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Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

This study has been completed.
Sponsor:
Collaborator:
Schneider Children's Medical Center, Israel
Information provided by:
EarlySense Ltd.
ClinicalTrials.gov Identifier:
NCT00361608
First received: August 6, 2006
Last updated: April 22, 2008
Last verified: April 2008
History of Changes
  Purpose

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: Time Perspective: Prospective
Official Title: Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EarlySense Ltd.:

Estimated Enrollment: 30
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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361608

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

No publications provided

ClinicalTrials.gov Identifier: NCT00361608     History of Changes
Other Study ID Numbers: ES-CI 03, 4006
Study First Received: August 6, 2006
Last Updated: April 22, 2008
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013