Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357890
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2006-07-26
Brief Title:
Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes T1D
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
Official Title:
A Pilot Study of the Effect of Continuous Subcutaneous Insulin Infusion in Adolescents With Newly-diagnosed Type 1 Diabetes on Insulin Resistance Beta-cell Function and the Honeymoon Period
Status:
COMPLETED
Status Verified Date:
2023-07
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:
Within 4 weeks after diagnosis of type 1 diabetes 10 subjects pubertal males 12-17 years old will be randomized to either receive multiple daily injection MDI using Lantus insulin or continuous subcutaneous insulin infusion CSII pump therapy The study evaluates how these modes of therapy affect insulin sensitivity measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes and beta cell function measured by mixed meal tolerance testing
Detailed Description:
Within 4 weeks after diagnosis of type 1 diabetes 10 subjects pubertal males 12-17 years old will be randomized to either receive multiple daily injection MDI using Lantus insulin or continuous subcutaneous insulin infusion CSII pump therapy The proposed protocol compares the changes in diabetes control between pump therapy and MDI treatment groups More importantly however the study evaluates how these modes of therapy may affect the honeymoon period and glycemic control specifically focusing on changes in insulin sensitivity measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes and beta cell function measured by mixed meal tolerance testing Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may have important therapeutic implications that could influence the standard of care in pediatric diabetes
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