Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
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|ClinicalTrials.gov Identifier: NCT00361608|
Recruitment Status : Withdrawn
First Posted : August 8, 2006
Last Update Posted : July 19, 2016
|Condition or disease||Intervention/treatment|
|Type I Diabetes||Device: EarlySense ES 16|
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, heart rate, restlessness and tremor in sleep will be measured by the EarlySense device which is put in the patient's bed. These measured values will be compared to:
- glucose values measured by a "Guardian RT" device - an approved device for CBGM - Continuous Blood Glucose Measurement;
- glucose levels tested by SBGM -Self Blood Glucose Measurement.
These comparisons will show whether the EarlySense device is applicable in predicting hypoglycemia events in type I diabetes patients.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Observational Model:||Case Control|
|Official Title:||Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device|
|Study Start Date :||July 2008|
|Primary Completion Date :||May 2009|
|Study Completion Date :||May 2009|
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): NCT00361608
|Schneider Children's Medical Center of Israel|
|Petah-Tikva, Israel, 49202|
|Principal Investigator:||Liat de Vries, M.D.||Schneider Children's Medical Center, Israel|