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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Stimulator
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Assaf-Harofeh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PES Treatment

Control

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of minor side effects related to treatment
Changes in mean interstitial glucose levels measured by CGM

Full Information

First Posted
February 28, 2016
Last Updated
June 6, 2016
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02727790
Brief Title
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose
Official Title
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose Lowering Action in Type 2 Diabetes Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PES Treatment
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System
Intervention Type
Device
Intervention Name(s)
Stimulator
Other Intervention Name(s)
BEAC Biomedical Intellistim BE-28TC
Primary Outcome Measure Information:
Title
Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
Time Frame
Baseline through 2 months
Secondary Outcome Measure Information:
Title
Incidence of minor side effects related to treatment
Time Frame
Baseline through 2 months
Title
Changes in mean interstitial glucose levels measured by CGM
Time Frame
Baseline, 1, 2, 5, and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
27997608
Citation
Catalogna M, Doenyas-Barak K, Sagi R, Abu-Hamad R, Nevo U, Ben-Jacob E, Efrati S. Effect of Peripheral Electrical Stimulation (PES) on Nocturnal Blood Glucose in Type 2 Diabetes: A Randomized Crossover Pilot Study. PLoS One. 2016 Dec 20;11(12):e0168805. doi: 10.1371/journal.pone.0168805. eCollection 2016.
Results Reference
derived

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

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