Status:
COMPLETED
Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense as a Tool for Detection of Hypoglycemia
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
Night Sense Ltd
Conditions:
Type 1 Diabetes
Nocturnal Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02225379
Start Date
September 1 2014
End Date
July 1 2016
Last Update
January 11 2017
Active Locations (1)
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1
Schneider Children's Medical Center
Petah Tikva, Israel, 49202