Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069602
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2003-09-29
Brief Title:
Assessing Continuous Glucose Monitors in Healthy Children
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
DirecNet Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus The purpose of this study was to determine whether two FDA-approved continuous glucose monitors the Continuous Glucose Monitoring System CGMS and the GlucoWatch G2TM Biographer GW2B are sufficiently accurate to use in future studies to characterize glucose levels in children
Detailed Description:
The characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes This study was conducted by the DirecNet Study Group to determine whether two FDA-approved continuous glucose monitors are sufficiently accurate
The study was conducted at five clinical centers and enrolled approximately 20 healthy children ages 7 to 17 years old who did not have Type 1 or Type 2 diabetes nor a history of the disease in their immediate families Each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations
The study was conducted at five clinical centers and enrolled approximately 20 healthy children ages 7 to 17 years old who did not have Type 1 or Type 2 diabetes nor a history of the disease in their immediate families Each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations
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 |
|---|---|---|---|
| HD041915 | None | None | None |
| HD041890 | None | None | None |
| HD041919-01 | None | None | None |
| HD041908-01 | None | None | None |
| HD041906-01 | None | None | None |
| HD041918-01 | None | None | None |