Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340613
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2006-06-19
Brief Title:
Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
A School Intervention Lunch Time Insulin Injections in Children With Poorly Controlled Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2016-07
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:
We hypothesize that checking blood sugar and taking long and short acting insulin before lunch at school may improve overall blood sugar control grades and decreases school absences in children and teens with poorly controlled T1DM
Detailed Description:
The Diabetes Control and Complications Trial DCCT for type 1Diabetes T1DM showed the importance of intensified diabetes control in helping reduce complications associated with poorly controlled diabetes However adolescents with T1DM continue to be a high-risk population due to the difficulties in coping with the physical emotional and social demands associated with managing diabetes themselves
We propose to use the school nurse to help with lunchtime blood sugar monitoring BSM and with a lunchtime insulin injection We want to see if this will improve blood sugar control improve school grades and decrease absences from school in adolescents with poorly controlled diabetes Subjects will receive 12 weeks of this treatment to see if they will have improved glucose control We hope to improve blood sugar control school grades and decrease absences from school in teens with poorly controlled diabetes
We propose to use the school nurse to help with lunchtime blood sugar monitoring BSM and with a lunchtime insulin injection We want to see if this will improve blood sugar control improve school grades and decrease absences from school in adolescents with poorly controlled diabetes Subjects will receive 12 weeks of this treatment to see if they will have improved glucose control We hope to improve blood sugar control school grades and decrease absences from school in teens with poorly controlled 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