Type 1 Diabetes Clinical Trial
Official title:
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
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).
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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