NCT04018586

AVACEN Hand Heating on Fasting Blood Glucose

AVACEN Treatment Method on Fasting and Postprandial Blood Glucose

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Jeff Moore · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on fasting blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject was tested while using each of these three devices on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 30 minutes that the device was used.

Conditions

• Hyperglycemia
• Hypertension

Interventions

Type	Name	Description
DEVICE	AVACEN 100	AVACEN 100 pulls a -30mmHg vacuum around hand from wrist down and applies heat (108 farenheit) to the palm and will be applied for 30 minutes
DEVICE	AVACEN 100 Heat Only	AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes
DEVICE	AVACEN Sham	AVACEN 100 neither heats nor pulls a vacuum to hand

Timeline

• Start date: 2019-02-28
• Primary completion: 2019-09-15
• Completion: 2019-09-15
• First posted: 2019-07-12
• Last updated: 2019-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study