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Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02727790
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
23
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The epidemic nature of type 2 diabetes mellitus, along with the downsides of current treatments, has raised the need for therapeutic alternatives. The aim of this study is to evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral electrical stimulation (PES) as an alternative treatment for diabetes.

Condition or Disease Intervention/Treatment Phase
  • Device: Stimulator
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose Lowering Action in Type 2 Diabetes Patients
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: PES Treatment

Eligible patients will receive daily 5 min PES treatment for two weeks. Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) continuous glucose monitor (CGM) System

Device: Stimulator
Other Names:
  • BEAC Biomedical Intellistim BE-28TC

    		•
    No Intervention: Control

    Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with hypoglycemia, and/ or adverse events that are related to treatment [Baseline through 2 months]

    Secondary Outcome Measures

    1. Incidence of minor side effects related to treatment [Baseline through 2 months]

    2. Changes in mean interstitial glucose levels measured by CGM [Baseline, 1, 2, 5, and 6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients diagnosed with type II diabetes, for at least one year prior to randomization

    • Body mass index BMI < 35 Kg/m2

    • Stable glucose lowering drugs regimen for at least one month prior to randomization

    • Capable of giving informed consent

    Exclusion Criteria:

    • Pregnancy, or nursing

    • 10< HbA1c < 6

    • Permanent pacemakers

    • Metal prosthesis

    • Resting blood pressure > 160/ 100 mmHg

    • Skin disease

    • Treatment with steroids or beta-blockers treatment with psychiatric medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assaf-Harofeh Medical Center Zerifin Israel 70300

    Sponsors and Collaborators

    • Assaf-Harofeh Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assaf-Harofeh Medical Center
    ClinicalTrials.gov Identifier:
    NCT02727790
    Other Study ID Numbers:
    • 129/12
    • HTA6446
    First Posted:
    Apr 5, 2016
    Last Update Posted:
    Jun 7, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Jun 7, 2016