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Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

This study has been withdrawn prior to enrollment.
Schneider Children's Medical Center, Israel
Information provided by (Responsible Party):
EarlySense Ltd. Identifier:
First received: August 6, 2006
Last updated: July 17, 2016
Last verified: April 2008
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
Type I Diabetes Device: EarlySense ES 16

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

Resource links provided by NLM:

Further study details as provided by EarlySense Ltd.:

Enrollment: 0
Study Start Date: July 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diabetes I

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00361608

Schneider Children's Medical Center of Israel
Petah-Tikva, Israel, 49202
Sponsors and Collaborators
EarlySense Ltd.
Schneider Children's Medical Center, Israel
Principal Investigator: Liat de Vries, M.D. Schneider Children's Medical Center, Israel
  More Information

Responsible Party: EarlySense Ltd. Identifier: NCT00361608     History of Changes
Other Study ID Numbers: ES-CI 03
Study First Received: August 6, 2006
Last Updated: July 17, 2016

Keywords provided by EarlySense Ltd.:
children with Type I Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on June 23, 2017