Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00340613
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : July 14, 2016
Information provided by (Responsible Party):
Sponsored Programs, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: glargine insulin Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A School Intervention: Lunch Time Insulin Injections in Children With Poorly Controlled Type 1 Diabetes
Study Start Date : June 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: At the start of the study and again in 3 months ]

Secondary Outcome Measures :
  1. Urine microalbumin [ Time Frame: At the beginning and the end of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00340613

United States, Texas
Texas Children's Diabetes Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Principal Investigator: Rubina A Heptulla, MD Baylor College of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sponsored Programs, Principal Investigator, Baylor College of Medicine Identifier: NCT00340613     History of Changes
Other Study ID Numbers: H-16630
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Sponsored Programs, Baylor College of Medicine:
Type 1 Diabetes
Poorly controlled glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs