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Clinical Trial NCT00361608 for Type I Diabetes is withdrawn. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device Pediatric
Clinical Trial NCT00361608 is an observational study for Type I Diabetes that is withdrawn. It started on 1 July 2008 with plans to enroll N/A participants. Led by EarlySense Ltd., it is expected to complete by 1 May 2009. The latest data from ClinicalTrials.gov was last updated on 19 July 2016.
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.
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:
- glucose values measured by a "Guardian RT" device -...
Official Title
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
Conditions
Type I DiabetesOther Study IDs
- ES-CI 03
- 4006
NCT ID Number
Start Date (Actual)
2008-07
Last Update Posted
2016-07-19
Completion Date (Estimated)
2009-05
Study Type
Observational
Status
Withdrawn
Keywords
diabetes
hypoglycemia
monitor
children with Type I Diabetes
hypoglycemia
monitor
children with Type I Diabetes
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | EarlySense ES 16 |
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
12 Years
Eligible Sexes
All
- 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.
- 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.
EarlySense Ltd.Schneider Children's Medical Center, IsraelNo contact data.
1 Study Locations in 1 Countries
Schneider Children's Medical Center of Israel, Petah Tikva, 49202, Israel