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

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ClinicalTrials.gov Identifier: NCT02225379
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Night Sense Ltd
Information provided by (Responsible Party):
Rabin Medical Center

Brief 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).


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Nocturnal Hypoglycemia Device: Hypo-Sense (non invasive sensor) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : September 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Sensitivity [ Time Frame: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study) ]
    Sensitivity of the Hypo Sense-the proportion of hypoglycemia events detected by the Hypo Sense sensor from total number of hypoglycemic events detected by reference capillary glucometer

  2. Positive Predictive Value of the hypo-Sense [ Time Frame: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study) ]
    Positive Predictive Value of the hypo sense- the proportion of validated ("true") hypoglycemia events detected by the hypo sense sensor from total alerts detected by the Hypo-Sense sensor



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signing an inform consent form prior to any trial related procedure
  • Type 1 diabetes diagnosed at least 12 months prior to study inclusion
  • Age > 18 years old

Exclusion Criteria:

  • Participating in other device or drug study
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225379


Locations
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Israel
Schneider Children's Medical Center
Petah-Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Night Sense Ltd
Investigators
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Principal Investigator: M Phillip, Prof Schneider Children's Medical Center
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02225379    
Other Study ID Numbers: 029514ctil
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by Rabin Medical Center:
Type 1 Diabetes
Hypoglycemia detection
Non-invasive sensor
Nocturnal hypoglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases