Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361608
Status:
WITHDRAWN
Last Update Posted:
2016-07-19
First Post:
2006-08-06
Brief Title:
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
Sponsor:
EarlySense Ltd
Organization:
EarlySense Ltd
Study Overview
Official Title:
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
Status:
WITHDRAWN
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4006 | None | None | None |