Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

Phase 4

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT00340613
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-21
• Study Completion: 2007-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Child with T1DM for at least 1 year
• Age 10-19 years
• Have a Hgb A1C greater than or equal to 9.0% but less than or equal 13.9% for at least 6 months.
• School must have a school nurse

Exclusion Criteria

• Child who has Type 2 diabetes
• Subject receiving home schooling

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	At the start of the study and again in 3 months

Secondary Outcome Measures

Name	Time	Method
Urine microalbumin	At the beginning and the end of the study

Trial Locations

Locations (1)

Texas Children's Diabetes Center; 🇺🇸 Houston, Texas, United States