrate the use of DW1330 is associated with improvement of blood glucose control, as measured by changes in glycated hemoglobin (HbA1c) values in comparison with placebo on blood glucose control parameters after 20 weeks of treatment. The time frame includes 2 weeks of screening, 20 weeks of treatment, and 2 weeks of post-treatment follow-up.
Time frame: 24 weeks, 2 weeks of screening, 20 weeks of treatment, and 2 weeks of post-treatment follow-up
To evaluate the change from baseline in the percentage of subject who achieve HbA1c < 7%
compare the test group and placebo group in percentage of subjects who achieve HbA1c \< 7%
Time frame: 24 weeks, 2 weeks of screening, and 20 weeks of treatment
Change from baseline in FPG
Change from baseline in Fasting plasma glucose compare with test and control group
Time frame: baseline at visit 2, and visit 3, 4, 5, 6, 7, 8 of treatment [up to 20 weeks]
Evaluate the efficacy of SMBG
Change from baseline in evaluate the efficacy of self monitoring blood glucose
Time frame: baseline at visit 2, and visit 4, 6, 8 of treatment [up to 20 weeks]
Change from baseline in body weight
Change from baseline in body weight compare with test and control group
Time frame: baseline at visit 2, and visit 3, 4, 5, 6, 7, 8 of treatment [up to 20 weeks]
Change from baseline in OAD drugs description
compare the change of OAD drugs description following a 20 weeks treatment of DW1330 versus placebo
Time frame: baseline at visit 2, and visit 3, 4, 5, 6, 7, 8 of treatment [up to 20 weeks]
Change from baseline of inflammatory biomarkers
The exploratory objective is to detect the change of biomarkers related to body glucose level
Time frame: baseline at 2 week,and 20 week
Plan to share: Undecided
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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