- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00340613
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
Study Overview
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Texas Children's Diabetes Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemoglobin A1c
Time Frame: At the start of the study and again in 3 months
|
At the start of the study and again in 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urine microalbumin
Time Frame: At the beginning and the end of the study
|
At the beginning and the end of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: RUBINA A HEPTULLA, MD, Baylor College of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-16630
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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