Type 2 Diabetes MellitusNCT03102424
Transcutaneous Electrical Nerve Stimulator to Improve Blood Glucose Control in Patients With Type 2 Diabetes Mellitus
A study testing Transcutaneous Electrical Nerve Stimulator (DW1330) in people with Type 2 Diabetes Mellitus, run by Taiwan Resonant Waves Research Corporation at 6 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Transcutaneous Electrical Nerve Stimulator (DW1330)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 6 sitesTaiwan
- Study dates
- 10 Apr 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects age 30 through 80 years;
- Type 2 diabetes mellitus (T2DM) patients on stable oral anti-diabetic drugs for more than 3 months, and can maintain stable during study maintenance period;
- HbA1c between 7.5 and 10% inclusive;
- Subjects who are able and willing to perform self-monitoring of plasma glucose and self-administration of study device for the entire trial period;
- Subjects who are able and willing to keep a diary;
- Able and willing to sign informed consent and return for follow-up assessments.
Who cannot join
- 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;
- Subjects with prior pancreatitis;
- Subjects with insulin therapy (except for short term uses no longer than 7 days) or injectable antihyperglycemic agents (AHAs) within 3 months;
- Female with a positive pregnancy test, planning to become pregnant during screening, active treatment, or the follow up period, breastfeeding, or judged to be using inadequate contraceptive methods;
- Subjects who underwent previous intra abdominal, GI tract surgery or a major abdominal trauma within 6 months prior to screening visit;
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- Subjects with other implanted electrical stimulation devices;
- Subject has any unresolved adverse skin condition in the area of device placement;
- ALT/AST greater than 3 x upper limit of the institution's normal range (ULN) and/or total bilirubin ≥ 2.0 x ULN, active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, hepatic cirrhosis, primary biliary cirrhosis, or active symptomatic gallbladder disease;
- Subjects with moderate or severe renal impairment (serum creatinine ≥1.5 mg/dL in males or ≥ 1.4 mg/dL in females or urine microalbumin-creatinine ratio (ACR) >300 mg/g), conditions of congenital renal glucosuria, unstable or rapid progressing renal disease;
- Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells or any other clinically significant hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia, coagulopathy);
- Subjects with acute metabolic complications (such as ketoacidosis, lactic acidosis or hyperosmolar), proliferative diabetic retinopathy or macular edema within 6 months before screening;
- Subjects with a history of malignancy ≤5 years prior to screening, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer;
- Subjects a history of alcohol or drug abuse within 1 year prior to screening;
- Subjects who received another investigational agent within 30 days prior to screening;
- Subjects who are unlikely to be available for follow-up as specified in the protocol;
- Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures;
- Subjects with conditions that, in the judgment of the investigator, precludes successful participation to the study;
- Subjects with fever(body temperature> 37.5°C), perceptual function lost, or any metal implants.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Chia-Yi Christian Hospital
Chiayi City, 600
Far Eastern Memorial Hospital
New Taipei City, 220
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, 23561
National Cheng Kung University Hospital
Tainan, 704
Chi Mei Hospital
Tainan, 710
National Taiwan University Hospital
Taipei, 100
About this study
Official title: A Prospective, Double Blind, Randomized, Placebo- Controlled Trial of Transcutaneous Electrical Nerve Stimulator (DW1330) to Improve Blood Glucose Control in Patients With Type 2 Diabetes
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.
Read the 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:
- DW1330
- 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Transcutaneous Electrical Nerve Stimulator (DW1330), Sham DW1330 device
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulator (DW1330)Device
Also called Dragon Waves Resonant Home Care Electronic Nerve Stimulator (DW1330), DW1330, T2DM-MENS
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.
Sham DW1330 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulator (DW1330) | Experimental | 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. Receives: Device: Transcutaneous Electrical Nerve Stimulator (DW1330) |
| Sham DW1330 device | Placebo comparator | 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. Receives: Device: Sham DW1330 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks, 2 weeks of screening, 20 weeks of treatment, and 2 weeks of post-treatment follow-up
Secondary outcomes (5)
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%
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline at visit 2, and visit 3, 4, 5, 6, 7, 8 of treatment [up to 20 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start10 Apr 2017
- Primary completion15 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Resonant Waves Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee-Ming Chuang, M.D., Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102424
- Sponsor's protocol ID
- TRWRDM1604001
- Other IDs
- 1056030994
- Status last verified
- Mar 2021
- First submitted
- 26 Dec 2016
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Randomized, Placebo- Controlled Trial of Transcutaneous Electrical Nerve Stimulator (DW1330) to Improve Blood Glucose Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03102424
- Acronym / sponsor ID
- TRWRDM1604001
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Taiwan Resonant Waves Research CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- DW1330
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulator (DW1330) | Experimental | 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. |
| Sham DW1330 device | Placebo comparator | Device: Sham DW1330 deviceThe 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects age 30 through 80 years;
- Type 2 diabetes mellitus (T2DM) patients on stable oral anti-diabetic drugs for more than 3 months, and can maintain stable during study maintenance period;
- HbA1c between 7.5 and 10% inclusive;
- Subjects who are able and willing to perform self-monitoring of plasma glucose and self-administration of study device for the entire trial period;
- Subjects who are able and willing to keep a diary;
Key exclusion criteria (19 listed)
- 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;
- Subjects with prior pancreatitis;
- Subjects with insulin therapy (except for short term uses no longer than 7 days) or injectable antihyperglycemic agents (AHAs) within 3 months;
- Female with a positive pregnancy test, planning to become pregnant during screening, active treatment, or the follow up period, breastfeeding, or judged to be using inadequate contraceptive methods;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulator (DW1330)Also: Dragon Waves Resonant Home Care Electronic Nerve Stimulator (DW1330), DW1330, T2DM-MENSThe 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) |
| Sham DW1330 deviceThe 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. | Device | Sham DW1330 device |
Primary outcome
Change in HbA1c values to evaluate of the effect of DW1330
Time frame: 24 weeks, 2 weeks of screening, 20 weeks of treatment, and 2 weeks of post-treatment follow-up
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.
5 secondary outcomes
To evaluate the change from baseline in the percentage of subject who achieve HbA1c < 7%
Time frame: 24 weeks, 2 weeks of screening, and 20 weeks of treatment
Change from baseline in FPG
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
Time frame: baseline at visit 2, and visit 4, 6, 8 of treatment [up to 20 weeks]
Change from baseline in body weight
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
Time frame: baseline at visit 2, and visit 3, 4, 5, 6, 7, 8 of treatment [up to 20 weeks]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee-Ming Chuang, M.D., Ph.D. principal investigator
National Taiwan University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulator (DW1330) in people with Type 2 Diabetes Mellitus, run by Taiwan Resonant Waves Research Corporation at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c values to evaluate of the effect of DW1330 (time frame: 24 weeks, 2 weeks of screening, 20 weeks of treatment, and 2 weeks of post-treatment follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.