Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069537
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2003-09-29
Brief Title:
Continuous Glucose Monitors for Children With Diabetes Mellitus
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
DirecNet Inpatient Study to Test the Accuracy of Continuous Blood Glucose Monitoring Devices in Children With Type 1 Diabetes
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:
Good control of blood glucose levels is important in preventing complications from diabetes This study assessed the accuracy and reliability of two FDA-approved continuous glucose monitors the Continuous Glucose Monitoring System CGMS and the GlucoWatch G2 Biographer GW2B in children with type 1 diabetes mellitus T1DM
Detailed Description:
Intensive control of blood glucose levels has been shown to substantially prevent or delay complications of T1DM in adolescents and adults The major limitation to implementation of intensive glycemic control is hypoglycemia Younger children may be at increased risk for hypoglycemia and the riskbenefit ratio of intensive glycemic control may be less favorable in this population Intensive therapy has not been systematically evaluated in children less than 13 years of age This study was conducted by the Diabetes Research in Children Network DirecNet to assess the accuracy of the CGMS and the GW2B glucose monitors in comparison with standard blood glucose measurements in an inpatient setting
During 24-hour clinical research center stays at five clinical centers approximately 90 children and adolescents with T1DM 1 to 17 years of age wore two FDA-approved continuous glucose monitors CGMS and GW2B and had frequent serum glucose determinations during the day and night To assess glucose monitor function during periods of rising and falling blood glucose insulin-induced hypoglycemia and meal-induced hyperglycemia tests were also performed
During 24-hour clinical research center stays at five clinical centers approximately 90 children and adolescents with T1DM 1 to 17 years of age wore two FDA-approved continuous glucose monitors CGMS and GW2B and had frequent serum glucose determinations during the day and night To assess glucose monitor function during periods of rising and falling blood glucose insulin-induced hypoglycemia and meal-induced hyperglycemia tests were also performed
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 |