Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

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

Sponsors

Lead Sponsor: Baylor College of Medicine

Source 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.

Overall Status Completed
Start Date June 2006
Completion Date June 2007
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemoglobin A1c At the start of the study and again in 3 months
Secondary Outcome
Measure Time Frame
Urine microalbumin At the beginning and the end of the study
Enrollment 36
Condition
Intervention

Intervention Type: Drug

Intervention Name: glargine insulin

Eligibility

Criteria:

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

Gender: All

Minimum Age: 10 Years

Maximum Age: 19 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Rubina A Heptulla, MD Principal Investigator Baylor College of Medicine
Location
Facility: Texas Children's Diabetes Center
Location Countries

United States

Verification Date

July 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Baylor College of Medicine

Investigator Full Name: Sponsored Programs

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov