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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Recruitment Status : Withdrawn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
Schneider Children's Medical Center, Israel
Information provided by (Responsible Party):
EarlySense Ltd.

Brief 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.

Condition or disease Intervention/treatment
Type I Diabetes Device: EarlySense ES 16

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.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
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

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U.S. FDA Resources

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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
Sponsors and Collaborators
EarlySense Ltd.
Schneider Children's Medical Center, Israel
Principal Investigator: Liat de Vries, M.D. Schneider Children's Medical Center, Israel

Responsible Party: EarlySense Ltd.
ClinicalTrials.gov Identifier: NCT00361608     History of Changes
Other Study ID Numbers: ES-CI 03
First Posted: August 8, 2006    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: April 2008

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