Ignite Creation Date:
2024-05-06 @ 10:11 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03182842
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2017-06-07
Brief Title:
FreeStyle Libre FGM During Summer Camp for Children With Type 1 Diabetes
Sponsor:
University of Ljubljana Faculty of Medicine
Organization:
University of Ljubljana Faculty of Medicine
Study Overview
Official Title:
Evaluation of FreeStyle Libre Flash Glucose Monitoring System During a Children With Type 1 Diabetes Summer Camp - The Free Summer Study
Status:
COMPLETED
Status Verified Date:
2017-07
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:
A randomized double-blinded single center parallel design pediatric study on 45 subjects with type 1 diabetes T1D aged six to 15 inclusive years measuring sensor time in glucose values within range 39 - 10 mmoll 70 - 180 mgdl achieved using the FreeStyle Libre Flash Glucose Monitoring System FGM - intervention Abbott Diabetes Care California USA versus Self-Monitoring Blood Glucose SMBG - control
Study duration will be two weeks per subject and two weeks overall it will take place at youth summer camp for children with T1D Main inclusion criteria include age of six to 15 inclusive years clinical diagnosis of T1D for at least six months at least three months of current use of insulin pump therapy HbA1c between 63 and 10 both inclusive no other chronic medical conditions beside treated hypothyroidism and celiac disease and no current medications other than insulin detailed list of inclusion and exclusion criteria list can be found at section 6
The objectives of this clinical investigation is
1 to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with T1D during two weeks of summer camp
Study duration will be two weeks per subject and two weeks overall it will take place at youth summer camp for children with T1D Main inclusion criteria include age of six to 15 inclusive years clinical diagnosis of T1D for at least six months at least three months of current use of insulin pump therapy HbA1c between 63 and 10 both inclusive no other chronic medical conditions beside treated hypothyroidism and celiac disease and no current medications other than insulin detailed list of inclusion and exclusion criteria list can be found at section 6
The objectives of this clinical investigation is
1 to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with T1D during two weeks of summer camp
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None