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

Shamir Medical Center (Assaf-Harofeh)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Device: Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02727790

HTA6446 (Other Identifier)

129/12

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

PES Treatment

Experimental group

Description:

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

Treatment:

Device: Stimulator

Control

No Intervention group

Description:

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