Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense as a Tool for Detection of Hypoglycemia
NCT ID: NCT02225379
Last Updated: 2017-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2014-09-30
2016-07-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Hypo-Sense (non invasive sensor)
Parallel measurements of capillary blood glucose using reference method and data generated by the non- invasive study device (Hypo Sense) during approximately 4 hours, in which a hypoglycemic event will be induced.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes diagnosed at least 12 months prior to study inclusion
* Age \> 18 years old
Exclusion Criteria
* Any significant disease or condition, including psychiatric disorders that in the opinion of the investigator is likely to affect patient's compliance or ability to complete the study
* Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
* Chronic skin problem in the lower inner arm
* Pregnant or breast feeding women
18 Years
65 Years
ALL
No
Sponsors
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Night Sense Ltd
UNKNOWN
Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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M Phillip, Prof
Role: PRINCIPAL_INVESTIGATOR
Schneider Children's Medical Center
Locations
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Schneider Children's Medical Center
Petah Tikva, , Israel
Countries
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Other Identifiers
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029514ctil
Identifier Type: -
Identifier Source: org_study_id
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