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Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
glargine insulin
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Poorly controlled glucose, adolescents

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Texas Children's Diabetes Center

Outcomes

Primary Outcome Measures

Hemoglobin A1c

Secondary Outcome Measures

Urine microalbumin

Full Information

First Posted
June 19, 2006
Last Updated
July 12, 2016
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00340613
Brief Title
Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes
Official Title
A School Intervention: Lunch Time Insulin Injections in Children With Poorly Controlled Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Poorly controlled glucose, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
glargine insulin
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Time Frame
At the start of the study and again in 3 months
Secondary Outcome Measure Information:
Title
Urine microalbumin
Time Frame
At the beginning and the end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubina A Heptulla, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Diabetes Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18847622
Citation
Nguyen TM, Mason KJ, Sanders CG, Yazdani P, Heptulla RA. Targeting blood glucose management in school improves glycemic control in children with poorly controlled type 1 diabetes mellitus. J Pediatr. 2008 Oct;153(4):575-8. doi: 10.1016/j.jpeds.2008.04.066.
Results Reference
derived

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Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

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