NCT00361608

Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: EarlySense Ltd. · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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 pediatric type I diabetes patients.

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, 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: 1. glucose values measured by a "Guardian RT" device - an approved device for CBGM - Continuous Blood Glucose Measurement; 2. 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.

Conditions

• Type I Diabetes

Interventions

Type	Name	Description
DEVICE	EarlySense ES 16

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2006-08-08
• Last updated: 2016-07-19

Locations

1 site across 1 country: Israel