Long Term Effects of Diabetes of Very Young Children



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:6 - 10
Updated:4/21/2016
Start Date:August 2005
End Date:January 2010

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To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years
diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3
years) compared to a group of children matched for age, sex, glycemic control, and diabetes
duration treated with insulin injections. Outcome measures will assess: clinical variables,
cognitive status (intelligence, neuropsychological functioning), academic achievement,
behavior, parenting stress, and quality of life.

It is hypothesized that long term insulin pump therapy initiated during early childhood can
delay the progression of neurocognitive complications of diabetes, decrease parental stress,
and improve school performance and quality of life, as compared to insulin injections.


Inclusion Criteria:

- Subjects must have type 1 diabetes for at least 5 years, diagnosed prior to the age
of 5 years

- Children recruited on pumps must have used pump therapy for at least 3 years

- Parents/guardians must be understand the protocol and be able to give consent, with
assent obtained from all children over the age of 7 years.

Exclusion Criteria:

- Children will be excluded if they have additional medical problems requiring
treatment with agents known to affect blood glucose such as steroids or
L-asparaginase.

- Children must not have any other chronic illness in addition to diabetes with the
exception of treated autoimmune hypothyroidism.
We found this trial at
1
site
705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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mi
from
Indianapolis, IN
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