Status:
WITHDRAWN
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
Lead Sponsor:
EarlySense Ltd.
Collaborating Sponsors:
Schneider Children's Medical Center, Israel
Conditions:
Type I Diabetes
Eligibility:
All Genders
12-18 years
Brief Summary
This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in ped...
Detailed Description
The study patients are children, 12-18 years old, suffering from type I diabetes. Each patient will participate in the trial for 30 days. During this period of time the patients' breathing patterns, ...
Eligibility Criteria
Inclusion
- Age between 12-18 years
- Diagnosis of type I diabetes for at least a year
- Home close to participating center
- Guardian able and willing to cooperate with the trial for at least 1 month and prepared to sign the Informed Consent Form.
Exclusion
- Recent (within 3 months) admission to emergency room or intensive care unit (ICU) due to any condition unrelated directly to diabetes.
- Any other pre-existing medical pathology unrelated to diabetes.
- Inability of the patient or his guardian to use the Guardian RT.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00361608
Start Date
July 1 2008
End Date
May 1 2009
Last Update
July 19 2016
Active Locations (1)
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1
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202