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

Assaf-Harofeh Medical Center12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

StimulatorDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Assaf-Harofeh Medical Center

Ẕerifin, Israel

Outcomes

Primary Outcomes

Number of participants with hypoglycemia, and/ or adverse events that are related to treatment

Time frame: Baseline through 2 months

Secondary Outcomes

Incidence of minor side effects related to treatment

Time frame: Baseline through 2 months

Changes in mean interstitial glucose levels measured by CGM

Time frame: Baseline, 1, 2, 5, and 6 weeks

Data from ClinicalTrials.gov

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