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Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

Baylor College of Medicine logo

Baylor College of Medicine

Status and phase

Completed
Phase 4

Conditions

Type 1 Diabetes

Treatments

Drug: glargine insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT00340613
H-16630

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

10 to 19 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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