Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device|
|Study Start Date:||July 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|