Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

Type 1 Diabetes Clinical Trial

Official title:

A School Intervention: Lunch Time Insulin Injections in Children With Poorly Controlled Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00340613
• Other study ID #: H-16630
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2006
• Last updated: July 12, 2016
• Start date: June 2006
• Est. completion date: June 2007

Study information

• Verified date: July 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 19 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• glargine insulin

Locations

Country	Name	City	State
United States	Texas Children's Diabetes Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c		At the start of the study and again in 3 months
Secondary	Urine microalbumin		At the beginning and the end of the study