Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

Type I Diabetes Clinical Trial

Official title:

Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00361608
• Other study ID #: ES-CI 03
• Secondary ID: 4006
• Status: Withdrawn
• Phase: N/A
• First received: August 6, 2006
• Last updated: July 17, 2016
• Start date: July 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2008
• Source: EarlySense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type I Diabetes

Intervention

Device:
• EarlySense ES 16

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petah-Tikva

Sponsors (2)

Lead Sponsor	Collaborator
EarlySense Ltd.	Schneider Children's Medical Center, Israel

Country where clinical trial is conducted

Israel,