Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146484
Status:
COMPLETED
Last Update Posted:
2005-09-07
First Post:
2005-09-06
Brief Title:
A Study of Two Versus Three Daily Injections in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
Sponsor:
Childrens Hospital of Eastern Ontario
Organization:
Childrens Hospital of Eastern Ontario
Study Overview
Official Title:
A Randomized Controlled Trial of Two Versus Three Daily Insulin Injections in Children and Adolescents With New Onset Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2005-09
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:
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown The purpose of this study is to determine whether a split evening injection regimen insulin injections before breakfast supper and bedtime leads to better glucose control and quality of life than twice daily insulin in children and adolescents with new onset diabetes
Detailed Description:
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown No published studies have examined the effectiveness of a split evening three times daily injection regimen in this group of patients Indeed because the first few years of diabetes management are the easiest due to a honeymoon period characterised by residual insulin secretion the potential for any benefit from more intensive management ie three daily injections may be small during this period In addition the intensity of the initial insulin regimen may be an important determinant of quality of life family functioning and subsequent compliance with diabetes regimens A randomized controlled trial has been designed to test the hypothesis that a split evening injection regimen leads to better glycemic control and quality of life than twice daily insulin in children and adolescents with new onset 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