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Sponsors and Collaborators: |
EarlySense Ltd. Schneider Children's Medical Center, Israel |
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Information provided by: | EarlySense Ltd. |
ClinicalTrials.gov Identifier: | NCT00361608 |
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.
Condition | Intervention |
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Type I Diabetes |
Device: EarlySense ES 16 |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device |
Estimated Enrollment: | 30 |
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:
These comparisons will show whether the EarlySense device is applicable in predicting hypoglycemia events in type I diabetes patients.
Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Schneider Children's Medical Center of Israel | |
Petah-Tikva, Israel, 49202 |
Principal Investigator: | Liat de Vries, M.D. | Schneider Children's Medical Center, Israel |
Study ID Numbers: | ES-CI 03, 4006 |
Study First Received: | August 6, 2006 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00361608 |
Health Authority: | Israel: Ministry of Health |
diabetes hypoglycemia monitor children with Type I Diabetes |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypoglycemia |
Immune System Diseases |