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Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

This study has been completed.
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00340613
First received: June 19, 2006
Last updated: July 16, 2008
Last verified: July 2008
History of Changes
  Purpose

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 Intervention Phase
Type 1 Diabetes
 Drug: glargine insulin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A School Intervention: Lunch Time Insulin Injections in Children With Poorly Controlled Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

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

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

Enrollment: 36
Study Start Date: June 2006
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340613

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

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00340613     History of Changes
Other Study ID Numbers: H-16630
Study First Received: June 19, 2006
Last Updated: July 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Type 1 Diabetes
Poorly controlled glucose
adolescents

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

ClinicalTrials.gov processed this record on June 17, 2013