Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 28, 2016
CompletedFirst Posted
Study publicly available on registry
April 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 7, 2016
March 1, 2016
1.9 years
February 28, 2016
June 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
Baseline through 2 months
Secondary Outcomes (2)
Incidence of minor side effects related to treatment
Baseline through 2 months
Changes in mean interstitial glucose levels measured by CGM
Baseline, 1, 2, 5, and 6 weeks
Study Arms (2)
PES Treatment
EXPERIMENTALEligible 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
Control
NO INTERVENTIONInterstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy, or nursing
- \< HbA1c \< 6
- Permanent pacemakers
- Metal prosthesis
- Resting blood pressure \> 160/ 100 mmHg
- Skin disease
- Treatment with steroids or beta-blockers treatment with psychiatric medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf-Harofeh Medical Center
Ẕerifin, 70300, Israel
Related Publications (1)
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.
PMID: 27997608DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2016
First Posted
April 5, 2016
Study Start
July 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 7, 2016
Record last verified: 2016-03