Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

EarlySense

Status: Withdrawn

Conditions: Type I Diabetes

Treatments: Device: EarlySense ES 16

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00361608

ES-CI 03

4006

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.