Skip to main content
OpenTrials
Completed

NCT Number: NCT00340613

Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Texas Children's Diabetes Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glargine insulin

Drug

Primary outcomes

  1. Hemoglobin A1c

    Time frame: At the start of the study and again in 3 months

Secondary outcomes

  1. Urine microalbumin

    Time frame: At the beginning and the end of the study

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Jun 21, 2006
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.