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

NCT03102424 | Completed

• 2 other identifiers: TRWRDM16040011056030994
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 6

Brief 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

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  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%

  24 weeks, 2 weeks of screening, and 20 weeks of treatment

• Change from baseline in FPG

  baseline at visit 2, and visit 3, 4, 5, 6, 7, 8 of treatment [up to 20 weeks]

• Evaluate the efficacy of SMBG

  baseline at visit 2, and visit 4, 6, 8 of treatment [up to 20 weeks]

• Change from baseline in body weight

  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

  baseline at visit 2, and visit 3, 4, 5, 6, 7, 8 of treatment [up to 20 weeks]

Other Outcomes (1)

• Change from baseline of inflammatory biomarkers

  baseline at 2 week,and 20 week

Study Arms (2)

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.

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.

Device: Sham DW1330 device

Interventions

Transcutaneous Electrical Nerve Stimulator (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

Transcutaneous Electrical Nerve Stimulator (DW1330)

Sham DW1330 device 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.

Sham DW1330 device

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Taiwan Resonant Waves Research Corporation: lead

Study Sites (6)

Chia-Yi Christian Hospital

Chiayi City, 600, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, 23561, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Chi Mei Hospital

Tainan, 710, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lee-Ming Chuang, M.D., Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: April 5, 2017
• Study Start: April 10, 2017
• Primary Completion: July 15, 2020
• Study Completion: July 31, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

TW (6)