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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00340613

Enrollment

Registered

2006-06-21

Start date

2006-06-30

Completion date

2007-06-30

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes, Poorly controlled glucose, adolescents

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.

Interventions

DRUGglargine insulin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 19 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1c	At the start of the study and again in 3 months

Secondary

Measure	Time frame
Urine microalbumin	At the beginning and the end of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026