NCT02225379

Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense as a Tool for Detection of Hypoglycemia

Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense Sensor as a Tool for Detection of Hypoglycemia - Exploratory Study for Prototype Rev 1

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart \& respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device. The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to reference methods The proposed study will be consisting of two main segments: The primary aim of segment 1 of the study is data collection and calibration of the Hypo Sense sensor prototype compared to standard invasive reference glucometer. The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance in detecting hypoglycemic events. During the first segment of the study we intend to collect in parallel measurements of blood glucose using reference method (capillary glucometer) and continuous data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced. The reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will translate the set of the physiological recorded parameters into detection of hypoglycemic events. During the second segment of the study we intend to evaluate the validity of the Hypo Sense sensor ability to detect hypoglycemic events compared to standard invasive reference method (capillary glucometer).

Conditions

• Type 1 Diabetes
• Nocturnal Hypoglycemia

Interventions

Type	Name	Description
DEVICE	Hypo-Sense (non invasive sensor)	Parallel measurements of capillary blood glucose using reference methods (both capillary glucometer and continuous sensor) and data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-08-26
• Last updated: 2017-01-11

Locations

1 site across 1 country: Israel